Atlas FDA

KWA

114 FDA 510(k) clearances · Product code

91 daysmedian time to decision
237 days90th percentile
114clearances measured

FDA profile

Official device name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class
Class III (high risk)
Regulation
21 CFR 888.3330
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 2,064 · 2022: 1,617 · 2023: 1,475 · 2024: 1,168 · 2025: 1,228 · 2026: 650
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PROFEMUR Z REVISION HIP STEM (K122778)Wrightmedicaltechnologyinc2012-10-11
DYNASTY BIOFOAM SHELL (K121544)Wrightmedicaltechnologyinc2012-07-30
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS (K113271)Biomet Manufacturing, Inc.2012-05-18
CONSERVE THIN SHELL (K113322)Wrightmedicaltechnologyinc2012-02-03
PRESERVE HIP STEM (K112080)Wrightmedicaltechnologyinc2011-12-28
PROFEMUR GLADIATOR HA HIP STEM (K112150)Wrightmedicaltechnologyinc2011-11-23
PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER (K113019)Wrightmedicaltechnologyinc2011-11-10
GLADIATOR HIP STEM (K111910)Wrightmedicaltechnologyinc2011-10-14
CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY (K110836)Zimmer GmbH2011-10-07
TAPERLOC COMPLETE MICROPLASTY STEM (K110400)Biomet Manufacturing Corp2011-09-30
PROFEMUR(R) E CEMENTLESS HIP STEM (K111698)Wrightmedicaltechnologyinc2011-08-19
PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM (K111699)Wrightmedicaltechnologyinc2011-08-19
GLADIATOR PLASMA CLASSIC HIP STEM (K110399)Wrightmedicaltechnologyinc2011-05-10
CONSERVE BIO FOAM SHELL (K110029)Wrightmedicaltechnologyinc2011-04-19
TAPERLOC COMPLETE, SIZE 5 AND 6 (K103755)Biomet Manufacturing Corp2011-01-21
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS (K102565)Wrightmedicaltechnologyinc2010-12-22
ARCOS INTERLOCKING DISTAL STEMS (K100469)Biomet Manufacturing Corp2010-12-07
TAPERLOC COMPLETE (K101086)Biomet, Inc.2010-09-03
COMPRESS ANTI-ROTATION SPINDLES (K101475)Biomet Manufacturing Corp2010-06-18
RINGLOC + HYBRID ACETABULAR SYSTEM (K093235)Biomet, Inc.2010-04-30
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; (K092331)Encore Medical L.P.2010-03-03
ZIMMER MMC CUP (K091003)Zimmer GmbH2009-11-24
METASUL TAPER LINERS, METASUL FEMORAL HEADS (K091973)Zimmer GmbH2009-11-17
BIOMET MODULAR FEMORAL REVISION SYSTEM (K090757)Biomet, Inc.2009-09-25
PROFEMUR HIP SYSTEM MODULAR NECKS (K091423)Wrightmedicaltechnologyinc2009-08-25
REVELATION STEM, MODEL 427-21/42-080/180 (K083651)Encore Medical L.P.2009-03-13
DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER (K082924)Wrightmedicaltechnologyinc2009-03-06
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K083642)DePuy Orthopaedics, Inc.2009-03-06
DEPUY ASPHERE M-SPEC HEAD (K082585)DePuy Orthopaedics, Inc.2008-12-04
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS (K082446)Biomet, Inc.2008-10-15
DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM (K080991)DePuy Orthopaedics, Inc.2008-07-02
PROFEMUR LX 5/8 COATED HIP STEM (K081090)Wrightmedicaltechnologyinc2008-05-15
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM (K081007)Zimmer, Inc.2008-05-06
PROFEMUR LX REVISION 5/8 COATED HIP STEM (K080663)Wrightmedicaltechnologyinc2008-04-08
PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS (K073637)Biomet Manufacturing Corp2008-03-20
ZIMMER POROLOCK MIS STEM (K071723)Zimmer GmbH2008-03-07
DEPUY ASR 300 ACETABULAR CUP SYSTEM (K073413)DePuy Orthopaedics, Inc.2008-01-30
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES (K071856)Zimmer, Inc.2007-07-30
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 (K070221)Encore Medical L.P.2007-04-04
ECHO BI-METRIC PRESS-FIT STEMS (K070274)Biomet Manufacturing Corp2007-04-03
LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS (K062994)Biomet Manufacturing Corp2007-03-09
DEPUY ASR TAPER SLEEVE ADAPTER (K070359)DePuy Orthopaedics, Inc.2007-03-06
ALTRA FX HIP SYSTEM (K063614)Biomet Manufacturing Corp2007-02-20
ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY (K063251)Zimmer, Inc.2007-01-24
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) (K062998)Biomet Manufacturing Corp2007-01-19
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K062426)DePuy Orthopaedics, Inc.2006-12-15
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 (K063414)Encore Medical L.P.2006-12-12
ALTRA PRESS-FIT HIP SYSTEM (K063002)Biomet Manufacturing Corp2006-10-31
M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT (K062995)Biomet Manufacturing Corp2006-10-31
DUPUY S-ROM STD HIP STEM PROSTHESIS (K061221)DePuy Orthopaedics, Inc.2006-08-28
M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS (K061423)Biomet Manufacturing Corp2006-07-27
PROFEMUR TL HIP STEM (K060358)Wrightmedicaltechnologyinc2006-05-10
CONSERVE PLUS QUADRAFIX ACETABULAR SHELL (K060356)Wrightmedicaltechnologyinc2006-04-18
DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS (K053536)Zimmer GmbH2006-03-16
PROFEMUR XTR HIP STEM (K052915)Wrightmedicaltechnologyinc2006-01-27
PROFEMUR LX HIP STEM (K053588)Wrightmedicaltechnologyinc2006-01-13
ENCORE CLP OFFSET TOTAL HIP SYSTEM (K052320)Encore Medical Corporation2005-12-30
POROUS TITANIUM ACETABULAR AUGMENTS (K052888)Biomet Manufacturing Corp2005-12-06
POROUS COATED ACETABULAR COMPONENTS (K050124)Biomet, Inc.2005-10-04
LINEAGE HA ACETABULAR SHELLS (K043099)Wrightmedicaltechnologyinc2005-09-29
DEPUY ASR MODULAR ACETABULAR CUP SYSTEM (K040627)DePuy Orthopaedics, Inc.2005-08-05
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (K043547)Biomet, Inc.2005-08-05
BALANCE HIP SYSTEM (K050251)Biomet, Inc.2005-05-27
PROCOTYL-E ACETABULAR SYSTEM (K043073)Wrightmedicaltechnologyinc2005-05-04
CONSERVE PLUS HA ACETABULAR SHELLS (K042530)Wrightmedicaltechnologyinc2004-12-17
METAL/METAL HIP SYSTEM (K040354)Encore Medical L.P.2004-11-04
ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED (K033943)Centerpulse Orthopedics, Inc.2004-10-18
M2A MAGNUM SYSTEM (K042037)Biomet, Inc.2004-10-01
EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED (K033634)Centerpulse Orthopedics, Inc.2004-09-15
CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL (K041425)Wrightmedicaltechnologyinc2004-06-25
CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD (K031963)Wrightmedicaltechnologyinc2003-10-31
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER (K023786)DePuy Orthopaedics, Inc.2002-12-10
METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) (K021349)Wrightmedicaltechnologyinc2002-07-01
M2A ACETABULAR SYSTEM (K011110)Biomet, Inc.2001-07-02
ALLOFIT ACETABULAR SYSTEM (K003758)Sulzer Orthopedics, Inc.2001-03-07
FMP METAL/METAL ACETABULAR INSERT (K003250)Encore Orthopedics, Inc.2001-01-25
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K003523)DePuy Orthopaedics, Inc.2000-12-13
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS (K002883)DePuy Orthopaedics, Inc.2000-10-13
M2A 28MM RINGLOC LINER (K002379)Biomet, Inc.2000-08-31
ULTIMA METAL-ON-METAL ACETABULAR CUP (K001523)DePuy Orthopaedics, Inc.2000-08-10
INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS (K001536)Sulzer Orthopedics, Inc.2000-07-27
METAL ON METAL ACETABULAR SYSTEM (K993438)Biomet, Inc.2000-05-18
APR METASUL ACETABULAR INSERT (K993569)Sulzermedica1999-12-01
INTER-OP METASUL ACETABULAR SYSTEM (K974728)Sulzer Orthopedics, Inc.1999-08-03
THOMPSON TYPE HIP PROTHESIS (K922868)Osteo Technology, Inc.1993-02-12
MODIFIED FREEMAN ACETABULAR CUP (K902110)Turnkey Intergration USA, Inc.1990-08-22
MODIFIED FREEMAN REVISION ACETABULAR CUP (K902111)Turnkey Intergration USA, Inc.1990-08-22
H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED (K901626)Med-Tek Corp.1990-08-14
S.A.F. ACETABULAR CUP (K895157)Synergy Orthopaedics Intl., Inc.1989-12-01
RS-CUP ACETABULAR PROSTHESIS (K885049)Allo Pro Corp.1989-01-13
SAMUELSON SCREWLOC CUP (K882671)Protek, Inc.1988-10-20
ATH METAL:UHMWPE TOTAL HIP SYSTEM (K882675)Kinamed, Inc.1988-08-19
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT. (K872768)Osteonics Corp.1988-01-14
SAMUELSON ACETABULAR CUP (K872985)Protek, Inc.1987-10-01
CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT. (K870924)Protek, Inc.1987-09-14
SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX. (K870923)Protek, Inc.1987-09-14
ZWEYMUELLER-SL HIP PROSTHESIS STEM (K871453)Allo Pro Corp.1987-07-13
MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT (K871956)Downs Surgical , Ltd.1987-06-23
RING UPM TOTAL HIP REPLACEMENT (K864515)Downs Surgical , Ltd.1987-03-13
(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT (K861723)Osteonics Corp.1986-06-09
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