KWYClass II

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

21 CFR 888.3390 / Orthopedic

KWY is the FDA product code for Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a class II device type, regulated under 21 CFR 888.3390. As of 2026-09-10, FDA records hold 99 510(k) clearances under this code, the most recent dated 2026-04-13, and 88 recalls.

Classification record

Product code: KWY
Device name: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Regulation: 21 CFR 888.3390
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: 99
Ingested recalls: 88

Clearances, product code KWY

By decision year

99 clearances under product code KWY with a decision year between 1978 and 2026, 1996 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code KWY by decision year
Year	Clearances
1978	1
1979	1
1981	2
1983	3
1984	3
1985	1
1986	5
1987	3
1988	2
1989	3
1990	4
1991	2
1992	1
1993	2
1994	5
1995	5
1996	6
1997	2
1998	5
1999	1
2000	1
2001	2
2002	1
2003	1
2004	1
2005	3
2006	2
2008	3
2009	1
2010	4
2011	1
2012	1
2013	2
2014	1
2015	1
2016	1
2017	1
2018	3
2019	5
2020	1
2022	2
2023	2
2025	1
2026	1

Applicants with the most clearances

Product code KWY

Applicants holding the most 510(k) clearances under product code KWY
Applicant	Clearances
Zimmer GmbH	10
Johnson & Johnson Professionals, Inc.	9
Ortho Development Corp.	5
Howmedica Corp.	4
3M Company	3
Exactech, Inc.	3
Intermedics Orthopedics	3
Kirschner Medical Corp.	3
United Orthopedic Corp.	3
Biopro, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 178 companies shown, in name order