JDRClass II

Staple, Fixation, Bone

21 CFR 888.3030 / Orthopedic

JDR is the FDA product code for Staple, Fixation, Bone, a class II device type, regulated under 21 CFR 888.3030. As of 2026-09-10, FDA records hold 232 510(k) clearances under this code, the most recent dated 2026-08-06, and 36 recalls.

Classification record

Product code: JDR
Device name: Staple, 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: 233
Ingested recalls: 37

Clearances, product code JDR

By decision year

233 clearances under product code JDR with a decision year between 1979 and 2026, 1995 the highest year at 17.

Show the numbers

510(k) clearances under FDA product code JDR by decision year
Year	Clearances
1979	1
1981	1
1982	2
1983	2
1984	1
1985	2
1986	2
1987	1
1988	1
1989	3
1990	14
1991	8
1992	4
1993	10
1994	10
1995	17
1996	7
1997	2
1998	2
1999	3
2000	3
2001	6
2002	5
2003	1
2004	6
2005	4
2006	13
2007	8
2008	5
2010	2
2011	1
2012	1
2013	9
2014	11
2015	7
2016	6
2017	9
2018	8
2019	5
2020	4
2021	3
2022	5
2023	9
2024	4
2025	3
2026	2

Applicants with the most clearances

Product code JDR

Applicants holding the most 510(k) clearances under product code JDR
Applicant	Clearances
Mitek Surgical Products, Inc.	16
DePuy Mitek, Inc.	11
Acufex Microsurgical, Inc.	9
Biomedical Ent., Inc.	6
Arthrex GmbH	5
Howmedica Corp.	5
Medartis AG	5
American Medical Electronics, Inc.	4
Arthrotek, Inc.	4
Biomedical Enterprises, Inc.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 204 companies shown, in name order