510(k) · Cleared
Recalled · 2009Smith & Nephew Competitor Duo Knee Femoral
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 Dec 27, 2005 as substantially equivalent to K042896 (Smith & Nephew, Inc., 2005) and 2 other predicates after a 130-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it. It has been recalled 42 times.
- Decided
- Dec 27, 2005
- Review
- 130 days
- Class
- Class II
- Product code
- NPJ
- Recalls
- 42
- Predicates
- 3
Its longest line of descent runs back 3 generations to K962137 (1996). 7 ancestors in all, the oldest K951987 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK962137 Genesis II Constrained SystemSmith & Nephew Richards, Inc. · 1996 · Recalled
- 2 generations backK041106 Revision Knee SystemSmith & Nephew, Inc. · 2004 · Recalled
- 1 generation backK043440 Smith & Nephew, Inc. Revision Knee SystemSmith & Nephew, Inc. · 2005 · Recalled
- This deviceK052265 Smith & Nephew Competitor Duo Knee FemoralSmith & Nephew, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK061569 Smith & Nephew Competitor Deuce Femoral ComponentsSmith & Nephew, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK113038 Smith & Nephew Inc. Unicompartmental and Biocompartmental Knee…Smith & Nephew, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962137 | Genesis II Constrained System | Smith & Nephew Richards, Inc. | 1996 | 1 |
| −2 | K041106 | Revision Knee System | Smith & Nephew, Inc. | 2004 | 1 |
| −1 | K043440 | Smith & Nephew, Inc. Revision Knee System | Smith & Nephew, Inc. | 2005 | 7 |
| 0 (this device) | K052265 | Smith & Nephew Competitor Duo Knee Femoral | Smith & Nephew, Inc. | 2005 | — |
| +1 | K061569 | Smith & Nephew Competitor Deuce Femoral Components | Smith & Nephew, Inc. | 2006 | — |
| +2 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (3)
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 existing Hybrid designs of the Competitor Duo femoral component are based upon Femoral Component subject of K042896. C. SUBSTANTIAL EQUIVALENCE INFORMATION:… | 2005 |
| * | K962557 | Genesis II Zirconium Femoral Component/Profix Zirconium Femoral ComponentSummary page 1…K042896) K043440) • Genesis II and Legion (Revision) Knee Femorals (Oxinium Material) (K962557 and Public Health Se… | 1996 |
| * | K043440 | Smith & Nephew, Inc. Revision Knee SystemSummary page 1…s, overall indications, and materials: * Smith & Nephew Hybrid Knee Femoral (K042896) K043440) • Genesis II and Legion (Revision) Knee Femorals (Oxinium Material) (K962557 and… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061569 | Smith & Nephew Competitor Deuce Femoral Components | 2006 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 23, 2009 | Not classified | Z-0925-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0926-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0928-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0929-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0930-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0932-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0933-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0934-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0937-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0942-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0944-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0945-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0949-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0951-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0952-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0954-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0957-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0959-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0938-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0946-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0953-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0960-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0961-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0962-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0936-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0940-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0943-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0955-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0958-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0964-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0924-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0927-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0931-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0935-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0939-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0941-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0947-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0948-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0950-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0956-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0963-2010 | Device Design | 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 instability and premature wear of the construct. |
| Jan 23, 2009 | Not classified | Z-0965-2010 | Device Design | 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 instability and premature wear of the construct. |
The 5 latest of 42 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K061569 (Smith & Nephew, Inc., 2006) has gone furthest, with 1 descendant 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
2007high 3 (2009) · low 0 (2008)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · NPJ
76in 2009
2007high 76 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPJ
1in 2016
2007high 3 (2015) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPJ
47in 2025
2007high 150 (2017) · low 0 (2007)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 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…
Read the full statement (103 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052265 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052265: Smith & Nephew Competitor Duo Knee Femoral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052265
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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