FDA product code · Orthopedic

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Name: FDA decisions, review times, recalls and adverse event reports for product code JWH
Creator: 510(k) Report

JWHClass II21 CFR 888.3560510(k) required921 decisions since 1976665 recalls

921 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 60 days (half between 29 and 94). 665 recalls name this code, 0 of them Class I. The most-cited predicate is K951987, named by 32 later devices.

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

FIG. A — Illustration, orthopedic panel

Twenty years of JWH at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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	—

FIG. 1 — JWH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JWH? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do JWH devices cite most?

Devices in this code that later submissions most often claim equivalence to.

K951987Genesis II Total Knee SystemSmith & Nephew Richards, Inc. · 199532cite it
K991581Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and…Zimmer, Inc. · 199919cite it
K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp · 201218cite it
K090988GMK Total Knee SystemMedacta International S.A. · 200918cite it
K040267Triathlon Cruciate Retaining (CR) Total KneeHowmedica Osteonics Corp. · 200417cite it
K113369Zimmer Persona Knee SystemZimmer, Inc. · 201217cite it

Which JWH devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc. · 202324generations
K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc. · 202324generations
K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) InsertConformis, Inc. · 202324generations
K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and…Conformis, Inc. · 202223generations
K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and…Conformis, Inc. · 202222generations
K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized…Conformis, Inc. · 202121generations

What has FDA decided in JWH lately?

K262057GMK ExtensionMedacta International SA · 2026
K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026
K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd. · 2026

All 921 JWH decisions →

What has been recalled in JWH lately?

K243817All Poly Constrained Insert 54MM 69-2854 NRG Knee CR 82-2-0512 82-2-0518 82-2-0912 NRG…Howmedica Osteonics Corp. · Jul 30, 2026Class II
K082424Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial…United Orthopedic Corp. · May 20, 2026Class II
K143242Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog…Encore Medical, LP · Feb 16, 2026Class II
K143242Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog…Encore Medical, LP · Feb 16, 2026Class II
K960279NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14…Zimmer, Inc. · Jan 6, 2025Class II
K960279NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10…Zimmer, Inc. · Jan 6, 2025Class II

Related product codes

Other codes under 21 CFR 888.3560.

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