JDB · Class II · 21 CFR 888.3160

FDA Product Code JDB: Prosthesis, Elbow, Semi-constrained, Cemented

Leading manufacturers include Depuy, Inc., Tornier, Inc. and Zimmer, Inc..

27
Total
27
Cleared
96d
Avg days
1980
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Prosthesis, Elbow, Semi-constrained, Cemented Devices (Product Code JDB)

27 devices
1–24 of 27
Cleared Oct 26, 2022
TEMA Elbow system - Line extension
K222807
Lima Corporate S.P.A.
Orthopedic · 40d
Cleared Aug 05, 2020
LATITUDE EV™ Total Elbow Arthroplasty
K193247
Tornier, Inc.
Orthopedic · 254d
Cleared Dec 27, 2018
LATITUDE EV Total Elbow Arthroplasty
K182461
Tornier, Inc.
Orthopedic · 108d
Cleared Oct 15, 1997
ABC TOTAL ELBOW PROTHESIS
K972691
Biomet, Inc.
Orthopedic · 90d
Cleared Sep 20, 1996
SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
K960087
Wrightmedicaltechnologyinc
Orthopedic · 253d
Cleared Feb 05, 1996
SORBIE TOTAL ELBOW SYSTEM
K955099
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Mar 01, 1988
SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM
K880188
Howmedica Corp.
Orthopedic · 46d
Cleared Jan 20, 1983
POROCOAT MARK IV ELBOW
K823473
Depuy, Inc.
Orthopedic · 59d
Cleared Jul 02, 1982
SUFACE REPLACEMENT ELBOW
K820957
Howmedica Corp.
Orthopedic · 87d
Cleared Jan 04, 1982
ARIZONA RADIO CAPITELLAR TOTAL ELBOW
K812322
Zimmer, Inc.
Orthopedic · 140d
Cleared May 01, 1981
PRITCHARD SURFACE REPLACEMENT ELBOW
K810847
Depuy, Inc.
Orthopedic · 35d
Cleared Nov 19, 1980
HELFET ELBOW PROSTHESIS
K802460
Depuy, Inc.
Orthopedic · 42d
Cleared Oct 31, 1980
DEPALMA ELBOW
K801574
Zimmer, Inc.
Orthopedic · 114d

About Product Code JDB - Regulatory Context

510(k) Submission Activity

27 total 510(k) submissions under product code JDB since 1980, with 27 receiving FDA clearance (average review time: 96 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.