Atlas FDA

JDL

45 FDA 510(k) clearances · Product code

92 daysmedian time to decision
413 days90th percentile
45clearances measured

FDA profile

Official device name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device class
Class III (high risk)
Regulation
21 CFR 888.3320
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2020: 94 · 2021: 68 · 2022: 49 · 2023: 32 · 2024: 27 · 2026: 16
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
VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES (K073499)Zimmer, Inc.2008-08-07
DYNASTY ACETABULAR SYSTEM (K070785)Wrightmedicaltechnologyinc2007-07-11
DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER (K061844)Wrightmedicaltechnologyinc2006-12-06
PROFEMUR RENAISSANCE HIP STEM (K051995)Wrightmedicaltechnologyinc2005-08-22
CONSERVE TOTAL FEMORAL HEAD (K051348)Wrightmedicaltechnologyinc2005-08-19
M2A/C2A ACETABULAR SYSTEM (K042841)Biomet, Inc.2004-12-21
PROFEMUR S HIP STEM (K041586)Wrightmedicaltechnologyinc2004-07-09
PROFEMUR TAPERED HIP STEM (K041114)Wrightmedicaltechnologyinc2004-05-28
METAL TRANSCEND ARTICULATION SYSTEM (K004043)Wrightmedicaltechnologyinc2001-07-13
METAL BACKED ACETABULAR COMPONENT (K950542)Encore Orthopedics, Inc.1995-05-25
P.F.C. APICAL PLUG (K944769)Johnson & Johnson Professionals, Inc.1994-12-08
ACETABULAR DOME HOLE PLUGS (K942809)Osteonics Corp.1994-09-20
S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG (K931676)Joint Medical Products Corp.1994-05-18
PCA(R) SOLID BACK ACETABULA SHELL (K930833)Howmedica Corp.1994-02-22
PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES (K934440)Howmedica Corp.1994-02-22
SYRIGENE PRE-FILLED SYRINGE (K935669)Regulatory & Marketing Services, Inc.1994-02-18
CONSENSUS(TM) TOTAL HIP SYSTEM (K922561)U.S. Medical Products, Inc.1993-07-21
FPC/SFPC/RFPC ACETABULAR COMPONENT (K915529)Implantology Corp.1993-07-13
CPS ACETABULAR COMPONENT (K915527)Implantology Corp.1993-06-24
BIOMETRIC SCREW FIXATION CUP (K922861)Osteo Technology, Inc.1993-05-12
POLY INSERT 20 DEGREE (K920929)Dow Corning Wright1993-05-05
TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP (K925181)Techmedica, Inc.1993-02-05
HEALEY REVISION COMPONENT SYSTEM (K921139)Biomet, Inc.1992-07-01
PCA ACETABULAR INSERT II (K921384)Howmedica Corp.1992-06-25
ACETABULAR DOME AND SCREW HOLE PLUGS (K920868)Osteonics Corp.1992-05-26
S.A.F. ACETABULAR CUP WITH POROUS COATING (K896614)Synergy Orthopaedics Intl., Inc.1990-01-09
POROUS-COATED TITANIUM ACETABULAR CUP (K894965)Dow Corning Wright1989-11-17
POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT (K895607)Exactech, Inc.1989-11-17
PNEUMOTHORAX KIT, MOTIFICATION (K892640)Arrow Intl., Inc.1989-10-11
KM-4(TM) METAL-BACKED ACETABULAR CUP (K870867)Kirschner Medical Corp.1987-05-08
P.T.H. METAL-BACKED ACETABULAR CUP (K870234)Orthopaedic Device Corp.1987-03-20
JOINT MEASUREMENT INDICATOR (K861264)Devcom, Inc.1986-04-15
KM-3 ACETABULAR COMPONENT (K855042)Kirschner Medical Corp.1986-03-14
DIMENSION TOTAL HIP PROSTHESIS POROUS COATED (K854107)Kirschner Medical Corp.1986-03-10
LINK METAL-BACKED ACETABULAR CUPS (K854935)Link America, Inc.1986-03-05
LIDGRER-LUND ACETABULAR SOCKETS (K852369)Link America, Inc.1985-06-18
MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA (K850793)Intermedics Orthopedics1985-05-09
MICRO-STRUC. ACETABULAR COMPON- MC2P (K850352)Osteonics Corp.1985-04-25
MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT (K844482)Advanced Biosearch Assn.1985-02-19
DORR HIP PROSTHESIS, ACETABULAR COMPON (K842893)Carbomedics, Inc.1984-11-08
SELF-ALIGNING ACETABULAR COMPONENT (K831792)Endomedics, Inc.1984-09-20
NATURAL LOCK ACETABULAR COMPONENT (K830662)Advanced Biosearch Assn.1983-04-11
101-32 FEMORAL COMPONENT (K813599)Intermedics Orthopedics1982-01-22
BG PROXIMAL FEMUR (K790274)Howmedica Corp.1979-03-26
PROSTHESIS, VIDAL TOTAL HIP (K770472)Howmedica Corp.1977-03-17

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