Smith & Nephew Hip Systems

K211176 · Smith & Nephew, Inc. · LPH · Jul 1, 2022 · Orthopedic

Device Facts

Record IDK211176
Device NameSmith & Nephew Hip Systems
ApplicantSmith & Nephew, Inc.
Product CodeLPH · Orthopedic
Decision DateJul 1, 2022
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3358
Device ClassClass 2
AttributesTherapeutic

Intended Use

The components are indicated for the following: 1. Non-inflammatory degenerative joint disease including osteonecrosis, avascular necrosis and post traumatic arthritis; 2. Rheumatoid arthritis; 3. Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; 4. Revision procedures where other treatment or devices have failed; and 5. Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

Device Story

Smith & Nephew Hip Systems are orthopedic prosthetic implants for total or partial hip arthroplasty. Devices replace damaged hip joint components to restore function and mobility. Systems include femoral stems, acetabular shells, liners, and femoral heads. Implants are surgically placed by orthopedic surgeons in hospital settings. This submission updates labeling to "MR Conditional" status based on bench testing. No changes to device design, materials, or manufacturing. Output is a restored hip joint structure; clinical benefit is pain relief and improved joint function.

Clinical Evidence

Bench testing only. Testing performed per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (2021) and relevant standards including ASTM F2182-19e2 (RF heating), ASTM F2052-15 (displacement force), ASTM F2213-2017 (torque), and ASTM F2119-07 (image artifacts).

Technological Characteristics

Passive orthopedic hip implants. Materials, design, and manufacturing remain unchanged from predicate devices. Testing conducted for MR compatibility (RF heating, displacement force, torque, image artifacts) per ASTM F2182, F2052, F2213, and F2119 standards.

Indications for Use

Indicated for primary and revision hip surgery in patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, pelvic fracture, diastrophic variant), inflammatory degenerative joint disease (rheumatoid arthritis, congenital dysplasia), nonunion, femoral neck/trochanteric fractures, fracture dislocation, and functional deformity correction.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other. Smith & Nephew, Inc. Michelle Huettner Director, Regulatory Affairs, Orthopaedic Division 1450 East Brooks Rd Memphis. Tennessee 38116 Re: K211176 Trade/Device Name: Smith & Nephew Hip Systems Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, LPH, MEH, LZO, KWY, MBL, KWZ Dated: May 31, 2022 Received: June 1, 2022 Dear Rose Beifuss: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure: List of Cleared Devices in K211176 {2}------------------------------------------------ ### List of Cleared Devices in K211176 - 1. Anthology Hip System MR Conditional - 2. BH Dual Mobility System MR Conditional - 3. Contour Acetabular System MR Conditional - 4. CPCS Cemented Hip System MR Conditional - 5. Echelon Hip System MR Conditional - 6. Femoral Heads MR Conditional - 7. HI Cup MR Conditional - 8. Modular Hip Stems MR Conditional - 9. POLARCUP MR Conditional - 10. POLARSTEM MR Conditional, - 11. R3 Acetabular System MR Conditional - 12. Redapt Monoblock Revision Femoral System MR Conditional - 13. Redapt Revision Acetabular System MR Conditional - 14. Reflection Acetabular System Metal Shell MR Conditional - 15. Reflection All-Poly Cup MR Conditional - 16. Short Monoblock Femoral (SMF) Hip System MR Conditional - 17. SL-Plus and SLR-Plus Cementless Femoral Hip System MR Conditional - 18. Spectron EF Hip System MR Conditional - 19. Synergy Hip System MR Conditional - 20. Tandem Bipolar/Unipolar Hip System MR Conditional {3}------------------------------------------------ 510(k) Number (if known) #### K211176 Device Name Tandem Bipolar/Unipolar Hip System Indications for Use (Describe) The components are indicated for the following: 1. Non-inflammatory degenerative joint disease including osteonecrosis, avascular necrosis and post traumatic arthritis; 2. Rheumatoid arthritis; 3. Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; 4. Revision procedures where other treatment or devices have failed; and 5. Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {4}------------------------------------------------ 510(k) Number (if known) K211176 Device Name Synergy Hip System #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID/D) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {5}------------------------------------------------ 510(k) Number (if known) K211176 Device Name Spectron EF Hip System #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {6}------------------------------------------------ 510(k) Number (if known) #### K211176 #### Device Name SL-Plus and SLR-Plus Cementless Femoral Hip System #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {7}------------------------------------------------ 510(k) Number (if known) #### K211176 Device Name Short Monoblock Femoral (SMF) Hip System #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {8}------------------------------------------------ 510(k) Number (if known) K211176 Device Name Reflection All-Poly Cup #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {9}------------------------------------------------ 510(k) Number (if known) #### K211176 Device Name Reflection Acetabular System - Metal Shell #### Indications for Use (Describe) The components are intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| > | Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {10}------------------------------------------------ 510(k) Number (if known) K211176 Device Name Redapt Revision Acetabular System #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped captal epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {11}------------------------------------------------ 510(k) Number (if known) K211176 Device Name Redapt Monoblock Revision Femoral System #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID/D) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. | | | | Type of Use (Select one or both, as applicable) | | | |--|--|--|-------------------------------------------------|--|--| | | | | | | | | | | | | | | | | | | | | | > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {12}------------------------------------------------ 510(k) Number (if known) K211176 Device Name R3 Acetabular System #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {13}------------------------------------------------ 510(k) Number (if known) K211176 Device Name POLARSTEM Indications for Use (Describe) 1. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis. 2. Fracture or avascular necrosis of the femoral head 3. Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement The POLARSTEM with Ti/HA is intended for single use only and is to be implanted without bone cement. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {14}------------------------------------------------ 510(k) Number (if known) K211176 Device Name POLARCUP #### Indications for Use (Describe) 1. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis. 2. Fracture or avascular necrosis of the femoral head 3. Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement 4. All forms of osteoarthritis 5. Patients with hips at risk of dislocation 6. Femoral neck fracture or proximal fracture to hip joint The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement> The POLARCUP Dual Mobility System is intended for single use only. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {15}------------------------------------------------ 510(k) Number (if known) K211176 Device Name Modular Hip Stems Indications for Use (Describe) The indications for use in total hip arthoplasty include rheumatoid arthritis; post-traumatic arthritis; avascular necrosis and femoral neck fractures. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." EF {16}------------------------------------------------ 510(k) Number (if known) K211176 Device Name HI Cup #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID/D) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {17}------------------------------------------------ 510(k) Number (if known) K211176 Device Name Femoral Heads #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID/D) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {18}------------------------------------------------ 510(k) Number (if known) K211176 Device Name Echelon Hip System #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID/D) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {19}------------------------------------------------ 510(k) Number (if known) #### K211176 Device Name CPCS Cemented Hip System #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID/D) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {20}------------------------------------------------ 510(k) Number (if known) K211176 Device Name Contour Acetabular System #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {21}------------------------------------------------ 510(k) Number (if known) K211176 Device Name BH Dual Mobility System Indications for Use (Describe) The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BHR) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." EF {22}------------------------------------------------ 510(k) Number (if known) K211176 Device Name Anthology Hip System #### Indications for Use (Describe) Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID/D) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip. fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov {23}------------------------------------------------ ### 510(k) Summary | Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>7135 Goodlett Farms Parkway<br>Cordova, Tennessee 38016 | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date of Submission: | 31May2022 | | Contact Person: | Rose Beifuss<br>Regulatory Affairs Specialist II<br>T +1.385.253.2551 | | Name of Device: | Smith & Nephew Hip Systems: Anthology Hip<br>System, BH Dual Mobility System, Contour<br>Acetabular System, CPCS Cemented Hip System<br>Echelon Hip System, Femoral Heads, HI Cup<br>Modular Hip Stems, Polarcup, Polarstem, R3<br>Acetabular System, Redapt Monoblock Revision<br>Femoral System, Redapt Revision Acetabula<br>System, Reflection Acetabular System - Metal Shell<br>Reflection All-Poly Cup, Short Monoblock Femora<br>(SMF) Hip System, SL-Plus and SLR-Plus<br>Cementless Femoral Hip System, Spectron EF Hip<br>System, Synergy Hip System and Tandem<br>Bipolar/Unipolar Hip System. | | Common Name: | Hip Stem, Acetabular Component, , Prosthetic Hip<br>Joint- HA Coated Porous Femoral Stem, Femoral | | | Component, Cementless, Acetabular Liners, Femoral<br>Hip Prosthesis, Total Hip Joint, Acetabular<br>Component, Constrained Liner, Bipolar System | | Device Classification Name<br>and Reference: | 21 CFR 888.3350- Hip joint metal/polymer semi-<br>constrained cemented prosthesis,<br>21 CFR 888.3358 – Hip joint metal/polymer/metal<br>semi-constrained porous-coated uncemented<br>prosthesis,<br>CFR 888.3390- Hip joint femoral (hemi-hip)<br>metal/polymer cemented or uncemented prosthesis,<br>21 CFR 888.3353- Hip joint metal/ceramic/polymer<br>semi-constrained cemented or nonporous<br>uncemented prosthesis,<br>21 CFR 888.3360 – Hip joint femoral (hemi-hip)<br>metallic cemented or uncemented prosthesis<br>21 CFR 888.3310 Prothesis, hip, constrained,<br>cemented or uncemented metal/polymer | | Device Class: | Class II | | Panel Code: | Orthopaedics/87 | | Product Code: | JDI , LPH, MEH, LZO, KWY, MBL, KWZ | | Primary Predicate Device: | Anthology Hip System | Femoral Heads and Acetabular Liners, Total Hip Joint, {24}------------------------------------------------ {25}------------------------------------------------ # Additional Predicate Devices: BH Dual Mobility System, Contour Acetabular System, CPCS Cemented Hip System, Echelon Hip System, Femoral Heads, HI Cup, Modular Hip Stems, Polarcup, Polarstem, R3 Acetabular System, Redapt Monoblock Revision Femoral System, Redapt Revision Acetabular System, Reflection Acetabular System - Metal Shell, Reflection All-Poly Cup, Short Monoblock Femoral (SMF) Hip System, SL-Plus and SLR-Plus Cementless Femoral Hip System, Spectron EF Hip System, Synergy Hip System and Tandem Bipolar/Unipolar Hip System. {26}------------------------------------------------ ### Device Description: The purpose of this Traditional 510(k) is to add "MR Conditional" labeling to the subject Smith & Nephew Hip Systems. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modifications have been made to the devices' design, material, sterilization and the manufacturing processes of the previously cleared devices. ### Indications for Use: ### Total Hip Systems Anthology, Contour Acetabular, CPCS Cemented, Echelon, Femoral Heads, HI Cup, R3 Acetabular, Redapt Monoblock Revision Femoral, Redapt Revision Acetabular, Reflection All-Poly Cup, Short Monoblock Femoral, SL-Plus and SLR-Plus Cementless Femoral, Spectron EF, Synergy, BH Dual Mobility Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. {27}------------------------------------------------ Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. ### Modular Hip Stems The indications for use in total hip arthroplasty include rheumatoid arthritis; osteoarthritis; post-traumatic arthritis; avascular necrosis and femoral neck fractures. ### POLARCUP 1. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis. 2. Fracture or avascular necrosis of the femoral head - 3. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement - 4. All forms of osteoarthritis - 5. Patients with hips at risk of dislocation - 6. Femoral neck fracture or proximal fracture to hip joint The titanium plasma and titanium/HA coated implants are intended to be implanted without bone cement. The uncoated implant is intended to be implanted with bone cement> ThePOLARCUP Dual Mobility System is intended for single use only. ### POLARSTEM 1. Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis - 2. Fracture or avascular necrosis of the femoral head - 3. Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, {28}------------------------------------------------ hemiarthroplasty, surface replacement arthroplasty, or total hip replacement The POLARSTEM with Ti/HA is intended for single use only and is to be implanted without bone cement. ### Reflection Acetabular System - Metal Shell The components are intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered. ### BH Dual Mobility System The BIRMINGHAM HIP Dual Mobility Insert is intended for use in BIRMINGHAM HIP Resurfacing (BH) System revision surgeries in cases where an acetabular cup is retained and the femoral component revised. # Partial Hip Systems Tandem Bipolar/Unipolar # Tandem Bipolar/Unipolar Hip System The components are indicated for the following: - 1. Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; - 2. Rheumatoid arthritis; - 3. Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; - 4. Revision procedures where other treatment or devices have failed; and - 5. Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. {29}------------------------------------------------ # Technological Characteristics The device design and material of the subject devices are the same as the predicate Smith & Nephew Hip Systems cleared under the premarket notifications listed in Table 6.1. ### Performance Data Below listed Magnetic Resonance Imaging (MRI) compatibility testing was conducted as per the FDA's guidance and the Standards listed below. - 1. FDA Guidance Document: "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff", 20 May 2021. - 2. Reporting of Computational Modeling Studies in Medical Device Submissions, Guidance for Industry and Food and Drug Administration Staff, September 21, 2016 - 3. IEC 60601-2-33 (Ed 3.2), "Medical electrical equipment -Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis" (2015). - 4. ASTM F2182-19e2, "Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging" (2020). - 5. ISO/TS 10974:2018(E) "Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device". - 6. ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment. - 7. ASTM F2213-2017 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment - 8. ASTM F2182-19 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging - 9. ASTM F2119-07 (2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants {30}------------------------------------------------ # Substantial Equivalence Information The subject Smith & Nephew Hip Systems are identical in design, technological characteristics, function of the devices, packaging and sterilization to the commercially available predicate devices listed in Table 6.1 below. The only differences between the subject devices and the commercially available predicate devices were supporting MR safety testing/assessment and the addition of "MR Conditional" information to the labeling. | Manufacturer | Description | Submission<br>Number | Clearance<br>Date | |-------------------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Smith & Nephew,<br>Inc. | Anthology Hip System | K052792 | 10/07/2005 | | Smith & Nephew,<br>Inc. | BH Dual Mobility System | K171934 | 11/30/2017 | | Smith & Nephew,<br>Inc. | Contour Acetabular System | K962541<br>K040680 | 09/17/1996<br>06/14/2004 | | Smith & Nephew,<br>Inc. | CPCS Cemented Hip System | K970351<br>K823727 | 02/28/1997<br>03/08/1983 | | Smith & Nephew,<br>Inc. | Echelon Hip System | K983834<br>K023302<br>K963486 | 02/24/1999<br>10/25/2002<br>11/27/1996 | | Smith & Nephew,<br>Inc. | Femoral Heads | K021673<br>K022902<br>K022958<br>K072817<br>K083762<br>K093363<br>K100412<br>K110101<br>K914878<br>K963509<br>K971414 | 06/11/2002<br>10/02/2002<br>10/02/2002<br>05/15/2008<br>03/11/2009<br>01/26/2010<br>05/05/2010<br>04/11/2011<br>07/30/1992<br>01/27/1997<br>07/16/1997 | | Smith & Nephew,<br>Inc. | HI Cup | K093991 | 04/15/2010 | | Smith & Nephew,<br>Inc. | Modular Hip Stems | K921400<br>K900628 | 04/02/1993<br>05/09/1990 | | Smith & Nephew,<br>Inc. | POLARCUP | K070278<br>K110135<br>K122244 | 04/16/2007<br>10/14/2011<br>08/23/2012 | | Smith & Nephew,<br>Inc. | POLARSTEM | K130728<br>K143739 | 10/10/2013<br>04/20/2015 | | Smith & Nephew,<br>Inc. | R3 Acetabular System | K070756<br>K083566<br>K092386<br>K093363<br>K102370<br>K113848<br>K182535 | 06/06/2007<br>03/03/2009<br>11/03/2009<br>01/26/2010<br>01/19/2011<br>04/27/2012<br>11/19/2018 | | Smith & Nephew,<br>Inc. | Redapt Monoblock Revision<br>Femoral System | K081124<br>K100481<br>K121627<br>K151902<br>K162303 | 07/31/2008<br>07/15/2010<br>10/15/2012<br>09/03/2015<br>05/01/2017 | | Smith & Nephew,<br>Inc. | Redapt Revision Acetabular<br>System | K150790<br>K160923<br>K171073<br>K182109 | 11/16/2015<br>11/17/2016<br>11/21/2017<br>11/16/2018 | | Smith & Nephew,<br>Inc. | Reflection Acetabular System -<br>Metal Shell | K002747<br>K021803<br>K022556<br>K022902<br>K033442<br>K071160<br>K920430<br>K932755<br>K990666<br>K960094 | 12/15/2000<br>12/19/2002<br>08/28/2002<br>10/02/2002<br>11/26/2003<br>10/05/2007<br>07/21/1992<br>05/06/1994<br>08/06/1999<br>03/27/1996 | | Smith & Nephew,<br>Inc. | Reflection All-Poly Cup | K002747 | 12/15/2000 | | Smith & Nephew,<br>Inc. | Short Monoblock Femoral (SMF)<br>Hip System | K103256<br>K123012 | 01/31/2011<br>10/24/2012 | | Smith & Nephew,<br>Inc. | SL-Plus and SLR-Plus Cementless<br>Femoral Hip System | K072852<br>K093991<br>K120211<br>K122296 | 06/09/2008<br>04/15/2010<br>07/19/2012<br>08/28/2012 | | Smith & Nephew,<br>Inc. | Spectron EF Hip System | K823723<br>K831884<br>K970351<br>K791125 | 03/09/1983<br>09/20/1983<br>02/28/1997<br>06/27/1979 | | Smith & Nephew,<br>Inc. | Synergy Hip System | K002996<br>K963509<br>K970337<br>K990369<br>K991485 | 12/11/2000<br>01/27/1997<br>02/28/1997<br>03/12/1999<br>07/12/1999 | | Smith & Nephew,<br>Inc. | Tandem Bipolar/Unipolar Hip<br>System | K023743<br>K896580<br>K934353 | 01/23/2003<br>02/15/1990<br>04/25/1994 | ### Table 6.1: Predicate Devices {31}------------------------------------------------ {32}------------------------------------------------ ### Conclusion In summary, the only differences between the subject devices and the commercially available predicate devices were supporting MR safety testing/assessment and the addition of MR safety information to the labeling. These differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the subject devices. The subject Smith & Nephew Hip Systems are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared and do not affect the safety and effectiveness of the subject devices when used as labeled. Due to the supporting documentation within this filing, it is conducted that the subject device(s) are substantially equivalent to the predicate device(s).
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510(k) Summary
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