510(k) · Cleared

Recalled · Class II · 2017

Apex Knee System

K060192510(k) TraditionalCleared Jun 15, 2006141-day reviewClass II21 CFR 888.3560Recalls 1

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

Omni Life Science, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jun 15, 2006 as substantially equivalent to K943462 (Johnson & Johnson Professionals, Inc., 1994) and 3 other predicates after a 141-day review. Its family tree reaches back 1 generation to 1994. 111 later devices descend from it. It has been recalled once.

Decided: Jun 15, 2006
Review: 141 days
Class: Class II
Product code: JWH
Recalls: 1
Predicates: 4

Its longest line of descent runs back 1 generation to K943462 (1994). 4 ancestors in all. 111 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
This deviceK060192 Apex Knee SystemOmni Life Science, Inc. · 2006
Descendant · cites it directly · 72 of its ownK073602 Modification to: Apex Knee SystemOmnlife Science · 2008
Descendant · cites it directly · 61 of its ownK080842 Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008
Descendant · 2 generations on · 60 of its ownK131353 Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013
Descendant · cites it directly · 33 of its ownK112906 Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012
Descendant · 2 generations on · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014

Showing 5 of 111 descendants. See all descendants

Descendants cleared per year

2008high 16 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 111 · See all

K073602Modification to: Apex Knee SystemOmnlife Science · 2008 · cites it directly72descendants
K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc. · 2008 · cites it directly61descendants
K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp · 2013 · 2 generations on60descendants
K112906Klassic Knee SystemTotal Joint Orthopedics, Inc. · 2012 · cites it directly33descendants
K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · 2 generations on27descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943462	Darwin Knee System	Johnson & Johnson Professionals, Inc.	1994	8
0 (this device)	K060192	Apex Knee System	Omni Life Science, Inc.	2006	—
+1	K073602	Modification to: Apex Knee System	Omnlife Science	2008	—
+1	K080842	Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]	Omni Life Science, Inc.	2008	—
+2	K131353	Comprehensive Reverse Shoulder - Titanium Glenosphere	Biomet Manufacturing Corp	2013	—
+1	K112906	Klassic Knee System	Total Joint Orthopedics, Inc.	2012	—
+2	K140942	Klassic Knee Tibial Stem Extension	Total Joint Orthopedics, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2010	2	0
2011	3	0
2012	2	0
2013	2	0
2014	2	0
2015	5	0
2016	2	0
2017	1	0
2018	3	0
2019	7	0
2020	6	0
2021	12	0
2022	10	0
2023	16	0
2024	9	0
2025	12	0
2026	15	0

FIG. 1 — Lineage of K060192, 1994–2026Source: 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 JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JWH device

#1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (4)

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
*	K943462	Darwin Knee System Summary page 2 …and these predicate devices: Apex Knee P.F.C. Sigma t Natural-Knee I1* (K943462, K961685 (K973412, K021578) INTENDED USE - -; . s Primar…	Johnson & Johnson Professionals, Inc.	1994	8
*	K961685	P.F.C. Cruciate Retaining Knee System (Size 1.5) Summary page 2 …predicate devices: Apex Knee P.F.C. Sigma t Natural-Knee I1* (K943462, K961685 (K973412, K021578) INTENDED USE - -; . s Primary and rev…	Johnson & Johnson Professionals, Inc.	1996	7
*	K973412	Natural-Knee II Constrained Knee System Summary page 2 …vices: Apex Knee P.F.C. Sigma t Natural-Knee I1* (K943462, K961685 (K973412, K021578) INTENDED USE - -; . s Primary and revision, 3…	Sulzer Orthopedics, Inc.	1997	2
*	K021578	Natural-Knee II System Cocr Tibial Baseplate Summary page 2 …Apex Knee P.F.C. Sigma t Natural-Knee I1* (K943462, K961685 (K973412, K021578) INTENDED USE - -; . s Primary and revision, 3 Ye…	Sulzer Orthopedics, Inc.	2002	—

Also cleared against K943462: 11 other devices →

What descends from it? (111)

See all 111

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

Number	Device	Applicant	Decided	Descendants
K073602	Modification to: Apex Knee System	Omnlife Science	2008	72
K080842	Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]	Omni Life Science, Inc.	2008	61
K112906	Klassic Knee System	Total Joint Orthopedics, Inc.	2012	33
K102578	Apex PS Knee System	Omni Life Science, Inc.	2011	8
K094017	Tibial Baseplate Augment Model KC-22118, KC-22128, KC-22138, KC-22148, KC-22158	Omni Life Science, Inc.	2010	7
K101994	Apex Knee Modular Tibia System	Omnlife Science	2010	6
K112891	Apex Revision Knee Systems	Omni Life Science, Inc.	2012	5
K201611	Apex Knee System	Omnilife Science	2021	0
K111062	Apex Knee System, Apex All Poly Tibia	Omni Life Science, Inc.	2011	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 20, 2017	Class II	Z-1117-2018	Incorrect or no expiration date	The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The correct lot number (2022-03) is…

No ancestor or descendant has a Class I recall.

What does this lineage say?

3 of the 4 ancestors have a recall of any class.
Of its descendants, K073602 (Omnlife Science, 2008) has gone furthest, with 72 descendants of its own.
11 other devices also cite its predicate K943462.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWH

20in 2025

2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007high 168 (2009) · low 55 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JWH

2in 2025

2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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	18	74	14	1,305
2008	17	81	10	1,483
2009	11	168	109	1,870
2010	19	85	32	3,286
2011	25	87	27	5,133
2012	33	85	85	5,203
2013	31	128	31	6,135
2014	33	98	13	6,722
2015	27	87	11	6,881
2016	18	88	17	7,586
2017	25	118	61	12,263
2018	25	90	14	14,071
2019	28	133	5	14,987
2020	22	59	2	12,592
2021	24	61	8	9,408
2022	17	56	12	8,364
2023	20	57	67	8,947
2024	19	89	7	10,828
2025	20	55	2	9,306
2026	12	63	4	—

What is it indicated for?

The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate:

* Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

* Rheurmatoid arthritis;

* Correction of functional deformity;

* Revision procedures where other treatments or devices have failed.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060192 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060192: Apex Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060192

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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