Atlas FDA

LZO

532 FDA 510(k) clearances · Product code

94 daysmedian time to decision
301 days90th percentile
532clearances measured

FDA profile

Official device name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3353
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 2,199 · 2022: 1,985 · 2023: 2,063 · 2024: 2,586 · 2025: 3,292 · 2026: 1,594
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
MobileLink Acetabular Cup System – 40mm ID Inserts (various) (K261009)Waldemar Link GmbH & Co. KG2026-07-06
Z1 Hip System (K260831)Zimmer, Inc.2026-06-16
Avenir® Müller Stem; Avenir Complete™ Hip System (K260182)Zimmer, Inc.2026-04-27
implantcast Packaging System Update (K260037)Implantcast GmbH2026-03-30
implaFit® short stems (K252401)Implantcast GmbH2026-03-12
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (K253171)Maxx Orthopedics, Inc.2026-01-15
Coated hip implants (K250450)Medacta International S.A.2025-09-19
Longboard Revision Hip Stem (K243021)Signature Orthopaedics Pty, Ltd.2025-08-07
Z1 Hip System (K251906)Zimmer, Inc.2025-07-18
RECLAIM Monobloc Revision Femoral Stem (K251292)Depuy Ireland UC2025-05-23
MobileLink Acetabular Cup System - inhouse coatings (K243927)Waldemar Link GmbH & Co. KG2025-05-16
NEXUS® Hip Stem (K250444)Microport Orthopedics, Inc.2025-05-15
Origin™ Cemented Hip Stem (K243043)Signature Orthopaedics Pty, Ltd.2025-05-02
Zimmer Biomet Ceramic Heads (22.2mm diameter) (K250834)Zimmer Biomet2025-04-18
CATALYSTEM Femoral Stems (K250571)Smith & Nephew, Inc.2025-03-28
Origin™ TT Stem (K243029)Signature Orthopaedics Pty, Ltd.2025-03-11
Versacem Acetabular Shell and Double Mobility HC Liners (K241767)Medacta International S.A.2025-03-06
Biolox® Delta Revision heads (K243809)Limacorporate2025-03-04
ceramys™ femoral head system (K241483)Encore Medical L.P.2025-02-07
Conformity Stem Extension Line, #0 (K243466)United Orthopedic Corporation2025-01-06
BIOCERAM AZUL® HEAD (K243444)Kyocera Corporation2024-12-05
b-ONE® Total Hip System (K240528)B-One Ortho, Corp.2024-11-15
MUTARS® femoral stem cemented 160 mm and 200 mm (K240391)Implantcast GmbH2024-10-24
Conformity Stem Extension Line (K242249)United Orthopedic Corporation2024-08-30
Z1 Cemented Hip System (K241241)Orchard Medical Development, LLC2024-08-27
CATALYSTEM Femoral Stems (K240381)Smith & Nephew, Inc.2024-06-27
EcoFit® short stem cementless cpTi (K240834)Implantcast GmbH2024-06-03
22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads (K234025)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2024-04-24
Ceramic Femoral Head (K240452)Microport Orthopedics, Inc.2024-04-12
28mm/38D MDM X3 Insert for MDM Liner (K233724)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2024-03-11
Z1 Hip System (K233476)Orchard Medical Development2024-02-08
Novae® Dual Mobility System, Hype® Hip System (K223745)Serf2023-12-22
Actinia® hip stems (K232371)Implantcast GmbH2023-10-19
EMPHASYS Femoral Stems (K233233)Depuy Ireland UC2023-10-11
MINIMA S System (K231925)Lima Corporate S.P.A.2023-07-11
BethaLoc® stem cementless HA (K223103)Implantcast GmbH2023-06-20
Xerxes Hip Stem (K231109)Xerxes Arthopedix, LLC2023-06-15
Exactech® Alteon® Short Tapered Wedge (K221323)Exactech, Inc.2023-05-19
BENCOX Delta Option Heads (K223828)Corentec Co., Ltd.2023-03-16
ARTICUL/EZE Ceramic Heads (K222296)Depuy Ireland UC2023-01-06
U-Motion II Acetabular System-Extension line (K221149)United Orthopedic Corporation2023-01-05
DePuy Reclaim Monobloc Revision Femoral Stem (K221462)Depuy Ireland UC2022-10-21
Platform® Acetabular System (K220483)Total Joint Orthopedics, Inc.2022-09-23
SP-CL Hip Stem and LCU Hip System (K213770)Waldemar Link GmbH & Co. KG2022-09-13
implaFit® hip stems (K210678)Implantcast GmbH2022-08-17
DM Converter - TiN coated (K211891)Medacta International S.A.2022-07-22
BiMobile Instruments (for BiMobile Dual Mobility System) (K211567)Waldemar Link GmbH & Co. KG2022-06-03
M-Vizion Monobloc (K212327)Medacta International S.A.2022-05-24
Amis K Long (K220405)Medacta International S.A.2022-04-12
MP Reconstruction System (K213675)Waldemar Link GmbH & Co. KG2022-04-11
Corin MetaFix™ Hip Stem (K212069)Corin U.S.A. Limited2022-04-07
DePuy Corail AMT Hip Prosthesis (K213839)DePuy Orthopaedics, Inc.2022-01-06
Restoration Modular 115mm Conical Distal Stem (K213129)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2021-12-21
Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length (K213580)Total Joint Othopedics, Inc.2021-12-03
Mpres Neck Preserving Stem (K210263)Medacta International S.A.2021-09-22
EMPHASYS Femoral Stems (K211657)Depuy Ireland UC2021-08-05
Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (K201657)Corin, Ltd.2021-07-28
POLARSTEM Cemented Femoral Stem (K203175)Smith & Nephew, Inc.2021-07-22
POLARSTEM Calcar Reamer Guide (K211548)Smith & Nephew, Inc.2021-07-19
BI-MENTUM™ ALTRX® Dual Mobility Liner (K203532)Depuy Ireland UC2021-04-28
Fusion Taper System (K201047)Signature Orthopaedics Pty, Ltd.2021-04-16
KOSMO Femoral Stem (K202768)B-One Ortho, Corp.2021-04-01
EcoFit® Hip System (K203420)Implantcast GmbH2021-02-03
M-Vizion Femoral Revision System Extension (K201471)Medacta International S.A.2021-01-11
Quadra-P (K202730)Medacta International S.A.2020-12-28
Taperloc® Complete Hip Stems (K200196)Biomet Orthopedics2020-12-08
SMS Cementless Stem (K203041)Medacta International S.A.2020-12-02
DePuy Corail AMT Hip Prosthesis (K203167)DePuy Orthopaedics, Inc.2020-11-19
SMS Cementless Stem (K201673)Medacta International S.A.2020-09-18
Spartan Hip Stem (K192883)Signature Orthopaedics Pty, Ltd.2020-08-05
Corin Optimized Positioning System (OPS) Femoral (K193545)Corin USA2020-08-04
Cemented Origin Hip Stem (K201951)Signature Orthopaedics Pty, Ltd.2020-07-31
Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling (K200959)Biomet UK, Ltd.2020-07-29
Cemented TSI Hip Stem (K192024)Signature Orthopaedics Pty, Ltd.2020-06-19
M-Vizion Femoral Revision System Extension (K191816)Medacta International S.A.2020-04-29
PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar (K200007)Microport Orthopedics, Inc.2020-04-25
Zimmer Hip Joint Replacement (K200112)Zimmer GmbH2020-04-10
Zimmer M/L Taper Hip Prosthesis (K192660)Zimmer, Inc.2020-02-28
Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads (K192683)Biomet UK, Ltd.2020-02-27
MobiliT Cup (K191831)Corin U.S.A. Limited2020-01-16
AMIStem-C (K193433)Medacta International S.A.2020-01-09
Quadra-P (K192827)Medacta International S.A.2020-01-06
Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem (K193050)Zimmer GmbH2019-12-26
Acetabular Bone Screws (for MobileLink Acetabular Cup System) (K192559)Waldemar Link GmbH & Co. KG2019-12-21
Avenir Complete Hip System, Size 0 Coxa Vara (K192189)Zimmer, Inc.2019-12-18
Avenir Muller Stem, Avenir Cemented Hip Stem (K193030)Zimmer GmbH2019-12-06
DePuy Corail AMT Hip Prosthesis (K192946)DePuy Orthopaedics, Inc.2019-11-26
AMIStem-P Short Neck (K192126)Medacta International S.A.2019-11-22
DePuy Corail AMT Hip Prosthesis (K190344)Depuy(Ireland)2019-11-01
Exactech Alteon Modular Dual Mobility (MDM) System (K190890)Exactech, Inc.2019-10-22
PROFEMUR TL2 Stems (K191632)Microport Orthopedics, Inc.2019-10-07
BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System (K192416)Zimmer GmbH2019-10-01
MiniMAX (K192352)Medacta International S.A.2019-09-27
BIOLOX CONTOURA Ceramic Femoral Head (K191399)Total Joint Othopedics, Inc.2019-08-28
Signature Ceramic Femoral Head (K190704)Signature Orthopaedics Pty, Ltd.2019-08-28
Libertas – Taper Uncemented Femoral Stem (K183684)Maxx Orthopedics, Inc.2019-08-23
Conformity Stem (K183312)United Orthopedic Corporation2019-08-08
Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System (K191781)Zimmer GmbH2019-08-06
BiMobile Dual Mobility System - E-Dur Inserts (K190535)Waldemar Link GmbH & Co. KG2019-08-06
Revival Modular Hip Stem (K191374)Corin U.S.A. Limited2019-07-22
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