Atlas FDA

MEH

159 FDA 510(k) clearances · Product code

109 daysmedian time to decision
359 days90th percentile
159clearances measured

FDA profile

Official device name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3353
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 372 · 2022: 316 · 2023: 334 · 2024: 353 · 2025: 474 · 2026: 207
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
Allure Hip Stem and Intramedullary Plugs (K250375)Waldemar Link GmbH & Co. KG2025-11-05
Mfinity Femoral System (K251166)Medacta International S.A.2025-06-13
Trivicta® Hip Stem (K251052)Ortho Development Corp.2025-05-22
Resolve Modular Revision Hip Stem (K242315)United Orthopedic Corporation2025-05-01
Alteon® HA Femoral Stems (K243839)Exactech, Inc.2025-03-10
World Liner (K243162)Signature Orthopaedics Pty, Ltd.2024-11-25
Icona Hip Stem (K241472)Corin U.S.A. Limited2024-10-03
TheRay Collared and Collarless Femoral Stem (K241875)Nextstep Arthropedix2024-09-13
Logical Liner; World Liner; World Knee Patella (K241690)Signature Orthopaedics Pty, Ltd.2024-08-01
Trivicta™ Hip Stem (K233758)Ortho Development Corp.2024-03-08
DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (K231873)Depuy Ireland UC2024-01-19
ACTERA™ hip system (K231178)Conformis, Inc.2023-05-23
SignaSure Dual Mobility System (K220495)Signature Orthopaedics Pty, Ltd.2023-01-13
Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (K220731)Stryker2022-08-11
Actera™ hip system (K221104)Conformis, Inc.2022-08-04
SignaSure Dual Mobility System (K211742)Signature Orthopaedics Pty, Ltd.2022-01-07
Encore Hip Stem (K211505)Signature Orthopaedics Pty, Ltd.2021-09-24
Insignia Hip Stem (K211703)Stryker Orthopaedics2021-08-16
Actis DuoFix Hip Prosthesis- Collarless (K210581)Depuy Ireland UC2021-05-20
MUTARS Cemented Femoral Stems (K200045)Implantcast GmbH2020-10-16
World Hip Stem, World Cup, World Liner (K201278)Signature Orthopaedics Pty, Ltd.2020-09-21
Summit DuoFix HA Coating (K193398)DePuy Orthopaedics, Inc.2020-02-04
MUTARS Proximal Femur Replacement System (K181778)Implantcast GmbH2019-03-25
Corin TriFit CF Hip Stem (K173880)Corin U.S.A. Limited2018-04-11
LINK® BiMobile(TM) Dual Mobility System (K171273)Waldemar Link GmbH & Co. KG2018-01-19
Entrada™ hip stem (K171249)Ortho Development Corporation2017-08-24
REDAPT Sleeved Monolithic Revision Stems (K162303)Smith & Nephew, Inc.2017-05-01
Exactech® Alteon® HA Femoral Stem (K162732)Exactech, Inc.2017-04-26
Exactech® Novation® Element Press-fit Femoral Stem (K153649)Exactech, Inc.2016-08-31
H-Max S stem (K160011)Lima Corporate S.P.A.2016-08-22
Origin Coxa Vara Hip Stem (K161155)Signature Orthopaedics Pty, Ltd.2016-07-19
DePuy Actis DuoFix Hip Prosthesis (K160907)Depuy(Ireland)2016-07-19
Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner (K153131)Signature Orthopaedics Pty, Ltd.2016-06-03
Corin TriFit TS Hip (K153772)Corin U.S.A. Limited2016-03-31
H-MAX S Femoral Hip System (K150855)Lima Corporate S.P.A.2015-10-21
DePuy Actis Duofox Hip Prosthesis (K150862)DePuy Orthopaedics, Inc.2015-09-25
NOVEL FIT AND FILL STEM (K122853)Howmedica Osteonics Corp.2013-02-01
H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS (K112091)Lima Corporate S.P.A.2012-11-09
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM (K121627)Smith & Nephew, Inc.2012-10-15
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS (K113039)Smith & Nephew, Inc.2012-10-05
CORIN TRIFIT TS HIP (K121563)Corin USA2012-10-05
MODULAR PROXIMALLY FLUTED HIP STEM (K113789)Smith & Nephew, Inc.2012-04-19
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 (K113320)Exactech, Inc.2012-03-16
MSA HIP SYSTEM (K113107)Global Manufacturing Technology2011-12-15
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS (K112556)Howmedica Osteonics Corp.2011-09-28
NOVEL TAPERED HIP STEM (K103479)Stryker Corp.2011-03-10
CERAMIC FEMORAL HEAD (K103497)United Orthopedic Corp.2011-03-04
MSA HIP SYSTEM (K102172)Global Manufacturing Technology2011-03-01
PREVISION HIP SYSTEM WITH RECON RING (K102424)Aesculap Implant Systems, LLC2010-12-09
TRINITY ACETABULAR SYSTEM (K093472)Corin USA2010-11-23
SMITH & NEPHEW MDF MODULAR SLEEVE (K100481)Smith & Nephew, Inc.2010-07-15
SMITH & NEPHEW HIP SYSTEMS WITH HA (K090982)Smith & Nephew, Inc.2010-04-21
VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS (K092265)Medacta International S.A.2010-03-12
RESTORATION ADM SYSTEM X3 ACETABULAR (K093644)Howmedica Osteonics Corp.2009-12-18
ABG II MODULAR HIP STEM (K092406)Howmedica Osteonics Corp.2009-11-04
REJUVENATE MODULAR STEM (K092561)Howmedica Osteonics Corp.2009-10-20
EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM (K092143)Aesculap Implant Systems, Inc.2009-09-22
REJUVENATE MONOLITHIC SIZE 4 HIP STEM (K091161)Howmedica Osteonics Corp.2009-06-16
VERSAFIT CUP DOUBLE MOBILITY SYSTEM (K083116)Medacta International S.A.2009-04-07
REJUVENATE MONOLITHIC HIP SYSTEM (K082892)Howmedica Osteonics Corp.2008-12-29
MDF REVISION HIP SYSTEM (K081124)Smith & Nephew, Inc.2008-07-31
REJUVENATE MODULAR HIP SYSTEM (K081044)Howmedica Osteonics Corp.2008-06-03
METHA HIP SYSTEM (K071916)Aesculap Implant Systems, Inc.2008-06-02
METHA SHORT STEM HIP SYSTEM (K080584)Aesculap Implant System, Inc.2008-05-09
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS (K080980)Exactech, Inc.2008-05-06
RESTORATION ADM SYSTEM (K072020)Howmedica Osteonics Corp.2007-10-18
CERMET III ACETABULAR CUP SYSTEM (K071583)Implants International, Ltd.2007-07-25
EXCIA TOTAL HIP SYSTEM WITH U-CAP (K060437)Aesculap, Inc.2006-03-22
SHORT CITATION FEMORAL STEM (K053528)Stryker Orthopaedics2006-01-13
SMITH & NEPHEW MODULAR HIP (K052426)Smith & Nephew, Inc.2005-12-07
BICONTACT HIP SYSTEM WITH U-CAP (K043079)Aesculap2004-12-08
SMITH & NEPHEW MODULAR HIP (K042127)Smith & Nephew, Inc.2004-11-19
FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM (K041353)Jri Manufacturing, Ltd.2004-10-08
CONTOUR HA COATED RECONSTRUCTION RING (K040680)Smith & Nephew, Inc.2004-06-14
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS (K040613)Exactech, Inc.2004-06-04
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM (K032641)Portland Orthopaedics Pty. , Ltd.2004-01-20
ACCOLADE-J HIP STEM SERIES (K032300)Howmedica Osteonics Corp.2003-10-09
ECHELON POROUS PLUS HA HIP STEMS (K023302)Smith & Nephew, Inc.2002-10-25
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM (K023102)Howmedica Osteonics Corp.2002-10-09
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM (K021403)Biomet Orthopedics, Inc.2002-05-31
SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS (K020615)Howmedica Osteonics Corp.2002-05-13
ESOP HA FEMORAL STEM (K021108)Fournitures Hospitalieres2002-05-03
TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM (K020963)Biomet Orthopedics, Inc.2002-04-16
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM (K020572)Howmedica Osteonics Corp.2002-03-04
TRIDENT HEMISPHERICAL ACETABULAR SHELLS (K013676)Howmedica Osteonics Corp.2001-12-05
SYNERGY HA COATED POROUS FEMORAL STEMS (K002996)Smith & Nephew, Inc.2000-12-11
GROSS FEMORAL COMPONENT (K001580)Biomet, Inc.2000-08-17
TRIDENT ACETABULAR SHELLS: PS-HA (K001448)Howmedica Osteonics Corp.2000-08-04
BOHN FEMORAL COMPONENT (K000262)Biomet Manufacturing, Inc.2000-04-03
TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM (K994366)Howmedica Osteonics Corp.2000-03-16
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE (K000242)Exactech, Inc.2000-02-16
THE MARGRON HIP REPLACEMENT SYSTEM (K992815)Portland Orthopaedics Pty. , Ltd.2000-02-07
ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA (K993943)Encore Orthopedics, Inc.2000-02-04
CITATION TMZF HA STEM (K993768)Howmedica Osteonics Corp.2000-01-21
HOWMEDICA OSTEONICS RESTORATION HA HIP STEM (K993077)Howmedica Osteonics Corp.1999-10-08
PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING (K992025)Howmedica Osteonics Corp.1999-08-13
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL (K990666)Smith & Nephew, Inc.1999-08-06
OSTEONICS HA-COATED DEVICES (K980070)Osteonics Corp.1999-07-23
OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS (K990203)Osteonics Corp.1999-02-18
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM (K990197)Exactech, Inc.1999-02-04
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