Atlas FDA

JDI

564 FDA 510(k) clearances · Product code

87 daysmedian time to decision
261 days90th percentile
564clearances measured

FDA profile

Official device name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3350
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 3,170 · 2022: 1,978 · 2023: 1,635 · 2024: 1,821 · 2025: 1,670 · 2026: 992
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
OSSTM Orthopedic Salvage System (K253434)Biomet, Inc.2026-07-01
Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (K252824)Signature Orthopaedics Pty, Ltd.2026-03-12
Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (K243571)Zimmer Biomet2025-07-31
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems (K240783)Smith & Nephew, Inc.2024-10-21
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component (K241716)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2024-08-02
Stryker Orthopaedics Hip Systems Labeling Update (K240418)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2024-04-12
Global Modular Replacement System (K233261)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2023-12-08
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee (K222056)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-01-26
C-Stem AMT LE Prosthesis (K220216)Depuy Ireland UC2022-07-22
Exeter® X3® RimFit® Cup (K213701)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022-02-01
MPO Hip Instruments (K213816)Microport Orthopedics, Inc.2022-01-05
VerSys Cemented Revision/Calcar (K210842)Zimmer, Inc.2021-12-10
ELEOS Limb Salvage System with BioGrip (K203815)Onkos Surgical2021-06-09
ELEOS™ Limb Salvage System (K203588)Onkos Surgical2021-02-05
ELEOS Limb Salvage System featuring BIOGRIP (K203090)Onkos Surgical2020-12-11
PROFEMUR® GLADIATOR® Cemented Classic Stem (K201519)Microport Orthopedics, Inc.2020-12-10
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup (K193429)Howmedica Osteonics Corp.2020-08-13
ZCA All-Poly Acetabular Cups (K191449)Zimmer, Inc.2020-07-16
Zimmer, Inc. Hip Joint Prostheses MR Labeling I (K200823)Zimmer, Inc.2020-07-09
CPT Hip System (K191735)Zimmer, Inc.2020-03-20
Conformity stem, cemented (K191056)United Orthopedic Corporation2020-01-03
EXETER Centralizer, EXETER 2.5mm Plug (K191414)Stryker Orthopaedics2019-08-28
Cemented TSI Hip Stem (K181340)Signature Orthopaedics Pty, Ltd.2019-02-11
Libertas Hip Replacement System (K180973)Maxx Orthopedics, Inc.2018-09-28
MALUC™ Total Hip Arthroplasty System (K162125)Surgtech, Inc.2017-05-10
REDAPT Anteverted Cemented Liner (K160923)Smith & Nephew, Inc.2016-11-17
FitRite™ Total Hip Arthroplasty System (K153057)Excera Orthopedics, Inc.2016-06-23
Corin TaperFit Hip Stem (K153725)Corin U.S.A. Limited2016-03-25
Alpine Cemented Hip System (K153216)Ortho Development Corporation2016-02-18
OSS/Arcos IM Total Femur Rod (K152621)Biomet, Inc.2015-10-14
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial (K142814)Biomet Manufacturing, LLC2015-06-25
Corin TaperFit Hip Stem (K142761)Corin USA2015-04-03
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) (K141331)Biomet, Inc.2014-10-27
Sirius Femoral Stem, Size 30A (K142295)Biomet, Inc.2014-09-15
RENOVIS CEMENTED HIP SYSTEM (K141370)Renovis Surgical Technologies, Inc.2014-09-02
SIRIUS FEMORAL STEM (K130610)Biomet, Inc.2013-08-30
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION (K123598)Smith & Nephew, Inc.2013-06-28
OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS (K123501)Biomet, Inc.2013-02-27
METS MODULAR PROXIMAL FEMUR (K121056)Stanmore Implants Worldwide , Ltd.2012-09-20
METS MODULAR TOTAL FEMUR (K121055)Stanmore Implants Worldwide , Ltd.2012-09-19
SIGNATURE PLANNER,SIGNATURE GUIDES (K111863)Materialise NV2012-06-15
ACCOLADE II HIP STEM (K120578)Howmedica Osteonics2012-03-29
EXETER X3 RIMFIT ACETABULAR CUP (K111848)Stryker Corp.2011-10-05
EXETER HIP STEM (K110290)Howmedica Osteonics Corp.2011-09-27
DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS (K093646)DePuy Orthopaedics, Inc.2009-12-17
DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS (K090998)DePuy Orthopaedics, Inc.2009-06-12
BIOPRO FEMORAL HEADS (K090208)Biopro, Inc.2009-05-22
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS (K082792)Medacta International S.A.2008-12-29
DEPUY C-STEM AMT (K082239)DePuy Orthopaedics, Inc.2008-08-29
ACCIN UNIPOLAR HEAD SYSTEM (K080539)Accelerated Innovation, LLC2008-06-02
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION (K080885)Medacta International S.A.2008-04-28
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT (K072857)Medacta International S.A.2008-02-04
100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES (K070399)Biomet Manufacturing, Inc.2007-05-04
100KGY E-POLY MAXROM ACETABULAR LINERS (K070364)Biomet, Inc.2007-05-03
PORTLAND COBALT CHROME FEMORAL HEAD (K063278)Portland Orthopaedics Limited2007-01-12
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET (K061344)Aesculap, Inc.2006-08-02
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER (K052639)Biomet Manufacturing, Inc.2006-05-03
SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS (K052748)Howmedica Osteonics Corp.2005-12-02
ANTHOLOGY HIP STEM (K052792)Smith & Nephew, Inc.2005-10-07
RINGLOC BI-POLAR ACETABULAR COMPONENT (K051569)Biomet, Inc.2005-09-29
ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS (K050637)Ortho Development Corp.2005-09-23
LEGEND ALL-POLY CUP (K051407)Ortho Development Corp.2005-09-08
TRABECULAR METAL REVISION SHELL LINERS (K051516)Zimmer, Inc.2005-07-27
TAPER 2 POROUS FEMORAL STEM (K050441)Biomet, Inc.2005-06-29
RESTORATION MODULAR SYSTEM (K051363)Howmedica Osteonics Corp.2005-06-23
ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS (K051335)Exactech, Inc.2005-06-21
NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS (K050105)Zimmer, Inc.2005-05-17
MODIFICATION TO: RESTORATION MODULAR SYSTEM (K050138)Howmedica Osteonics Corp.2005-03-21
DEPUY C-STEM AMT HIP PROSTHESIS (K042959)DePuy Orthopaedics, Inc.2004-12-22
IM TOTAL FEMUR (K033871)Biomet, Inc.2004-04-16
FIXION HIP SYSTEM (K032730)Disc-O-Tech Medical Technologies, Ltd.2004-03-26
ATH FEMORAL STEM (K034028)Wrightmedicaltechnologyinc2004-03-11
SC TOTAL HIP SYSTEM (K031474)Orthopedic Alliance, LLC2003-10-15
ESKA MODULAR HIP SYSTEM CEMENTED (K030867)Eska Implants GmbH2003-09-22
36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS (K031730)Howmedica Osteonics Corp.2003-08-29
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS (K032396)Biomet, Inc.2003-08-21
OMNIFIT HFX HIP STEM SERIES (K031744)Howmedica Osteonics Corp.2003-08-08
OXINIUM FEMORAL HEADS (K030766)Smith & Nephew, Inc.2003-07-25
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS (K031734)Biomet, Inc.2003-07-01
PLUS ORTHOPEDICS CEMENTED HIP STEM (K031165)Plus Orthopedics2003-06-06
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32 (K030153)Zimmer, Inc.2003-04-01
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 (K030265)Zimmer, Inc.2003-03-04
SMITH & NEPHEW FEMORAL HEADS (K024340)Smith & Nephew, Inc.2003-02-26
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE (K022799)Howmedica Osteonics Corp.2002-11-21
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS (K023453)DePuy Orthopaedics, Inc.2002-11-13
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM (K023646)Exactech, Inc.2002-11-13
RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM (K023085)Biomet Orthopedics, Inc.2002-10-17
TOTAL HIP FEMORAL HEADS AND LINERS (K022958)Smith & Nephew, Inc.2002-10-02
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING (K022094)Biomet, Inc.2002-07-25
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) (K022077)Howmedica Osteonics Corp.2002-07-25
R120 MODULAR TOTAL HIP SYSTEM (K021822)Osteoimplant Technology, Inc.2002-07-23
OSS LES PROXIMAL FEMORAL COMPONENT (K021380)Biomet, Inc.2002-05-28
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) (K021310)Howmedica Osteonics Corp.2002-05-21
SL-PLUS LATERALIZED STEM (K021178)Plus Orthopedics2002-05-14
SUPER EON PLUS FEMORAL STEMS (K020989)Howmedica Osteonics Corp.2002-04-26
MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) (K020970)Biomet, Inc.2002-04-04
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER (K020291)Exactech, Inc.2002-02-27
PATRIOT PROTRUSIO CAGE (K020076)Biomet Orthopedics, Inc.2002-01-30
AVALON CUP SYSTEM (K011887)Orthopedic Source, Inc.2001-12-27
SUMMIT CEMENTED HIP PROSTHESIS (K013352)DePuy Orthopaedics, Inc.2001-12-17
Next →

Track JDI automatically

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