# K052265: Smith & Nephew Competitor Duo Knee Femoral

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 27, 2005 after 130 days
- Product code: NPJ (Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 42 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962137 (1996). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042896: Smith & Nephew Hybrid Knee Femoral, Smith & Nephew, Inc. (2005) Summary page 1.
- K962557: Genesis II Zirconium  Femoral Component/Profix Zirconium Femoral Component, Smith & Nephew Richards, Inc. (1996) Summary page 1.
- K043440: Smith & Nephew, Inc. Revision Knee System, Smith & Nephew, Inc. (2005) Summary page 1.

## Most influential descendants
- K061569: Smith & Nephew Competitor Deuce Femoral Components (2006), 1 descendant of its own
- K113038: Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System Instruments (2012), 0 descendants of its own

## Recalls of this device
- Jan 23, 2009 · Not classified · Z-0925-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0926-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0928-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0929-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0930-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0932-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0933-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0934-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0937-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0942-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0944-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0945-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0949-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0951-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0952-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0954-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0957-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0959-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0938-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0946-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0953-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0960-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0961-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0962-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0936-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0940-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0943-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0955-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0958-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0964-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0924-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0927-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0931-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0935-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0939-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0941-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0947-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0948-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0950-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0956-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0963-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili
- Jan 23, 2009 · Not classified · Z-0965-2010: The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instabili

## Indications for use
The Competitor Duo Knee Femoral Components are intended to be used for those patients whereby conditions exist that can not be solely addressed by a device that treats a single compartment (i.e. unicondylar or patellofemoral prosthesis) of the knee. Indications include: * post-traumatic arthritis; * degenerative arthritis; and * failed osteotomies, hemiarthroplasties; and unicompartmental replacement These indications will be used for the Competitor Duo Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions The Competitor Duo Knee Femoral Components are single use only and are intended for implantation only with bone cement

Source page: https://510kreport.com/device/K052265
Methodology: https://510kreport.com/methodology