HWCClass II

Screw, Fixation, Bone

21 CFR 888.3040 / Orthopedic

HWC is the FDA product code for Screw, Fixation, Bone, a class II device type, regulated under 21 CFR 888.3040. As of 2026-09-10, FDA records hold 1,064 510(k) clearances under this code, the most recent dated 2026-08-24, and 388 recalls.

Classification record

Product code: HWC
Device name: Screw, Fixation, Bone
Regulation: 21 CFR 888.3040
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: 1,068
Ingested recalls: 388

Clearances, product code HWC

By decision year

1,068 clearances under product code HWC with a decision year between 1977 and 2026, 2004 the highest year at 46.

Show the numbers

510(k) clearances under FDA product code HWC by decision year
Year	Clearances
1977	1
1978	1
1979	2
1981	2
1983	1
1985	7
1986	7
1987	10
1988	7
1989	13
1990	13
1991	14
1992	11
1993	10
1994	35
1995	36
1996	32
1997	20
1998	26
1999	29
2000	13
2001	39
2002	42
2003	33
2004	46
2005	35
2006	42
2007	35
2008	33
2009	27
2010	23
2011	35
2012	20
2013	25
2014	31
2015	41
2016	26
2017	40
2018	20
2019	30
2020	28
2021	26
2022	26
2023	24
2024	17
2025	15
2026	19

Applicants with the most clearances

Product code HWC

Applicants holding the most 510(k) clearances under product code HWC
Applicant	Clearances
Arthrex GmbH	46
Zimmer GmbH	36
Synthes (USA) Products LLC	36
Wrightmedicaltechnologyinc	31
Smith & Nephew, Inc.	29
Linvatec Corporation	17
Medartis AG	17
Extremity Medical, LLC	16
DePuy Mitek, Inc.	15
Osteomed	15

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 571 companies shown, in name order