← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K071071 # CROSSLINKED POLYETHYLENE ARTICULAR INSERTS (K071071) _Smith & Nephew, Inc. · JWH · Sep 19, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K071071 ## Device Facts - **Applicant:** Smith & Nephew, Inc. - **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md) - **Decision Date:** Sep 19, 2007 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 888.3560 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Total Knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis for use in primary and revision surgeries. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Constrained Knee Systems are designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the colateral ligaments (i.e. medial cruciate ligament and one or both of the collateral ligaments) are absent or inadequate. Smith & Nephew, Inc. Crosslinked Polyethylene Articular Inserts are single use devices. The indications for each device system are identical to the indications for each cleared predicate knee system ## Device Story Crosslinked Polyethylene Articular Inserts are orthopedic components for knee replacement systems (Journey and Genesis II). These inserts are fabricated from Ultra High Molecular Weight Polyethylene (UHMWPE) subjected to a proprietary crosslinking process to enhance wear resistance compared to conventional UHMWPE. The devices are intended for single use in primary or revision knee arthroplasty. They function as the bearing surface within the knee joint prosthesis, replacing damaged cartilage to restore joint function and reduce pain. The inserts are implanted by orthopedic surgeons during surgical procedures. The design and function remain consistent with previously cleared non-crosslinked counterparts, providing the same clinical utility while offering improved material durability. ## Clinical Evidence No clinical data provided; substantial equivalence is based on design, material, and functional similarity to predicate devices. ## Technological Characteristics Material: Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE). Form factor: Articular inserts for knee joint prostheses. Principle: Bearing surface for semi-constrained cemented or uncemented knee arthroplasty. Sterilization: Not specified. ## Regulatory Identification A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - Genesis II Knee System (cemented use) ([K951987](/device/K951987.md)) - Genesis II Knee System (uncemented use) ([K030612](/device/K030612.md)) - Genesis II Constrained Knee System ([K962137](/device/K962137.md)) - Genesis II High Flex PS Articular Inserts ([K032295](/device/K032295.md)) - Genesis II Deep Flex CR Articular Inserts ([K041825](/device/K041825.md)) - High Performance Knee (Journey BCS) ([K042515](/device/K042515.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K07107/ page 142 Smith & Nephew, Inc. Summary of Safety and Effectiveness Crosslinked Polyethylene Articular Inserts SEP 1 9 2007 #### Contact Person and Address Date of Summary: 04/12/2007 Rishi Sinha Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Reconstruction 1450 Brooks Road Memphis, TN 38116 (901)399-6054 Name of Device: Crosslinked Polyethylene Articular Inserts Common Name: Articular Inserts ### Device Description The intended use, base material, and design specifications of the Smith & Nephew Crosslinked Polyethylene articular inserts for the Journey and Genesis II knee systems are the same as subject identical components fabricated from conventional non-Crosslinked Ultra High Molecular Weight Polyethylene. The devices subject to this premarket notification have been Crosslinked by a proprietary process. As a result, the polymer is highly crosstinked with increased wear performance properties over traditional UHMWPE. ### Device Classification 21 CFR 888.3560 Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis - Class II 21 CFR 888.3565 Knee joint patellofemorotibial polymer semi-constrained uncemented prosthesis - Class II ### Indications for Use Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis for use in primary and revision surgeries. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Constrained Knee Systems are designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the colateral ligaments (i.e. medial cruciate ligament and one or both of the collateral ligaments) are absent on inadequate. The indications for each device system are identical to the indications for each cleared predicate knee system. {1}------------------------------------------------ : # Substantial Equivalence Information The overall design and function of the Crosslinked components have not been changed over that of their identical counterparts manufactured from conventional UHMWPE listed in the table below | DESCRIPTION | 510(K) | CLEARANCE DATE | |-------------------------------------------|---------|----------------| | Genesis II Knee System (cemented use) | K951987 | 8/22/95 | | Genesis II Knee System (uncemented use) | K030612 | 5/27/03 | | Genesis II Constrained Knee System | K962137 | 8/2/96 | | Genesis II High Flex PS Articular Inserts | K032295 | 8/21/03 | | Genesis II Deep Flex CR Articular Inserts | K041825 | 3/11/05 | | High Performance Knee (Journey BCS) | K042515 | 3/14/05 | : : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Smith & Nephew, Inc. % Mr. Rishi Sinha Regulatory Affairs Specialist 1450 E. Brooks Road Memphis, Tennessee 38116 SEP 1 9 2007 Re: K071071 Trade/Device Name: Crosslinked Polyethylene Articular Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: August 24, 2007 Received: August 28, 2007 Dear Mr. Sinha: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Mr. Rishi Sinha This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Barbara Buchu Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K071071 Device Name: Crosslinked Polyethylene Articular Inserts Indications for Use: Total Knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis for use in primary and revision surgeries. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Constrained Knee Systems are designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the colateral ligaments (i.e. medial cruciate ligament and one or both of the collateral ligaments) are absent or inadequate. Smith & Nephew, Inc. Crosslinked Polyethylene Articular Inserts are single use devices. The indications for each device system are identical to the indications for each cleared predicate knee system Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Andrew Buehler (Division Sign-Off) Division of Gen and Neurological De Page 1 of _ **510(k) Number** K071071 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K071071](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K071071) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com