# K042515: Smith & Nephew, Inc. High Performance Knee

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 14, 2005 after 179 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951987 (1995). 3 ancestors in all.
118 later devices descend from it; 12 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 1.
- K962557: Genesis II Zirconium  Femoral Component/Profix Zirconium Femoral Component, Smith & Nephew Richards, Inc. (1996) Summary page 1.
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO, Zimmer, Inc. (1999) Summary page 1.

## Most influential descendants
- K071071: Crosslinked Polyethylene Articular Inserts (2007), 66 descendants of its own
- K101499: Journey CR Knee System (2010), 45 descendants of its own
- K094050: Itotal CR Knee Replacement System (2010), 41 descendants of its own
- K091014: Journey BCS Knee System (2009), 41 descendants of its own
- K111711: Journey II BCS Knee System (2011), 40 descendants of its own

## Recalls of this device
- Jun 13, 2018 · Class II · Z-0001-2019: The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first ge
- Jun 13, 2018 · Class II · Z-0002-2019: The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first ge
- Jun 13, 2018 · Class II · Z-0003-2019: The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first ge

## Indications for use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. 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. Smith & Nephew, Inc. High Performance Knee components are indicated for use only with cement and are single use devices.

Source page: https://510kreport.com/device/K042515
Methodology: https://510kreport.com/methodology