Who is the manufacturer of Smith & Nephew, Inc. R3™ Constrained Liner?

Smith & Nephew, Inc. filed the 510(k) submission for Smith & Nephew, Inc. R3™ Constrained Liner (K162641).

What is the FDA product code for Smith & Nephew, Inc. R3™ Constrained Liner?

KWZ. It is classified under 21 CFR 888.3310 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Smith & Nephew, Inc. R3™ Constrained Liner?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Smith & Nephew, Inc. R3™ Constrained Liner?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Smith & Nephew, Inc. R3™ Constrained Liner

Q: What are the predicate devices for Smith & Nephew, Inc. R3™ Constrained Liner?

R3 Constrained Liner (K111635); R3 Constrained Liners (K122139); REFLECTION Constrained Liners (K021803, K033442); R3 XLPE Liners (K113848); DePuy Self-Centering Hip Prostheses (K033273).

K162641 · Smith & Nephew, Inc. · KWZ · Jun 19, 2017 · Orthopedic

Device Facts

Record ID	K162641
Device Name	Smith & Nephew, Inc. R3™ Constrained Liner
Applicant	Smith & Nephew, Inc.
Product Code	KWZ · Orthopedic
Decision Date	Jun 19, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3310
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The R3™ Constrained Liner Acetabular System is an uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.

Device Story

R3 Constrained Liner Acetabular System is an uncemented hip prosthesis; provides stability for patients at high risk of dislocation. Device utilizes a tripolar design; consists of a bipolar bearing articulating with a captured outer polyethylene liner, locking ring, and outer poly support ring. Motion occurs at two interfaces: femoral head with bipolar bearing; bipolar bearing with outer liner. Subject device is a line extension of existing R3 Constrained Liners (K111635), adding new sizes (48mm, 50mm, 72-74mm, 76-80mm). Used in clinical settings by orthopedic surgeons during total hip arthroplasty. Output is a mechanical bearing surface; helps prevent hip dislocation; improves patient mobility; reduces pain. No software or AI components.

Clinical Evidence

Bench testing only. Mechanical testing conducted for attachment loads (push-in, pull-out, shuck-out, push-out) and dislocation resistance. Range of motion (ROM) evaluated. LAL testing performed for pyrogen limits (<= 20 EU/device). No clinical data required.

Technological Characteristics

Tripolar acetabular component; materials: UHMWPE, forged Titanium Alloy (Ti-6Al-4V), and Cobalt Chrome (CoCr). Sterilization: Ethylene Oxide. Design: Bipolar bearing, captured outer polyethylene liner, locking ring, outer poly support ring. Sizes: 48mm, 50mm, 72-74mm, 76-80mm.

Indications for Use

Indicated for primary or revision hip arthroplasty patients at high risk for dislocation due to prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability, where other constrained acetabular options have been considered.

Regulatory Classification

Identification

A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”

Predicate Devices

R3 Constrained Liner (K111635)
R3 Constrained Liners (K122139)
REFLECTION Constrained Liners (K021803, K033442)
R3 XLPE Liners (K113848)
DePuy Self-Centering Hip Prostheses (K033273)

Reference Devices

Osteonics Constrained Acetabular Inserts (P960047)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three overlapping profiles, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem. June 19, 2017 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Smith & Nephew, Inc. Dongeun Kim Regulatory Affairs Specialist I 7135 Goodlett Farms Parkway Cordova, Tennessee 38016 Re: K162641 Trade/Device Name: Smith & Nephew, Inc. R3TM Constrained Liner Regulation Number: 21 CFR 888.3310 Regulation Name: Hip Joint Metal/Polymer Constrained Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWZ Dated: May 18, 2017 Received: May 19, 2017 Dear Dongeun Kim: 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K162641 Device Name Smith & Nephew, Inc. R3TM Constrained Liner Indications for Use (Describe) The R3™ Constrained Liner Acetabular System is an uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only. 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 "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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the logo for Smith & Nephew. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The text "We are" is in gray, while "smith&nephew" is in orange, matching the color of the flower symbol. The logo is simple and clean, with a focus on the company name. | Submitted by: | Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116 | |----------------------------------------------|----------------------------------------------------------------------------------------------| | Date of Summary: | June 19, 2017 | | Contact Person and Address: | Dongeun Kim Regulatory Affairs Specialist I T 901-399-1151 F 901-566-7120 | | Name of Device: | Smith & Nephew, Inc. R3TM Constrained Liner | | Common Name: | Acetabular Liner, Constrained | | Device Classification Name and Reference: | 21 CFR 888.3310 Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis | | Device Class: | Class II | | Panel Code: | Orthopaedics/87 | | Product Code: | KWZ | #### Device Description Subject of this Traditional premarket notification is the addition of new liner sizes to the Smith & Nephew R3" Constrained Liner Acetabular System. The R3 Constrained Liner Acetabular System currently consists of the R3 Constrained Liner offered in sizes of 52mm to 66/70mm cleared via premarket notification K111635. The proposed devices are additional sizes to the R3 Constrained Liners that were previously cleared. The proposed devices will be offered in sizes of 48mm, 50mm, 72-74mm, and 76-80mm, and will be marketed as part of the R3 Constrained Liner Acetabular System. The new R3 Constrained Liner sizes are line additions to the primary predicate R3 Constrained Liners cleared via premarket notification K111635. The subject devices are similar to the primary predicate R3 Constrained Liners in that they are a multipiece acetabular component consisting of a bipolar bearing that articulates with a captured outer polyethylene liner, locking ring, and outer poly support ring. The subject devices and the primary predicate R3 Constrained Liners utilize a tripolar design allowing motion at two interfaces: the femoral head with the bipolar bearing and the bipolar bearing with the outer liner. The subject devices are identical in design to the cleared R3 Constrained Liners, with the exception that they are smaller or larger in overall size. The new R3 Constrained Liner sizes are also similar to the following additional predicates: R3 Constrained Liners (K122139), REFLECTION Constrained Liners (K021803, K033442), R3 XLPE Liners (K113848), and DePuy Self-Centering Hip Prostheses (K033273). The subject devices are also similar to reference predicate Osteonics Constrained Acetabular Inserts (P960047). The subject devices utilize seven components manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE), forged Titanium Alloy (Ti-6Al-4V), and Cobalt Chrome (CoCr). {4}------------------------------------------------ #### Intended Use The R3™ Constrained Liner Acetabular System is an uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation. bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only. ### Technological Characteristics Mechanical testing has been conducted for the subject devices to address the attachment loads (push-in, pull-out, shuck-out, and push-out) and dislocation resistance. The range of motion (ROM) has also been evaluated. A review of the testing has demonstrated that there are no new issues related to safety or effectiveness of the subject devices. Clinical data was not needed to support substantial equivalence. The Limulus Amebocyte Lysate (LAL) test was used to determine the subject devices meets the specified pyrogen limit specification of less than or equal to 20 EU/device. # Substantial Equivalence Information The intended use, indications for use, and technological characteristics of the subject R3 Constrained Liners are substantially equivalent to the predicate devices. A comparison of the subject devices to the predicate devices are provided in Table 5.1 below. {5}------------------------------------------------ | Design Features | Subject R3 Constrained Liner | 510(k) Number | Manufacturer | | Indications for Use/Intended Use | R3 Constrained Liner (Primary Predicate) | R3 Constrained Liner (Additional Predicate) | REFLECTION Constrained Liner (Additional Predicate) | R3 XLPE Liner (Additional Predicate) | DePuy Self-Centering Hip Prosthesis (Additional Predicate) | Osteonics Constrained Acetabular Insert (Reference Predicate) | | | | | | | | | | |-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------------------| | | The R3 Constrained Liner Acetabular System is an uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra- operative instability and for whom all other options to constrained acetabular components have | K111635 | Smith & Nephew, Inc. | The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra- operative instability and for whom all other options to constrained acetabular | | The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra- operative instability and for whom all other options to constrained acetabular | K122139 | Smith & Nephew, Inc. | The REFLECTION Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra' operative instability and for whom all other options to constrained | K021803, K033442 | Smith & Nephew, Inc. | 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 | K113848 | Smith & Nephew, Inc. | Indications for the UltimaTM Unipolar heads and the Self- CenteringTM Hip Prostheses previously cleared for Hemi-Hip Arthroplasty remain unchanged. Additions to the indications for use include: Self-CenteringTM Hip Prostheses and unipolar femoral heads are also intended to be used for total hip arthroplasty 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, when used in conjunction with a UHMWPE bearing surface having an inside | K033273 | DePuy Orthopaedics, Inc. | The Osteonics Constrained Acetabular Insert is indicated as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. | P960047 | Howmedica Osteonics Corp. | ਣ のない 이후 പ് d Liner to the Constrainc rs ണ്ട ട് ത ਾਪੂ: rison of t .. ﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ hle 5-3 {6}------------------------------------------------ | K162641 | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|-----------------------------|----------------| | | Size Offering (Outer Diameter) | Materials | Sterilization | | Constrained Liner is intended for single use only. The R3 components have been considered. | 48mm, 50mm, 72- 74mm, and 76- 80mm | UHMWPE, Ti-6Al- 4V, CoCr | Ethylene Oxide | | Constrained Liner is intended for single use only. The R3 components have been considered. | 52mm to 66/70mm | UHMWPE, Ti-6Al- 4V, CoCr | Ethylene Oxide | | Constrained Liner is intended for single use only. The R3 components have been considered. | 52mm to 66/70mm | UHMWPE, Ti-6Al- 4V, CoCr | Ethylene Oxide | | acetabular components have been considered. | 46/48mm- 70/76mm | UHMWPE, Ti-6Al- 4V, CoCr | Ethylene Oxide | | 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. | 22mm-36mm | XLPE | Ethylene Oxide | | diameter corresponding to outside diameter of the metallic cup that is utilized. Use in total hip replacement is indicated in the following additional conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia 2. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, or total hip replacement. | 39mm-57mm | UHMWPE | | | | 50mm-74mm | UHMWPE, Ti- 6Al-4V, CoCr | | Page 4 of 5 5-4 {7}------------------------------------------------ # Conclusion This Traditional 510(k) Premarket Notification is being submitted to request clearance for the new R3 Constrained Liner sizes of 48mm, 50mm, 72mm-74mm, and 76mm-80mm. Based on the similarities to the predicate devices and a review of the mechanical testing performed, the subject devices are substantially equivalent to the above predicate devices.

Smith & Nephew, Inc. R3™ Constrained Liner

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Smith & Nephew, Inc. R3™ Constrained Liner

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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