Atlas FDA

LWJ

81 FDA 510(k) clearances · Product code

99 daysmedian time to decision
263 days90th percentile
81clearances measured

FDA profile

Official device name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3360
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 155 · 2022: 91 · 2023: 72 · 2024: 54 · 2025: 52 · 2026: 30
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
UNISYN PLUS HIP STEM (K120595)Consensus Orthopedics, Inc.2012-10-12
TRINITY ACETABULAR SYSTEM (K103518)Corin USA2011-03-09
NOVATION CFS PRESS-FIT AND CEMENTED STEMS (K090764)Exactech, Inc.2009-04-21
METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD (K082146)Aesculap Implant Systems, Inc.2008-09-09
36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT (K070061)Hayes Medical, Inc.2007-01-31
U2 HIP STEM, TI PLASMA SPRAY (K062978)United Orthopedic Corp.2007-01-16
UNISYN HA PLASMA MODULAR HIP (K062383)Hayes Medical, Inc.2006-12-21
EXCIA (K061699)Aesculap, Inc.2006-08-18
BETACONE HIP PROSTHESIS SYSTEM (K051826)Waldemar Link GmbH & Co. KG2005-11-18
U2 ACETABULAR COMPONENT (K050262)United Orthopedic Corp.2005-08-15
EXCIA TOTAL HIP SYSTEM (K042344)Aesculap, Inc.2005-03-16
Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED (K040685)Osteoimplant Technology, Inc.2005-01-25
QUATRO M FEMORAL COMPONENT (K033313)Whiteside Biomechanics, Inc.2004-07-28
MODULAR PLUS HIP STEM (K032709)Plus Orthopedics2003-09-23
PROCLASS PRESS FIT HIP STEM (K032110)Stelkast Company2003-09-22
MODIFICATION TO MODULAR PLUS REVISION STEM (K030971)Plus Orthopedics2003-04-24
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER (K023692)Howmedica Osteonics Corp.2003-03-20
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM (K030122)DePuy Orthopaedics, Inc.2003-02-05
UNI HIP STEM (K024134)Plus Orthopedics2003-01-15
PROXILOCK HIP PROSTHESIS; SIZE 12/36 (K022966)Implex Corp.2002-10-02
TRITON HIP SYSTEM (K003649)Hayes Medical, Inc.2001-02-23
TRI-FIT FEMORAL STEM (K010243)Corin USA2001-02-15
PRO-FEMUR R (K003016)Wrightmedicaltechnologyinc2000-12-13
EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP (K994146)Plus Orthopedics2000-12-11
ACETABULAR PLATES (K002941)Encore Orthopedics, Inc.2000-12-04
INTER-OP DURASUL ACETABULAR INSERTS (4MM) (K002575)Sulzer Orthopedics, Inc.2000-11-15
MODIFICATION TO PROVIDENT HIP SYSTEM (K002796)Stelkast Company2000-09-28
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT (K002141)Exactech, Inc.2000-08-16
THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ (K001471)Implex Corp.2000-08-07
MODIFICATION TO PROVIDENT HIP SYSTEM (K001745)Stelkast Company2000-07-27
SL-PLUS AND SLR-PLUS STEMS (K001942)Plus Orthopedics2000-07-25
MODULAR-PLUS REVISION STEM (K994126)Plus Orthopedics2000-05-04
HOWMEDICA OSTEONICS FEMORAL HEADS (K993601)Howmedica Osteonics Corp.1999-11-16
OSTEONICS EXTENDED FEMORAL BEARING HEAD (K982936)Osteonics Corp.1998-10-21
LATERAL FLARE INTERNAL COLLAR (LFIC) (K971900)Pro-Lfic, LLC1997-12-18
PLUS EPF ACETABULAR CUP (K972931)Hhl Consulting1997-11-13
PLUS-FIT ACETABULAR CUP (K973077)Plus Orthopedics1997-11-13
PRESS-FIT HIP STEM (K964178)Encore Orthopedics, Inc.1997-05-05
PERFECTA REVISION HIP SYSTEM (K955553)Wrightmedicaltechnologyinc1996-10-24
SC, CEMENTLESS HIP SYSTEM (K962034)Artos Medical Products GmbH1996-10-23
CHROME COBALT BALL HEAD (K962268)Artos Medical Products GmbH1996-10-23
DELTA HIP PROSTHESIS (K961378)Zimmer, Inc.1996-10-08
INTERMOORE FRACTURE HIP STEM (MODIFY) (K963155)Intermedics Orthopedics1996-10-01
PRESS-FIT FLARED SHELL (K960633)Encore Orthopedics, Inc.1996-10-01
SRRS PRESSED FIT FEMORAL REVISION COMPONENT (K960908)Stelkast Company1996-08-08
INTERMOORE FRACTURE HIP STEM (K954854)Intermedics Orthopedics1996-02-15
LFIC OR FETTO HIP (K952776)Zimmer, Inc.1996-02-14
DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT (K953268)Stelkast Company1996-01-17
FOUNDATION TEXTURED STEM (K952297)Encore Orthopedics, Inc.1995-07-17
HOWMEDICA V40 22MM FEMORAL HEAD (K950541)Howmedica Corp.1995-03-21
PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM (K931423)Orthomed1994-10-13
COBALT CHROME GEMINI (K934909)Depuy, Inc.1994-04-28
OSTEONICS 22MM, +10 NECK BEARING HEADS (K933359)Osteonics Corp.1994-03-07
FUTURA TEXTURE-TRAKKED TOTAL HIP STEM (K921382)Arthronics, Inc.1994-01-07
INTRINSIC STEM (K923911)Turnkey Intergration USA, Inc.1993-04-14
MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN. (K910664)Medimix Products, Inc.1992-04-01
VENUS HIP (K913708)Turnkey Intergration USA, Inc.1992-01-27
TI-FIT FEMORAL COMPONENT (K914343)Smith & Nephew Richards, Inc.1992-01-13
HOWMEDICA HNR SYSTEM (K903563)Howmedica Corp.1991-03-14
Q SYSTEM 28 HIP STEM (K910010)Turnkey Intergration USA, Inc.1991-03-12
THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH (K905254)Depuy, Inc.1991-02-26
GERI TOTAL HIP SYSTEM (K905186)Smith & Nephew Richards, Inc.1991-02-15
ACSYS SHEARER ACETABULAR CUP PROSTHESIS (K900435)3M Company1990-09-14
ACSYS SELFTAP ACETABULAR CUP PROSTHESIS (K900262)3M Company1990-09-14
F-24 FEMORAL HIP PROSTHESIS (K901687)Med-Tek Corp.1990-09-07
H.N. TOTAL HIP PROSTHESIS (K901594)Med-Tek Corp.1990-08-03
KDR ACETABULAR COMPONENT (K895702)Osteonics Corp.1989-11-03
FREEMAN TOTAL HIP SYSTEM RIDGED STEM (K890331)Orthopedic Systems, Inc.1989-10-13
PREMIER-TOTAL HIP (K894051)Intermedics Orthopedics1989-08-28
ARC-2F ACETABULAR CUP (K893785)Protek, Inc.1989-08-09
GRIPPER II ACETABULAR CUP (K893584)Joint Medical Products Corp.1989-07-28
CTI II STRAIGHT STEM (K891539)Orthopedic Systems, Inc.1989-06-08
KDG ACETABULAR COMPONENT (K891262)Osteonics Corp.1989-06-06
RESUBMITTED CLW ACETABULAR CUP W/SULMESH (K883794)Protek, Inc.1989-05-26
MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS) (K883661)Depuy, Inc.1989-02-08
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING (K883921)Osteonics Corp.1988-10-13
HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT (K881983)Howmedica Corp.1988-10-06
CORIN MODULAR MOORE STEM (K881288)Orthopedic Systems, Inc.1988-06-29
S-ROM SUPERCUP ACETABULAR CUP (K870088)Joint Medical Products Corp.1988-04-22
TI-FIT TOTAL HIP SYSTEM (K873797)Richards Medical Co., Inc.1987-11-02
MICRO-STRUCTURED HS2P HIP STEMS (K833970)Osteonics Corp.1984-01-27

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