JDBClass II

Prosthesis, Elbow, Semi-Constrained, Cemented

21 CFR 888.3160 / Orthopedic

JDB is the FDA product code for Prosthesis, Elbow, Semi-Constrained, Cemented, a class II device type, regulated under 21 CFR 888.3160. As of 2026-09-10, FDA records hold 27 510(k) clearances under this code, the most recent dated 2022-10-26, and 26 recalls.

Classification record

Product code: JDB
Device name: Prosthesis, Elbow, Semi-Constrained, Cemented
Regulation: 21 CFR 888.3160
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: 27
Ingested recalls: 26

Clearances, product code JDB

By decision year

27 clearances under product code JDB with a decision year between 1980 and 2022, 1981 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code JDB by decision year
Year	Clearances
1980	2
1981	3
1982	2
1983	1
1988	2
1996	2
1997	1
1998	1
2001	1
2003	1
2005	1
2006	2
2007	2
2010	2
2017	1
2018	1
2020	1
2022	1

Applicants with the most clearances

Product code JDB

Applicants holding the most 510(k) clearances under product code JDB
Applicant	Clearances
TORNIER Inc.	9
Small Bone Innovations, Inc.	3
Zimmer GmbH	3
Depuy, Inc.	2
Howmedica Corp.	2
Johnson & Johnson Professionals, Inc.	2
Wrightmedicaltechnologyinc	2
Cintor Orthopaedic Div.	1
Depuy, Inc.	1
Lima Corporate S.p.A.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 37 companies shown, in name order