JWHClass II

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

21 CFR 888.3560 / Orthopedic

JWH is the FDA product code for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a class II device type, regulated under 21 CFR 888.3560. As of 2026-09-10, FDA records hold 915 510(k) clearances under this code, the most recent dated 2026-08-07, and 983 recalls.

Classification record

Product code: JWH
Device name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation: 21 CFR 888.3560
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 921
Ingested recalls: 984

Clearances, product code JWH

By decision year

921 clearances under product code JWH with a decision year between 1976 and 2026, 1994 the highest year at 38.

Show the numbers

510(k) clearances under FDA product code JWH by decision year
Year	Clearances
1976	1
1977	2
1978	1
1979	1
1980	2
1981	2
1982	1
1983	3
1984	6
1985	4
1986	9
1987	18
1988	8
1989	16
1990	22
1991	23
1992	22
1993	25
1994	38
1995	32
1996	32
1997	27
1998	21
1999	21
2000	20
2001	21
2002	25
2003	21
2004	21
2005	16
2006	16
2007	18
2008	17
2009	11
2010	19
2011	25
2012	33
2013	31
2014	33
2015	27
2016	18
2017	25
2018	25
2019	28
2020	22
2021	24
2022	17
2023	20
2024	19
2025	20
2026	12

Applicants with the most clearances

Product code JWH

Applicants holding the most 510(k) clearances under product code JWH
Applicant	Clearances
Zimmer GmbH	91
Smith & Nephew, Inc.	49
Howmedica Corp.	47
ConforMIS, Inc.	40
Exactech, Inc.	32
Howmedica Osteonics Corp	32
Depuy, Inc.	27
Medacta International SA	27
Dow Corning Wright	24
Osteonics Corp.	24

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 266 companies shown, in name order