510(k) · Cleared

Cleared

Smith & Nephew Hybrid Knee Femoral

K042896510(k) AbbreviatedCleared Jan 12, 200584-day reviewClass II21 CFR 888.3560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smith & Nephew, Inc. · NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jan 12, 2005 after an 84-day review. The FDA summary names its predicate without a number. 39 later devices descend from it.

Decided: Jan 12, 2005
Review: 84 days
Class: Class II
Product code: NPJ
Recalls: None
Predicates: 0

39 later devices descend from it, 3 citing it directly.

This deviceK042896 Smith & Nephew Hybrid Knee FemoralSmith & Nephew, Inc. · 2005
Descendant · cites it directly · 35 of its ownK053488 Conformis Bicompartmental Knee Repair SystemConformis, Inc. · 2006
Descendant · 2 generations on · 32 of its ownK063432 Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · Recalled
Descendant · 2 generations on · 31 of its ownK072368 Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · Recalled
Descendant · 2 generations on · 30 of its ownK072586 Conformis Uni-Condylar Knee SystemConformis, Inc. · 2007
Descendant · 3 generations on · 29 of its ownK092441 Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2005high 9 (2021) · low 0 (2010)2026

Most influential descendants

Showing 5 of 39 · See all

K053488Conformis Bicompartmental Knee Repair SystemConformis, Inc. · 2006 · cites it directly35descendants
K063432Conformis Metal Backed Tibial Component (MBT)Conformis, Inc. · 2007 · 2 generations on32descendants
K072368Conformis Metal Backed Tibial ComponentConformis, Inc. · 2007 · 2 generations on31descendants
K072586Conformis Uni-Condylar Knee SystemConformis, Inc. · 2007 · 2 generations on30descendants
K092441Modification to: Conformis Iuni Unicondylar Knee Repair SystemConformis, Inc. · 2009 · 3 generations on29descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K042896	Smith & Nephew Hybrid Knee Femoral	Smith & Nephew, Inc.	2005	—
+1	K053488	Conformis Bicompartmental Knee Repair System	Conformis, Inc.	2006	—
+2	K063432	Conformis Metal Backed Tibial Component (MBT)	Conformis, Inc.	2007	3
+2	K072368	Conformis Metal Backed Tibial Component	Conformis, Inc.	2007	3
+2	K072586	Conformis Uni-Condylar Knee System	Conformis, Inc.	2007	—
+3	K092441	Modification to: Conformis Iuni Unicondylar Knee Repair System	Conformis, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2007	3	0
2008	1	0
2009	2	0
2011	1	0
2012	2	0
2013	1	0
2014	1	0
2017	1	0
2019	3	0
2020	3	0
2021	9	0
2022	2	0
2023	5	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K042896, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	—	Genesis I Unicondylar Knee System Named without a submission number			—
*	—	Genesis II Total Knee System Named without a submission number			—

What descends from it? (39)

See all 39

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K053488	Conformis Bicompartmental Knee Repair System	Conformis, Inc.	2006	35
K052265	Smith & Nephew Competitor Duo Knee Femoral	Smith & Nephew, Inc.	2005	2
K061569	Smith & Nephew Competitor Deuce Femoral Components	Smith & Nephew, Inc.	2006	1

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?

Of its descendants, K053488 (Conformis, Inc., 2006) has gone furthest, with 35 descendants of its own.

How does its category compare?

All NPJ devices

NPJ 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 Hybrid 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 Hybrid Knee Femoral Components, whereby the medial condyle and patellofemoral regions have been affected by one or more of these conditions.

The Hybrid 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/K042896 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042896: Smith & Nephew Hybrid 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/K042896

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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