510(k) · Cleared

Recalled · Class II · 2017

Total Knee Arthroplasty System

K150496510(k) TraditionalCleared Jun 12, 2015107-day reviewClass II21 CFR 888.3560Recalls 12

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

Responsive Orthopedics, LLC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jun 12, 2015 as substantially equivalent to K943462 (Johnson & Johnson Professionals, Inc., 1994) and 5 other predicates after a 107-day review. Its family tree reaches back 2 generations to 1994. It has been recalled 12 times.

Decided: Jun 12, 2015
Review: 107 days
Class: Class II
Product code: JWH
Recalls: 12
Predicates: 6

Its longest line of descent runs back 2 generations to K943462 (1994). 6 ancestors in all, the oldest K932837 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
1 generation backK032151 Depuy Sigma Tibial Inserts and CO-CR Tibial TraysDepuy, Inc. · 2003 · Recalled
This deviceK150496 Total Knee Arthroplasty SystemResponsive Orthopedics, LLC · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K943462	Darwin Knee System	Johnson & Johnson Professionals, Inc.	1994	8
−1	K032151	Depuy Sigma Tibial Inserts and CO-CR Tibial Trays	Depuy, Inc.	2003	12
0 (this device)	K150496	Total Knee Arthroplasty System	Responsive Orthopedics, LLC	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	1	0
1996	1	0
2010	1	0

FIG. 1 — Lineage of K150496, 1994–2015Source: 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

Get a 510(k) Report

What was it cleared against? (6)

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 4 …sign, performance, material, and intended use. The predicate devices for the Responsive Orthopedics Total Knee Arthroplasty System are: DePuy Sigma® Knee System (K943462, K961685, K032151, K950010) Wright Medical Technology EVOLUTION™ Medial Pivot (K093552) Consensus Knee System (K932…	Johnson & Johnson Professionals, Inc.	1994	8
*	K961685	P.F.C. Cruciate Retaining Knee System (Size 1.5) Summary page 4 …formance, material, and intended use. The predicate devices for the Responsive Orthopedics Total Knee Arthroplasty System are: DePuy Sigma® Knee System (K943462, K961685, K032151, K950010) Wright Medical Technology EVOLUTION™ Medial Pivot (K093552) Consensus Knee System (K932837) DEV…	Johnson & Johnson Professionals, Inc.	1996	7
*	K032151	Depuy Sigma Tibial Inserts and CO-CR Tibial Trays Summary page 4 …material, and intended use. The predicate devices for the Responsive Orthopedics Total Knee Arthroplasty System are: DePuy Sigma® Knee System (K943462, K961685, K032151, K950010) Wright Medical Technology EVOLUTION™ Medial Pivot (K093552) Consensus Knee System (K932837) DEVICE DESCR…	Depuy, Inc.	2003	12
*	K950010	Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated Summary page 4 …, and intended use. The predicate devices for the Responsive Orthopedics Total Knee Arthroplasty System are: DePuy Sigma® Knee System (K943462, K961685, K032151, K950010) Wright Medical Technology EVOLUTION™ Medial Pivot (K093552) Consensus Knee System (K932837) DEVICE DESCRIPTION: T…	Johnson & Johnson Professionals, Inc.	1995	16
*	K093552	Evolution MP Total Knee System Summary page 4 …edics Total Knee Arthroplasty System are: DePuy Sigma® Knee System (K943462, K961685, K032151, K950010) Wright Medical Technology EVOLUTION™ Medial Pivot (K093552) Consensus Knee System (K932837) DEVICE DESCRIPTION: The Responsive Orthopedics Total Knee Arthroplasty System is a total…	Wrightmedicaltechnologyinc	2010	5
*	K932837	Consensus Knee System - Primary Knee Summary page 4 …e: DePuy Sigma® Knee System (K943462, K961685, K032151, K950010) Wright Medical Technology EVOLUTION™ Medial Pivot (K093552) Consensus Knee System (K932837) DEVICE DESCRIPTION: The Responsive Orthopedics Total Knee Arthroplasty System is a total knee system for the restoration of ali…	U.S. Medical Products, Inc.	1994	—

Also cleared against K943462: 11 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 20, 2017	Class II	Z-1515-2017	Under Investigation by firm	The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Feb 20, 2017	Class II	Z-1513-2017	Under Investigation by firm	The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Feb 20, 2017	Class II	Z-1516-2017	Under Investigation by firm	The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Feb 20, 2017	Class II	Z-1514-2017	Under Investigation by firm	The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Jul 18, 2016	Class II	Z-2636-2016	Employee error	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Class II	Z-2637-2016	Employee error	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Class II	Z-2635-2016	Employee error	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Class II	Z-2634-2016	Employee error	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Class II	Z-2631-2016	Employee error	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Class II	Z-2638-2016	Employee error	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Class II	Z-2633-2016	Employee error	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Class II	Z-2632-2016	Employee error	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

The 5 latest of 12 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 21 years and passes through 3 companies; a new generation was cleared every 11.7 years on median.
5 of the 6 ancestors have a recall of any class.
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. 2015, this device’s year, is highlighted.

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 Responsive Orthopedics Total Knee Arthroplasty System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;

inflammatory degenerative joint disease including rheumatoid arthritis;

correction of functional deformity;

revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The Responsive Orthopedics Total Knee Arthroplasty System is for cemented use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K150496 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150496: Total Knee Arthroplasty System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150496

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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