Atlas FDA

JDB

27 FDA 510(k) clearances · Product code

90 daysmedian time to decision
155 days90th percentile
27clearances measured

FDA profile

Official device name
Prosthesis, Elbow, Semi-Constrained, Cemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3160
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 23 · 2022: 58 · 2023: 29 · 2024: 163 · 2025: 38 · 2026: 131
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
TEMA Elbow system - Line extension (K222807)Lima Corporate S.P.A.2022-10-26
LATITUDE EV™ Total Elbow Arthroplasty (K193247)Tornier, Inc.2020-08-05
LATITUDE EV Total Elbow Arthroplasty (K182461)Tornier, Inc.2018-12-27
Latitude EV Total Elbow Arthroplasty (K171010)Tornier, Inc.2017-08-31
RHEAD RADIAL HEAD EXTENDED STEMS (K102180)Small Bone Innovations, Inc.2010-12-20
LATITUDE ELBOW PROSTHESIS (K100562)Tornier, Inc.2010-06-29
LATITUDE ELBOW PROTHESIS (K070787)Tornier2007-08-24
SBI LATERAL RADIO CAPITELLUM (K070236)Small Bone Innovations, Inc.2007-02-21
RHS (K060438)Tornier2006-04-18
SBI RADIO-CAPITELLAR IMPLANT (K060038)Small Bone Innovations, Inc.2006-03-30
TORNIER ELBOW PROSTHESIS (K050848)Tornier2005-07-14
MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS (K031218)Tornier2003-05-16
TORNIER TOTAL ELBOW PROSTHESIS (K011567)Tornier2001-06-19
CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS (K983141)Johnson & Johnson Professionals, Inc.1998-11-06
ABC TOTAL ELBOW PROTHESIS (K972691)Biomet, Inc.1997-10-15
SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) (K960087)Wrightmedicaltechnologyinc1996-09-20
SORBIE TOTAL ELBOW SYSTEM (K955099)Wrightmedicaltechnologyinc1996-02-05
SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM (K880188)Howmedica Corp.1988-03-01
ROPER-TUKE ELBOW (K873660)Orthopedic Systems, Inc.1988-01-06
POROCOAT MARK IV ELBOW (K823473)Depuy, Inc.1983-01-20
SUFACE REPLACEMENT ELBOW (K820957)Howmedica Corp.1982-07-02
ARIZONA RADIO CAPITELLAR TOTAL ELBOW (K812322)Zimmer, Inc.1982-01-04
RADIAL HEAD PROSTHESIS (K811451)Cintor Orthopaedic Div.1981-06-09
PRITCHARD SURFACE REPLACEMENT ELBOW (K810847)Depuy, Inc.1981-05-01
TRIAXIAL (K802348)Johnson & Johnson Professionals, Inc.1981-02-23
HELFET ELBOW PROSTHESIS (K802460)Depuy, Inc.1980-11-19
DEPALMA ELBOW (K801574)Zimmer, Inc.1980-10-31

Track JDB automatically

Every clearance here is in the API, with alerts when new ones post.