Atlas FDA

KWZ

34 FDA 510(k) clearances · Product code

104 daysmedian time to decision
207 days90th percentile
34clearances measured

FDA profile

Official device name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3310
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 216 · 2022: 158 · 2023: 164 · 2024: 145 · 2025: 194 · 2026: 93
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
Mpact Constrained Liner (K241461)Medacta International S.A.2025-07-31
PINNACLETM Constrained Acetabular Liners (K240639)Depuy Ireland UC2024-04-04
Smith & Nephew, Inc. R3™ Constrained Liner (K162641)Smith & Nephew, Inc.2017-06-19
EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt (K163497)Encore Medical L.P.2017-03-02
EXPRT Revision Hip System (K161610)Encore Medical L.P.2016-11-09
SMITH & NEPHEW R3 CONSTRAINED LINERS (K122139)Smith & Nephew, Inc.2012-10-16
SMITH & NEPHEW RJ CONSTRAINED LINERS (K111635)Smith & Nephew, Inc.2011-09-09
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS (K101730)Zimmer, Inc.2010-12-03
R3 CONSTRAINED LINER, CONSTRAINED LINER (K083566)Smith & Nephew, Inc.2009-03-03
TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER (K072121)Zimmer, Inc.2008-01-07
DEPUY SPA POROUS COATED PROXIMAL SLEEVE (K071059)DePuy Orthopaedics, Inc.2007-11-09
EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS (K071676)Exactech, Inc.2007-07-19
TRILOGY LONGEVITY CONSTRAINED LINER (K071718)Zimmer, Inc.2007-07-13
MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS (K071117)DePuy Orthopaedics, Inc.2007-05-18
SERIES II CONSTRAINED ACETABULAR LINERS (K063552)Howmedica Osteonics Corp.2007-03-08
SYSTEM 12 CONSTRAINED ACETABULAR LINERS (K063550)Howmedica Osteonics Corp.2007-03-08
PCA CONSTRAINED ACETABULAR LINERS (K063445)Howmedica Osteonics Corp.2007-03-08
TRIDENT CONSTRAINED ACETABULAR INSERT (K061654)Howmedica Osteonics Corp.2006-07-07
PINNACLE CONSTRAINED ACETABULAR LINERS (K052079)DePuy Orthopaedics, Inc.2005-10-21
PINNACLE CONSTRAINED ACETABULAR LINERS (K043058)Depuy, Inc.2005-03-14
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS (K040601)Exactech, Inc.2004-10-04
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (K040225)Osteoimplant Technology, Inc.2004-05-06
REFLECTION CONSTRAINED LINER (K033442)Smith & Nephew, Inc.2003-11-26
EPSILON DURASUL CONSTRAINED ACETABULAR LINER (K030923)Centerpulse Orthopedics, Inc.2003-10-03
CONSTRAINED LINER (K023794)Encore Medical L.P.2003-04-01
FREEDOM CONSTRAINED LINERS (K030047)Biomet, Inc.2003-01-23
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES (K021826)Zimmer, Inc.2002-12-20
REFLECTION CONSTRAINED LINER (K021803)Smith & Nephew, Inc.2002-12-19
RINGLOC CONSTRAINED LINERS II (K021728)Biomet, Inc.2002-10-25
RINGLOC CONSTRAINED LINERS (K021661)Biomet Orthopedics, Inc.2002-10-25
RINGLOC CONSTRAINED LINER (K950202)Biomet, Inc.1995-05-15
OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT (K890197)Osteonics Corp.1989-04-07
S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP (K870271)Joint Medical Products Corp.1987-04-20
HCL ACETABULAR COMPONENTS (K803192)Osteonics Corp.1981-01-23

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