Panels › Orthopedic › Product code LPH · Class 2
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Regulation 888.3358
11510(k)s in 12 months (565 all time)
3recalls in 12 months (299 all time)
269recalls that name a 510(k)
Top companies in LPH
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 46 | 56 |
| Biomet, Inc. | 44 | 43 |
| DePuy Orthopaedics, Inc. | 33 | 23 |
| Zimmer Biomet | 1 | 48 |
| Howmedica Osteonics | 16 | 31 |
| Exactech, Inc. | 19 | 26 |
| Smith & Nephew, Inc. | 32 | 4 |
| Depuy, Inc. | 24 | 0 |
| Encore Medical L.P. | 13 | 11 |
| Howmedica Corp. | 18 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 20, 2021 | K202568 | Mpact® 3D Metal Implants - DMLS Technology Medacta International S.A., CH | LPH |
| Oct 1, 2021 | K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS Microport Orthopedics, Inc. | LPH |
| Jul 14, 2021 | K211866 | Bencox THR System Corentec Co., Ltd., KR | LPH |
| Jul 14, 2021 | K201733 | Provident II Hip Stems Globus Medical, Inc. | LPH |
| May 28, 2021 | K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters Waldemar Link GmbH & Co. KG, DE | LPH |
| Apr 28, 2021 | K200391 | MPACT Extension Medacta International S.A., CH | LPH |
| Apr 22, 2021 | K210893 | Restoration Anatomic Shell Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH |
| Feb 10, 2021 | K203557 | EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing Encore Medical L.P. | LPH |
| Oct 21, 2020 | K202472 | ACTIS Duofix Hip Prosthesis DePuy Orthopaedics, Inc. | LPH |
| Sep 24, 2020 | K202484 | Cordera Hip System Conformis, Inc. | LPH |
| Sep 11, 2020 | K200854 | DePuy PINNACLE Dual Mobility Liner Depuy Ireland UC, IE | LPH |
| Aug 14, 2020 | K191708 | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head Signature Orthopaedics Pty, Ltd., AU | LPH |
| Jul 8, 2020 | K200656 | Delta Multihole TT Pro Acetabular System Lima Corporate S.P.A., IT | LPH |
| May 27, 2020 | K193233 | Restoration® Modular Hip System Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | LPH |
| May 14, 2020 | K191826 | KeYi Total Hip System Beijing Keyi Medical Device Technology Co., Ltd., CN | LPH |
| Dec 17, 2019 | K192450 | Precision Casting Solutions Total Hip System Precision Casting Solution, LLC | LPH |
| Dec 6, 2019 | K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings Zimmer, Inc. | LPH |
| Dec 5, 2019 | K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslin Zimmer, Inc. | LPH |
| Nov 26, 2019 | K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis DePuy Orthopaedics, Inc. | LPH |
| Nov 6, 2019 | K192198 | Conformis Hip System Conformis, Inc. | LPH |
| Nov 5, 2019 | K183457 | Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head Zimmer, Inc. | LPH |
| Nov 1, 2019 | K191622 | Delta Multihole TT Pro Acetabular System Lima Corporate S.P.A., IT | LPH |
| Oct 31, 2019 | K191002 | OR3O Dual Mobility System Smith & Nephew, Inc. | LPH |
| Oct 25, 2019 | K190847 | REDAPT Blade Augments Smith & Nephew, Inc. | LPH |
| Oct 24, 2019 | K191358 | Trident II Acetabular System Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH |
| Aug 30, 2019 | K192071 | iNSitu Total Hip System Theken Companies, LLC | LPH |
| Aug 28, 2019 | K190904 | Conformis BeneFIT Hip System Conformis, Inc. | LPH |
| Aug 20, 2019 | K191936 | iNSitu Total Hip System Thecken Companies, LLC | LPH |
| Jul 26, 2019 | K183129 | Medtronic Total Hip Arthroplasty System Medtronic Advanced Energy | LPH |
| Jul 15, 2019 | K190123 | MicroPort CoCr Femoral Heads Microport Orthopedics, Inc. | LPH |
| Jun 7, 2019 | K190057 | DJO Acetabular System Encore Medical L.P. | LPH |
| May 31, 2019 | K182678 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling Zimmer, Inc. | LPH |
| Apr 1, 2019 | K182221 | Bencox Mirabo Cup Multi Hole Corentec Co., Ltd., KR | LPH |
| Mar 21, 2019 | K183582 | MPACT Extension Medacta International S.A., CH | LPH |
| Mar 19, 2019 | K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH |
| Mar 13, 2019 | K182502 | Alteon Acetabular Cup System Exactech, Inc. | LPH |
| Mar 8, 2019 | K190276 | Provident II Hip Stem Stelkast, Inc. | LPH |
| Dec 26, 2018 | K182099 | Delta TT Pro Lima Corporate S.P.A., IT | LPH |
| Nov 16, 2018 | K182109 | REDAPT Modular Acetabular Shell Smith & Nephew, Inc. | LPH |
| Sep 24, 2018 | K181366 | REDAPT Porous Acetabular Shell Smith & Nephew, Inc. | LPH |
| Jul 19, 2018 | K172857 | Latitud Hip Replacement System Meril Healthcare Pvt. , Ltd., IN | LPH |
| Jul 9, 2018 | K180798 | Prime Acetabular Cup System Microport Orthopedics, Inc. | LPH |
| Jun 15, 2018 | K172551 | Trinity PLUS Acetabular Shell Corin U.S.A. Limited | LPH |
| May 30, 2018 | K173951 | Legend Acetabular Liners Ortho Development Corporation | LPH |
| Mar 27, 2018 | K171966 | Mpact® 3D Metal Implants and Augments 3D Metal Medacta International S.A., CH | LPH |
| Jan 4, 2018 | K172456 | Bone Screws 6.5mm Lima Corporate S.P.A., IT | LPH |
| Nov 30, 2017 | K171934 | Birmingham Hip (BH) Dual Mobility Insert Smith & Nephew, Inc. | LPH |
| Nov 21, 2017 | K171073 | Smith & Nephew, Inc. REDAPT Augments Smith & Nephew, Inc. | LPH |
| Oct 24, 2017 | K172251 | UTS Stem United Orthopedic Corporation, TW | LPH |
| Oct 17, 2017 | K172806 | Bencox Mirabo Cup System Corentec Co., Ltd., KR | LPH |
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