Atlas FDA

KWL

108 FDA 510(k) clearances · Product code

78 daysmedian time to decision
229 days90th percentile
108clearances measured

FDA profile

Official device name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3360
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 107 · 2022: 99 · 2023: 48 · 2024: 143 · 2025: 29 · 2026: 32
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
REMEDY POLY+PLUS SNAP FIT Acetabular Cup (K262290)Osteoremedies, LLC2026-07-24
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement (K260536)Depuy Ireland UC2026-05-15
OsteoRemedies Hip Spacer System (K253675)Osteoremedies, LLC2025-12-23
InterSpace GV Hip Spacer (K252326)Tecres S.P.A.2025-08-06
Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (K242865)Biocomposites, Ltd.2025-06-12
COPAL® exchange G hip spacer; COPAL® G+V (K234028)Heraeus Medical GmbH2024-02-15
UHR Bipolar Implants, Restoration GAP II Implants (K222632)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022-10-21
OsteoRemedies Hip Spacer System (K192995)Osteoremedies, LLC2020-01-10
REMEDY Acetabular Cup (K191981)Osteoremedies, LLC2019-08-23
REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (K172906)Osteoremedies, LLC2018-08-29
Remedy Acetabular Cup (K173967)Osteoremedies, LLC2018-02-22
Evolve UniPolar Head (K143184)Signature Orthopaedics Pty, Ltd.2015-03-17
2GC HIP/KNEE MODULAR SPACER (K112470)Mandell Horwitz Consultants, LLC2012-04-05
Spacer-G and Spacer-K (K101356)Tecres S.P.A.2011-09-20
CORIN OPTIMOM MODULAR HEAD (K111911)Corin USA2011-08-04
SPACER-G TEMPORARY HIP PROSTHESIS (K062273)Tecres S.P.A.2008-05-22
CORIN ADAPTOR SLEEVE (K071471)Howmedica Osteonics Corp.2007-09-10
CORIN UNIPOLAR MODULAR HEAD (K063791)Corin USA2007-04-03
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD (K062408)Smith & Nephew, Inc.2006-09-12
SMITH & NEPHEW MODULAR FEMORAL HEAD (K061243)Smith & Nephew, Inc.2006-07-17
SOLITUDE UNIPOLAR HEAD (K042973)Ortho Development Corp.2005-01-27
SPACER G TEMPORARY HIP PROSTHESIS (K031841)Exactech, Inc.2004-01-22
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) (K030972)Disc-O-Tech Medical Technologies, Ltd.2003-05-30
CONSENSUS UNIPOLAR HEAD, COCR (K030205)Hayes Medical, Inc.2003-04-01
UNITRAX MODULAR UNIPOLAR SYSTEM (K014226)Howmedica Osteonics Corp.2002-01-25
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE (K992570)Howmedica Osteonics Corp.1999-09-01
PLUS FRACTURE HEAD PROSTHESIS (K990309)Plus Orthopedics1999-03-15
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE (K984585)Osteonics Corp.1999-02-24
THE NEW BIO-MOORE ENDO HEADS (K984028)Biomet, Inc.1999-01-19
ARGOMEDICAL BIPOLAR SYSTEM (K981451)Stelkast Company1998-08-21
OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM (K974807)Osteonics Corp.1998-03-16
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES (K973614)Encore Orthopedics, Inc.1997-12-18
ULTIMA TPS CEMENTED STEM (K965198)Johnson & Johnson International1997-07-23
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES (K965156)Johnson & Johnson Professionals, Inc.1997-01-24
PRIME MODULAR ENDO HEAD (K962646)Orthopaedic Innovations, Inc.1996-09-23
OPTEON UNIPOLAR (K960538)Exactech, Inc.1996-03-27
JOHNSON & JOHNSON AUSTIN MOORE STEM (K955385)Johnson & Johnson Professionals, Inc.1996-01-30
OSTEONICS UNIPOLAR ENDO HEAD (K954534)Osteonics Corp.1995-11-30
UNITRAX V40 MODULAR ADAPTOR (K954077)Howmedica Corp.1995-11-15
OSTEONICS RESTORATION CEMENTED HIP STEM SERIES (K943778)Osteonics Corp.1995-08-14
ULTIMA AUGMENTED UHMWPE CUP (K950563)Johnson & Johnson Professionals, Inc.1995-06-07
LINK SADDLE PROTHESIS (K951355)Turnkey Intergration USA, Inc.1995-05-25
CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION (K931752)Corin Orthopedic Products1994-10-07
CORIN THOMPSON PROSTHESIS, MODIFICATION (K931753)Corin Orthopedic Products1994-10-07
ULTIMA UNIPOLAR MODULAR HEAD (K940190)Johnson & Johnson Orthopaedics, Inc.1994-09-29
ZIRCONIUM ALLOY UNI-POLAR HEAD (K934353)Smith & Nephew Richards, Inc.1994-04-25
TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT (K924050)Orthomet, Inc.1993-08-25
CONTOUR FEMORAL HIP STEM WITH POROCOAT (K926120)Depuy, Inc.1993-03-31
ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM (K924379)Johnson & Johnson Orthopaedics, Inc.1993-02-12
OSTRONCS HEMI-HIP STEM SERIES (K922146)Osteonics Corp.1992-08-11
OMNIFLEX M-HA HIP STEM SERIES (K920193)Stryker Corp.1992-06-08
OMNIFIT M-HA HIP STEM SERIES (K920231)Stryker Corp.1992-06-08
PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT (K915868)Orthomet, Inc.1992-03-23
MTS FEMORAL HIP SYSTEM (K903877)3M Company1991-01-18
MODULAR UNIPOLAR SYSTEM (K902365)Howmedica Corp.1991-01-11
AUSTIN MOORE TYPE HIP PROTHESIS (K905349)O'Tec Corp.1990-12-11
THOMPSON TYPE HIP PROSTHESIS (K905334)O'Tec Corp.1990-12-11
PROFILE COLLARED HIP PROSTHESIS (K904119)Depuy, Inc.1990-10-11
KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD (K903884)Kinamed, Inc.1990-09-13
KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD (K903885)Kinamed, Inc.1990-09-13
AUSTIN MOORE TYPE HIP PROSTHESIS (K903241)Onyx Medical Corp.1990-07-30
THOMPSON TYPE HIS PROSTHESIS (K903240)Onyx Medical Corp.1990-07-30
PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA (K896853)Howmedica Corp.1990-05-02
P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT (K900638)Johnson & Johnson International1990-04-30
EVOLUTION HIP SYSTEM (K896105)Dow Corning Wright1989-12-29
BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM (K895886)Biopro, Inc.1989-12-01
AML(R) COLLARLESS LATERALIZED FEMORAL HIP (K891482)Depuy, Inc.1989-05-16
MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. (K884889)Protek, Inc.1989-02-27
NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI (K884789)Protek, Inc.1989-02-08
HIP FRACTURE STEM SYSTEM (K883179)Howmedica Corp.1988-09-22
ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS (K874915)Orthomet, Inc.1988-02-03
BIOPRO FEMORAL HIP COMPONENT (K872535)Biopro, Inc.1987-08-26
PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT (K872776)Depuy, Inc.1987-08-24
POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS (K872025)Depuy, Inc.1987-08-18
TRI-LOCK MODIFIED FEMORAL PROSTHESIS (K872878)Depuy, Inc.1987-08-07
ORTHOMET AUSTIN-MOORE SYSTEM (K871656)Orthomet, Inc.1987-06-09
BROOKER BIO-GROOVE FEMORAL COMPONENT (K864085)Biomet, Inc.1987-01-28
BIO-FIT HIP SYSTEM (K854791)Richards Medical Co., Inc.1986-02-27
FEMORAL HEMI-HIP PROSTHESES (K855228)Orthopaedic Device Corp.1986-02-11
MUELLER CURVED STEM HEMI-PROSTHESIS (K853662)Protek, Inc.1985-09-24
POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT (K852584)Biomet, Inc.1985-08-15
NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS (K844818)Osteonics Corp.1985-07-30
BTM TOTAL HIP SYSTEM (K852420)Kirschner Medical Corp.1985-06-28
V.E.P. HIP -VARIABLE ENDO-PROSTHESIS (K850928)Unitas Ent.1985-05-28
TF-II HIP PROSTHESIS (K843995)Dow Corning Corp. Healthcare Industries Materials1985-04-23
AUSTIN-MOORE MODULAR HIP PROSTHESIS (K845025)Biomet, Inc.1985-04-19
MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS (K844488)Mecron Medical Products, Inc.1985-03-12
MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR (K844487)Mecron Medical Products, Inc.1985-02-19
MECRON MRC-HEADLESS FEMORAL COMPONENT (K844486)Mecron Medical Products, Inc.1985-02-19
WHITESIDE ORTHOLOC TOTAL HIP FEMORAL (K842559)Dow Corning Corp. Healthcare Industries Materials1984-12-20
UNILOC (K842465)American Ortomed Corp.1984-11-19
NEW JERSEY FEMORAL STEM (K842234)Endomedics, Inc.1984-07-20
PENNSYLVANIA HOSPITAL HIP SYS (K841437)Biomet, Inc.1984-06-25
MODIFIED HPS HIP PROSTHESIS (K833599)Depuy, Inc.1984-03-19
BDH UNIPOLAR FEMORAL COMPONENT A2 (K833403)Carbomedics, Inc.1984-01-10
STRAIGHT STEM FEMORAL HEAD PROSTHESIS (K831851)Proteck, Inc.1983-10-06
HIP PROSTHESIS -VARIOUS (K831420)The Oec Group1983-09-20
AUFRANC-TURNER ATS TOTAL HIP SYSTEM (K830307)Howmedica Corp.1983-03-10
METAL KNEE & HIP PROSTHESIS (K823051)Zimmer, Inc.1982-12-03
IOI 32 TM FEMORAL COMPONENT (K822321)Intermedics Orthopedics1982-08-20
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Every clearance here is in the API, with alerts when new ones post.