510(k) · Cleared
ClearedSmith & Nephew Competitor Deuce Femoral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 6, 2006 as substantially equivalent to K042896 (Smith & Nephew, Inc., 2005) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Jul 6, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- NPJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K962137 (1996). 8 ancestors in all, the oldest K951987 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK962137 Genesis II Constrained SystemSmith & Nephew Richards, Inc. · 1996 · Recalled
- 3 generations backK041106 Revision Knee SystemSmith & Nephew, Inc. · 2004 · Recalled
- 2 generations backK043440 Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. · 2005 · Recalled
- 1 generation backK052265 Smith & Nephew Competitor Duo Knee FemoralSmith & Nephew, Inc. · 2005 · Recalled
- This deviceK061569 Smith & Nephew Competitor Deuce Femoral ComponentsSmith & Nephew, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK113038 Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee…Smith & Nephew, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K113038Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System InstrumentsSmith & Nephew, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962137 | Genesis II Constrained System | Smith & Nephew Richards, Inc. | 1996 | 1 |
| −3 | K041106 | Revision Knee System | Smith & Nephew, Inc. | 2004 | 1 |
| −2 | K043440 | Smith & Nephew, Inc. Revision Knee System | Smith & Nephew, Inc. | 2005 | 7 |
| −1 | K052265 | Smith & Nephew Competitor Duo Knee Femoral | Smith & Nephew, Inc. | 2005 | 42 |
| 0 (this device) | K061569 | Smith & Nephew Competitor Deuce Femoral Components | Smith & Nephew, Inc. | 2006 | — |
| +1 | K113038 | Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System… | Smith & Nephew, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NPJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042896 | Smith & Nephew Hybrid Knee FemoralSummary page 1…The overall design of the Competitor Deuce femoral components is based upon the existing Hybrid Knee femoral components and Competitor Duo femoral components subject of K042896 and K052265, respectively. Device Classification 21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-co… | 2005 |
| * | K052265 | Smith & Nephew Competitor Duo Knee FemoralSummary page 1…esign of the Competitor Deuce femoral components is based upon the existing Hybrid Knee femoral components and Competitor Duo femoral components subject of K042896 and K052265, respectively. Device Classification 21 CFR 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cem… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113038 | Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee System Instruments | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K113038 (Smith & Nephew, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K042896.
How does its category compare?
All NPJ devicesNPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NPJ
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · NPJ
76in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPJ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPJ
47in 2025
MAUDE reports naming product code NPJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 3 | 76 | 0 | 3 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 1 | 32 |
| 2012 | 0 | — | 0 | 72 |
| 2013 | 1 | — | 0 | 98 |
| 2014 | 0 | — | 0 | 75 |
| 2015 | 1 | — | 3 | 55 |
| 2016 | 0 | — | 1 | 93 |
| 2017 | 0 | — | 0 | 150 |
| 2018 | 0 | — | 0 | 141 |
| 2019 | 0 | — | 0 | 91 |
| 2020 | 0 | — | 0 | 65 |
| 2021 | 0 | — | 0 | 51 |
| 2022 | 0 | — | 0 | 32 |
| 2023 | 0 | — | 0 | 52 |
| 2024 | 0 | — | 0 | 44 |
| 2025 | 0 | — | 0 | 47 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Competitor Deuce 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 Deuce…
Read the full statement (100 words)
The Competitor Deuce 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 Deuce femoral components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.
The Competitor Deuce femoral components are single use only and are intended for implantation only with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061569 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061569: Smith & Nephew Competitor Deuce Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061569
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026