Atlas FDA

LPH

563 FDA 510(k) clearances · Product code

90 daysmedian time to decision
322 days90th percentile
563clearances measured

FDA profile

Official device name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3358
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 5,978 · 2022: 5,223 · 2023: 5,346 · 2024: 5,627 · 2025: 6,245 · 2026: 3,093
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TRIVANCE™ Hip Stem (K254043)Globus Medical, Inc.2026-08-04
Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component (K261624)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2026-07-10
iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating (K243192)Nextstep Arthopedix, LLC2026-06-05
Taperloc® Complete Hip Stem (K251270)Biomet, Inc.2026-05-19
G7® Revision Acetabular System (K252623)Zimmer, Inc.2026-02-04
Mpact 3D Metal Implants Extension – DMLS Technology (K251043)Medacta International S.A.2026-01-28
Velora Acetabular System (K252067)Restor3D, Inc.2025-12-05
TaperSet™ Hip System (K252846)Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics2025-11-20
EMPOWR Acetabular® Liner Extension (K251833)Encore Medical L.P.2025-11-12
ArTT Augments and Buttresses and Bone Screws (K251718)Lima Corporate S.P.A.2025-08-29
Stryker and Serf hip devices (K250989)Howmedica Osteonics Corp (Dba Stryker Orthopaedics)2025-07-25
ONVOY™ Acetabular System (K243456)Globus Medical, Inc.2025-06-06
Trinity EVO Acetabular Shell (K242744)Corin U.S.A. Limited2025-06-05
Mpact 3D Metal Augments II (K242232)Medacta International S.A.2025-04-23
Initia T3 Acetabular Hemispherical Shell System (K242045)Kyocera Medical Technologies, Inc.2025-04-10
Stryker Orthopaedics Hip Devices Labeling Update (K243784)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2025-02-06
EMPHASYS Acetabular System (K243977)Depuy Ireland UC2025-01-22
Pantheon Proximal Femur Reconstruction (PFR) System (K241059)Adler Ortho S.P.A2025-01-13
MobileLink Acetabular Cup System - Line Extension (Multiple) (K241636)Waldemar Link GmbH & Co. KG2024-11-08
Legend® Acetabular Shell (K242833)Ortho Development Corp.2024-10-11
EMPHASYS Acetabular Shell with RapiTite HA (K242084)Depuy Ireland UC2024-10-07
OR3O Dual Mobility System (K242375)Smith & Nephew, Inc.2024-10-07
Ethylene Oxide Sterilization Supplier Change for MPO Hips (K240046)Microport Orthopedics2024-04-18
EMPHASYS™ Dual Mobility System (K231522)Depuy Ireland UC2024-02-15
Stryker Orthopaedics Hip Systems Labeling Update (K233498)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2023-12-21
OR3O Dual Mobility Liners (K232667)Smith & Nephew, Inc.2023-10-27
Mpact Extension (K230011)Medacta International S.A.2023-09-20
DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System (K232556)Depuy Ireland UC2023-09-20
Latitud™ Hip Replacement System (K222436)Meril Healthcare Pvt. , Ltd.2023-05-09
LINK MobileLink Acetabular Cup System (K222066)Waldemar Link GmbH & Co. KG2023-04-14
BENCOX Mirabo Z Cup Cortinium (K223223)Corentec Co., Ltd.2023-02-27
EMPOWR™ blade stem (K223779)Encore Medical, LLC2023-02-13
My3D® Personalized Pelvic Reconstruction (K223348)Onkos Surgical, Inc.2023-01-30
CoCr Head (K211047)Zimmer GmbH2023-01-10
United U2 femoral head, 22mm delta ceramic head (K221675)United Orthopedic Corporation2022-11-04
ONVOY Acetabular System (K213842)Globus Medical, Inc.2022-10-03
Mg-PSZ Ceramic Femoral Head (K220336)Theken Companies2022-09-30
EMPHASYS Acetabular System (K221636)Depuy Ireland UC2022-09-06
OR3O Dual Mobility System (K220959)Smith & Nephew, Inc.2022-08-18
My3D® Personalized Pelvic Reconstruction (K212815)Onkos Surgical2022-07-06
Smith & Nephew Hip Systems (K211176)Smith & Nephew, Inc.2022-07-01
DePuy 3D Additive TriFlange Acetabular Cup (K201348)Depuy International, Ltd.2022-06-16
BENCOX Mirabo Z Cup Cortinium (K210614)Corentec Co., Ltd.2022-05-24
BENCOX Mirabo Cup System (K220468)Corentec Co., Ltd.2022-05-18
Biocore9 Acetabular Cup System (K212761)Biocore9, LLC2022-05-17
Acetabular Dome Hole Plug (K220376)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022-03-09
Restoration® Modular Hip System (K212187)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022-03-01
R3 Large Head Liners (K211330)Smith & Nephew, Inc.2022-01-19
Mpact® 3D Metal Implants - DMLS Technology (K202568)Medacta International S.A.2021-12-20
E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS (K200011)Microport Orthopedics, Inc.2021-10-01
Bencox THR System (K211866)Corentec Co., Ltd.2021-07-14
Provident II Hip Stems (K201733)Globus Medical, Inc.2021-07-14
LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters (K200607)Waldemar Link GmbH & Co. KG2021-05-28
MPACT Extension (K200391)Medacta International S.A.2021-04-28
Restoration Anatomic Shell (K210893)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2021-04-22
EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing (K203557)Encore Medical L.P.2021-02-10
ACTIS Duofix Hip Prosthesis (K202472)DePuy Orthopaedics, Inc.2020-10-21
Cordera Hip System (K202484)Conformis, Inc.2020-09-24
DePuy PINNACLE Dual Mobility Liner (K200854)Depuy Ireland UC2020-09-11
Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head (K191708)Signature Orthopaedics Pty, Ltd.2020-08-14
Delta Multihole TT Pro Acetabular System (K200656)Lima Corporate S.P.A.2020-07-08
Restoration® Modular Hip System (K193233)Howmedica Osteonics Corp. (Aka Stryker Orthopaedics)2020-05-27
KeYi Total Hip System (K191826)Beijing Keyi Medical Device Technology Co., Ltd.2020-05-14
Precision Casting Solutions Total Hip System (K192450)Precision Casting Solution, LLC2019-12-17
Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings (K190656)Zimmer, Inc.2019-12-06
G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene (K190660)Zimmer, Inc.2019-12-05
Pinnacle Duofix HA Acetabular Cup Prosthesis (K192919)DePuy Orthopaedics, Inc.2019-11-26
Conformis Hip System (K192198)Conformis, Inc.2019-11-06
Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head (K183457)Zimmer, Inc.2019-11-05
Delta Multihole TT Pro Acetabular System (K191622)Lima Corporate S.P.A.2019-11-01
OR3O Dual Mobility System (K191002)Smith & Nephew, Inc.2019-10-31
REDAPT Blade Augments (K190847)Smith & Nephew, Inc.2019-10-25
Trident II Acetabular System (K191358)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019-10-24
iNSitu Total Hip System (K192071)Theken Companies, LLC2019-08-30
Conformis BeneFIT Hip System (K190904)Conformis, Inc.2019-08-28
iNSitu Total Hip System (K191936)Thecken Companies, LLC2019-08-20
Medtronic Total Hip Arthroplasty System (K183129)Medtronic Advanced Energy2019-07-26
MicroPort CoCr Femoral Heads (K190123)Microport Orthopedics, Inc.2019-07-15
DJO Acetabular System (K190057)Encore Medical L.P.2019-06-07
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling (K182678)Zimmer, Inc.2019-05-31
Bencox Mirabo Cup Multi Hole (K182221)Corentec Co., Ltd.2019-04-01
MPACT Extension (K183582)Medacta International S.A.2019-03-21
Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (K182468)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2019-03-19
Alteon Acetabular Cup System (K182502)Exactech, Inc.2019-03-13
Provident II Hip Stem (K190276)Stelkast, Inc.2019-03-08
Delta TT Pro (K182099)Lima Corporate S.P.A.2018-12-26
REDAPT Modular Acetabular Shell (K182109)Smith & Nephew, Inc.2018-11-16
REDAPT Porous Acetabular Shell (K181366)Smith & Nephew, Inc.2018-09-24
Latitud Hip Replacement System (K172857)Meril Healthcare Pvt. , Ltd.2018-07-19
Prime Acetabular Cup System (K180798)Microport Orthopedics, Inc.2018-07-09
Trinity PLUS Acetabular Shell (K172551)Corin U.S.A. Limited2018-06-15
Legend Acetabular Liners (K173951)Ortho Development Corporation2018-05-30
Mpact® 3D Metal™ Implants and Augments 3D Metal™ (K171966)Medacta International S.A.2018-03-27
Bone Screws 6.5mm (K172456)Lima Corporate S.P.A.2018-01-04
Birmingham Hip (BH) Dual Mobility Insert (K171934)Smith & Nephew, Inc.2017-11-30
Smith & Nephew, Inc. REDAPT Augments (K171073)Smith & Nephew, Inc.2017-11-21
UTS Stem (K172251)United Orthopedic Corporation2017-10-24
Bencox Mirabo Cup System (K172806)Corentec Co., Ltd.2017-10-17
Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem (K172684)Smith & Nephew, Inc.2017-10-03
Trident® II Acetabular System (K171768)Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics2017-10-02
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