DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional

K231873 · Depuy Ireland UC · MEH · Jan 19, 2024 · Orthopedic

Device Facts

Record IDK231873
Device NameDePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional
ApplicantDepuy Ireland UC
Product CodeMEH · Orthopedic
Decision DateJan 19, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3353
Device ClassClass 2
AttributesTherapeutic

Indications for Use

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Device Story

The DePuy Hip Portfolio consists of various orthopedic implants including femoral stems, acetabular shells, liners, femoral heads, and ancillary components (screws, plugs, spacers, cerclage systems). These devices are used in total or hemi-hip arthroplasty to replace damaged hip joint articulations. The implants are surgically implanted by orthopedic surgeons in a hospital setting. The devices provide structural support and articulation for the hip joint, aiming to restore mobility and reduce pain. This submission updates the labeling of these legacy devices to provide information regarding MRI compatibility, including the provision of MR Safety Cards for patients, and standardizes labeling symbols and documentation.

Clinical Evidence

Bench testing only. Non-clinical performance data (Magnetically Induced Displacement Force, Torque, RF Heating, and Image Artifacts) were provided to support the conditional safety of the devices in the MR environment.

Technological Characteristics

Devices are constructed from various orthopedic materials including stainless steel (ASTM F5832-9), titanium alloy (Ti6Al4V, ASTM F620), cobalt-chromium-molybdenum alloy (ASTM F75, F799), and UHMWPE (ASTM F648). Features include porous coatings (Porocoat, Gription), hydroxyapatite (HA) coatings, and modular designs. Connectivity is not applicable. Sterilization is not specified but implied as standard for orthopedic implants.

Indications for Use

Indicated for total hip replacement in patients with severely painful/disabled joints due to osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia; avascular necrosis of the femoral head; acute traumatic fracture of the femoral head or neck; failed previous hip surgery (joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement, or total hip replacement); or ankylosis. Hemi-hip replacement is indicated for acute femoral head/neck fractures, fracture dislocations, avascular necrosis, non-union of femoral neck fractures, high subcapital/femoral neck fractures in the elderly, degenerative arthritis of the femoral head, or proximal femur pathology.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 19, 2024 DePuy Ireland UC % Jennifer Hill Regulatory Affairs Project Leader DePuy Synthes 3 Main Street Ringaskiddy, Loughbeg Ireland Re: K231873 Trade/Device Name: DePuy SUMMIT Porocoat Hip Prosthesis - MR Conditional. DePuy SUMMIT DuoFix Hip Prosthesis - MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis - MR Conditional, DePuv SUMMIT FX Cemented Hip Prosthesis -MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis - MR Conditional Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: MEH, LPH, JDI, LWJ, LZO, KWL, KWY, LZY, HWC, LRN Dated: December 14, 2023 Received: December 14, 2023 Dear Jennifer Hill: 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 (the 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 available 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. {1}------------------------------------------------ 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, # Limin Sun S Limin Sun, Ph.D. 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 {3}------------------------------------------------ # FDA IFU FORMS 3381 {4}------------------------------------------------ # HIP STEMS FDA IFU FORMS 3381 {5}------------------------------------------------ #### 510(k) Number (if known) K942370/K961619 Device Name ENDURANCE CEMENTED HIP PROSTHESIS, ENDURANCE CALCAR PROSTHESIS #### Indications for Use (Describe) Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | | | |X 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) K982918/K013350/K042959/K082239/K220216/K093736/K851422/K910664/K934412/K961939/K903084/K073570 Device Name C-STEM SYSTEM, C-STEM AMT HIP PROSTHESIS, CORAIL REVISION HIP PROSTHESIS, S-ROM FEMORAL TOTA HIP SYSTEM, S-ROM TOTAL HIP SYSTEM, S-ROM COATED ZT PROXIMAL HIP SYSTEM, S-ROM FEMORAL HIP STEM, MODULAR CATHCART FRACTURE SYSTEM, TRI-LOCK BPS Indications for Use (Describe) Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The DePuy® C-Stem AMT Hip Stem is indicated for cemented use only. HA-coated stems of the CORAIL Hip System are indicated for cementless use only. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | 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) K102080/K221462 Device Name RECLAIM MODULAR REVISION HIP SYSTEM, RECLAIM MONOBLOC REVISION HIP SYSTEM #### Indications for Use (Describe) The DePuy RECLAIM Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------| | <span style="font-family:Wingdings;"> egative </span> | | | Over-The-Counter Use (21 CFR 801 Subpart C) | <input type="checkbox"/> | #### 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) K953703/K030979/K060581 Device Name VISION SOLUTION HIP PROSTHESIS, SOLUTION SYSTEM HIP PROSTHESIS #### Indications for Use (Describe) Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The Solution Hip Stem is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating as well as cemented use and fixation in which the porous coating serves as a means to augment the fixation of the prosthesis to the bone cement. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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) K001991/K011489/K013352/K023453/K030122/K202472/K210581/K211657/K192946 Device Name SUMMIT POROCOAT, SUMMIT DUOFIX, SUMMIT CEMENTED, SUMMIT FX CEMENTED, SUMMIT BASIC PRESS-FIT HIP PROSTHESIS, ACTIS DUOFIX, ACTIS DUOFIX COLLARLESS HIP PROSTHESIS, EMPHASYS FEMORAL STEM, CORAIL AMT HIP PROSTHESIS Indications for Use (Describe) Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Hemi hip replacement is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |--------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | 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}------------------------------------------------ # ACETABULAR PRODUCTS FDA IFU FORMS 3381 {11}------------------------------------------------ 510(k) Number (if known) K203532 #### Device Name BI-MENTUM ALTRX DUAL MOBILITY LINERS #### Indications for Use (Describe) BI-MENTUM™ ALTRX® Dual Mobility Liner is indicated for total hip replacement in the following conditions: - 1. Osteoarthritis - 2. Femoral neck fracture - 3. Dislocation risk - 4. Osteonecrosis of the femoral head 5. Revision procedures where other treatments or devices have failed are if bone reconstruction so permits | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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) K200854 Device Name PINNACLE DUAL MOBILITY LINER Indications for Use (Describe) Total hip replacement or hip arthroplasty is indicated in the following conditions: 1. A severely painful and/or disabled joint (typically due to non inflammatory degenerative joint disease). 2. Failed previous hip surgery. 3. Dislocation risks. PINNACLE Dual Mobility Metal Liners and Porous-coated PINNACLE Acetabular Cups are intended for cementless applications. Type of Use (Select one or both, as applicable)X 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) K072963, K102423, K132959, K090998, K093646, K033273, K001534 #### Device Name PINNACLE ALTRX ACETABULAR LINERS, PINNACLE 100 GRIPTION CUPS, PINNACLE GRIPTION CUPS, PINNACLE ACETABULAR ENHANCED STABILITY LINERS, PINNACLE ACETABULAR SYSTEM Indications for Use (Describe) Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Type of Use (Select one or both, as applicable) X 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) K03338. K192919. K040544. K951674. K961186. K994415. K010171. K863184. K221636 #### Device Name PINNACLE REVISION SYSTEM, PINNACLE DUOFIX HA ACETABULAR CUP, DURALOC OPTION CUP SYSTEM, DURALOC 100C CUP, DURALOC CEMENTLESS CUP SYSTEM, MARATHON CROSS-LINKED POLYETHYLENE CUP LINERS, 36MM MARATHON LINERS, PROFILE ACETABULUM PROSTHESIS, EMPHASYS ACETABULAR SYSTEM Indications for Use (Describe) Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. X 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}------------------------------------------------ # FEMORAL HEADS FDA IFU FORMS 3381 {16}------------------------------------------------ #### 510(k) Number (if known) K860701. K880269. K883460. K060031. K120599. K222296. K011533. K031803. K062748. K071830. K871867 Device Name HPS FEMORAL BALL HEADS, TOTAL HIP BALL FEMORAL HEADS, ARTICUL/EZE FEMORAL HEADS, MODULAR M HEADS, 36mm FEMORAL HEADS, ARTICUL/EZE CERAMIC HEADS, DELTA CERAMIC FEMORAL HEADS, DELTA TS CERAMIC FEMORAL HEADS, ELITE FEMORAL HEADS Indications for Use (Describe) Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. | Type of Use (Select one or both, as applicable) | | | |-------------------------------------------------|--|--| | | | | |X 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) K812672 Device Name SELF-CENTERING HIP #### Indications for Use (Describe) Self-Centering hip arthroplasty is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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) K851422/K920317 Device Name S-ROM FEMORAL HEADS Indications for Use (Describe) #### INDICATIONS - TOTAL HIP PROSTHESIS Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. - 3. Acute traumatic fracture of the femoral head or neck. 4. Certain cases of ankylosis. #### INDICATIONS - HEMI-HIP PROSTHESIS Hemi-hip arthroplasty is indicated in the following conditions: - 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treation. - 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. - 3. Avascular necrosis of the femoral head. - 4. Non-union of femoral neck fractures. - 5. Certain high subcapital and femoral neck fractures in the elderly. - 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |----------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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}------------------------------------------------ # COMPONENTS FDA IFU FORMS 3381 {20}------------------------------------------------ 510(k) Number (if known) K861979, K970929, K983014, K123924 #### Device Name DEPUY 5.0MM TAPERED HEAD PERIPHERAL SCREW, LOW PROFILE BONE SCREW, ACETABULAR SYSTEM SCREWS, GRIPTION TF 5.5mm LOCKING SCREWS #### Indications for Use (Describe) The DePuy Screws are indicated for use in primary or revision hip surgery for total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoir arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {21}------------------------------------------------ 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 {22}------------------------------------------------ 510(k) Number (if known) K963309 Device Name DEPUY APEX HOLE ELIMINATOR PS #### Indications for Use (Describe) The Apex Hole Eliminator PS is a threaded plug intended to close the apical hole of the Duraloc series two-piece (metal shell and UHMWPe liner) acetabular cups. It is intended for use in Duraloc cups implanted with or without bone cement. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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) Number (if known) K971682 Device Name DEPUY J-FX CERCLAGE SYSTEM #### Indications for Use (Describe) The I-Fx Cerclage System is indicated for use as a cerclage fixation device in general orthopaedic repairs. These include procedures such as: reinforcement of bone; reattachment of the greater trochanter; fixation of long bone fractures with grafting; and fixation of patellar 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 {24}------------------------------------------------ 510(k) Number (if known) K100391 Device Name DEPUY GRIPTION TF CONES & HIP AUGMENTS Indications for Use (Describe) The DePuy Gription TF Acetabular Augments, Buttresses and Shims are in total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoir arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The porous Gription TF titanium acetabular augment is affixed to the mating acetabular cup using bone cement or mechanical screw fixation. The assembled porous titanium augment is intended for cemented or cementless use. The porous Gription TF titanium shim is affixed to the mating buttress using bone cement. This porous Gription TF titanium buttress is affixed to the mating acetabular cup using bone cement. The assembled buttress/acetabular cup construct is intended for cemented or cementless use. {25}------------------------------------------------ Type of Use (Select one or both, as applicable) X 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 {26}------------------------------------------------ 510(k) Number (if known) K800894 Device Name DEPUY CEMENT RESTRICTOR #### Indications for Use (Describe) The UHMWPe cement restrictor is intended for use in cemented total and hemiarthroplasty procedures to restrict distal flow of bone cement in the femoral medullary cavity. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------|--------------------------------------------------------------| | <span style="text-decoration: underline;"><b></b></span> | <span style="text-decoration: underline;"><b></b></span> | | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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 {27}------------------------------------------------ 510(k) Number (if known) K871510 Device Name DEPUY MODIFIED PROFILE HIP PMMA CEMENT SPACER Indications for Use (Describe) The Modified Profile Hip PMMA Spacer is indicated for use in cemented hip replacement. | Type of Use (Select one or both, as applicable) | |--------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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 {28}------------------------------------------------ #### 510(k) Number (if known) K963206, K951000 Device Name DEPUY S-ROM HIP SYSTEM LOCKING PLUG, S-ROM SCREWS Indications for Use (Describe) Total hip arthroplasty is indicated for total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. 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. {29}------------------------------------------------ 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 {30}------------------------------------------------ # 510k Summaries {31}------------------------------------------------ # HIP STEMS 510k Summaries {32}------------------------------------------------ | Submitter Information | | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | DePuy Ireland UC | | Address | Loughbeg<br>Ringaskiddy<br>Co. Cork<br>Ireland | | Phone number | (+44) 7834974433 | | Fax number | N/A | | Establishment Registration Number | 3015516266 | | Name of contact person | Jennifer Hill | | Date prepared | 13th December 2023 | | Name of device | | | Trade or proprietary name | C-STEM™ System<br>C-STEM™ AMT Hip Prosthesis<br>CORAIL™ Revision Hip Prosthesis<br>S-ROM™ Femoral Total Hip System<br>S-ROM™ Total Hip System<br>S-ROM™ Coated ZT Proximal Hip System<br>S-ROM™ Femoral Hip Stem (Sizes 12x06x115 & 12x07x115)<br>Tri-Lock Bone Preservation Stem | | Common or usual name | Total Hip Joint Replacement Prosthesis | {33}------------------------------------------------ | | Uncemented Hip Prosthesis | |---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Femoral Prosthesis | | | Porous Coated Hip Prosthesis | | Classification name | 21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis. | | | 21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis. | | | 21 CFR 888.3358: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. | | | 21 CFR 888.3360: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis. | | | 21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. | | Class | II | | Classification panel | 87 Orthopedics | | Regulation | Class II - 21 CFR 888.3350 | | | Class II - 21 CFR 888.3353 | | | Class II - 21 CFR 888.3358 | | | Class II - 21 CFR 888.3360 | | | Class II - 21 CFR 888.3390 | | Product Code(s) | JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | | | LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | | | LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous uncemented | | | MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium Phosphate | | | KWL: Prosthesis, Hip, Hemi-, Femoral, Metal | | | KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | | | LWJ: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | | Legally marketed device(s) to which<br>equivalence is claimed | Primary Predicate – K102080 – RECLAIM™ Revision Hip System | | | K982918/K013350 - DePuy C-STEM™ System…
Innolitics

Panel 1

/
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...