HRSClass II

Plate, Fixation, Bone

21 CFR 888.3030 / Orthopedic

HRS is the FDA product code for Plate, Fixation, Bone, a class II device type, regulated under 21 CFR 888.3030. As of 2026-09-10, FDA records hold 1,323 510(k) clearances under this code, the most recent dated 2026-08-28, and 286 recalls.

Classification record

Product code: HRS
Device name: Plate, Fixation, Bone
Regulation: 21 CFR 888.3030
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: 1,327
Ingested recalls: 286

Clearances, product code HRS

By decision year

1,327 clearances under product code HRS with a decision year between 1976 and 2026, 2014 the highest year at 76.

Show the numbers

510(k) clearances under FDA product code HRS by decision year
Year	Clearances
1976	1
1977	1
1979	1
1980	3
1981	3
1983	1
1984	1
1985	6
1986	4
1987	4
1988	2
1989	4
1990	3
1991	14
1992	11
1993	5
1994	19
1995	14
1996	12
1997	19
1998	25
1999	12
2000	15
2001	17
2002	23
2003	21
2004	31
2005	43
2006	39
2007	35
2008	35
2009	47
2010	49
2011	43
2012	59
2013	56
2014	76
2015	56
2016	44
2017	57
2018	40
2019	46
2020	48
2021	40
2022	47
2023	40
2024	54
2025	54
2026	47

Applicants with the most clearances

Product code HRS

Applicants holding the most 510(k) clearances under product code HRS
Applicant	Clearances
Synthes (USA) Products LLC	110
Zimmer GmbH	54
Wrightmedicaltechnologyinc	45
Arthrex GmbH	39
Medartis AG	38
Smith & Nephew, Inc.	38
Howmedica Corp.	27
AAP Implantate AG	25
Newclip Technics	25
Stryker Corp.	25

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 462 companies shown, in name order