KWLClass II

Prosthesis, Hip, Hemi-, Femoral, Metal

21 CFR 888.3360 / Orthopedic

KWL is the FDA product code for Prosthesis, Hip, Hemi-, Femoral, Metal, a class II device type, regulated under 21 CFR 888.3360. As of 2026-09-10, FDA records hold 108 510(k) clearances under this code, the most recent dated 2026-07-24, and 50 recalls.

Classification record

Product code: KWL
Device name: Prosthesis, Hip, Hemi-, Femoral, Metal
Regulation: 21 CFR 888.3360
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: 108
Ingested recalls: 51

Clearances, product code KWL

By decision year

108 clearances under product code KWL with a decision year between 1979 and 2026, 1985 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code KWL by decision year
Year	Clearances
1979	1
1980	1
1981	3
1982	5
1983	3
1984	6
1985	10
1986	2
1987	6
1988	2
1989	5
1990	9
1991	2
1992	4
1993	3
1994	4
1995	5
1996	3
1997	3
1998	2
1999	4
2002	1
2003	2
2004	1
2005	1
2006	2
2007	2
2008	1
2011	2
2012	1
2015	1
2018	2
2019	1
2020	1
2022	1
2024	1
2025	3
2026	2

Applicants with the most clearances

Product code KWL

Applicants holding the most 510(k) clearances under product code KWL
Applicant	Clearances
Zimmer GmbH	8
Osteonics Corp.	8
Depuy, Inc.	6
Osteoremedies, LLC	6
Howmedica Corp.	5
Orthomet, Inc.	4
Howmedica Osteonics Corp	3
Intermedics Orthopedics	3
Johnson & Johnson Professionals, Inc.	3
Mecron Medical Products, Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 119 companies shown, in name order