FDA Product Code
FDA Product Code LPH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3358
510(k) Clearances — 565 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261453 | G7® Acetabular System | Zimmer Biomet | 2026-09-23 | Traditional | PDF ↗ |
| K253630 | Mpact 3D Metal Foam | Medacta International S.A. | 2026-08-28 | Traditional | PDF ↗ |
| K254043 | TRIVANCE Hip Stem | Globus Medical, Inc. | 2026-08-04 | Traditional | PDF ↗ |
| K261624 | 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 | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-07-10 | Traditional | PDF ↗ |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating | Nextstep Arthopedix, LLC | 2026-06-05 | Traditional | PDF ↗ |
| K251270 | Taperloc® Complete Hip Stem | Biomet, Inc. | 2026-05-19 | Traditional | PDF ↗ |
| K252623 | G7® Revision Acetabular System | Zimmer, Inc. | 2026-02-04 | Traditional | PDF ↗ |
| K251043 | Mpact 3D Metal Implants Extension DMLS Technology | Medacta International S.A. | 2026-01-28 | Traditional | PDF ↗ |
| K252067 | Velora Acetabular System | Restor3D, Inc. | 2025-12-05 | Traditional | PDF ↗ |
| K252846 | TaperSet Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | 2025-11-20 | Special | PDF ↗ |
| K251833 | EMPOWR Acetabular® Liner Extension | Encore Medical L.P. | 2025-11-12 | Traditional | PDF ↗ |
| K251718 | ArTT Augments and Buttresses and Bone Screws | Lima Corporate S.P.A. | 2025-08-29 | Traditional | PDF ↗ |
| K250989 | Stryker and Serf hip devices | Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | 2025-07-25 | Traditional | PDF ↗ |
| K243456 | ONVOY Acetabular System | Globus Medical, Inc. | 2025-06-06 | Traditional | PDF ↗ |
| K242744 | Trinity EVO Acetabular Shell | Corin U.S.A. Limited | 2025-06-05 | Traditional | PDF ↗ |
| K242232 | Mpact 3D Metal Augments II | Medacta International S.A. | 2025-04-23 | Traditional | PDF ↗ |
| K242045 | Initia T3 Acetabular Hemispherical Shell System | Kyocera Medical Technologies, Inc. | 2025-04-10 | Traditional | PDF ↗ |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 | Traditional | PDF ↗ |
| K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025-01-22 | Special | PDF ↗ |
| K241059 | Pantheon Proximal Femur Reconstruction (PFR) System | Adler Ortho S.P.A | 2025-01-13 | Traditional | PDF ↗ |
| K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) | Waldemar Link GmbH & Co. KG | 2024-11-08 | Traditional | PDF ↗ |
| K242833 | Legend® Acetabular Shell | Ortho Development Corp. | 2024-10-11 | Special | PDF ↗ |
| K242375 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2024-10-07 | Traditional | PDF ↗ |
| K242084 | EMPHASYS Acetabular Shell with RapiTite HA | Depuy Ireland UC | 2024-10-07 | Traditional | PDF ↗ |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | Microport Orthopedics | 2024-04-18 | Traditional | PDF ↗ |
| K231522 | EMPHASYS Dual Mobility System | Depuy Ireland UC | 2024-02-15 | Traditional | PDF ↗ |
| K233498 | Stryker Orthopaedics Hip Systems Labeling Update | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023-12-21 | Traditional | PDF ↗ |
| K232667 | OR3O Dual Mobility Liners | Smith & Nephew, Inc. | 2023-10-27 | Traditional | PDF ↗ |
| K230011 | Mpact Extension | Medacta International S.A. | 2023-09-20 | Traditional | PDF ↗ |
| K232556 | DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System | Depuy Ireland UC | 2023-09-20 | Special | PDF ↗ |
| K222436 | Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. | 2023-05-09 | Traditional | PDF ↗ |
| K222066 | LINK MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 2023-04-14 | Traditional | PDF ↗ |
| K223223 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2023-02-27 | Special | PDF ↗ |
| K223779 | EMPOWR blade stem | Encore Medical, LLC | 2023-02-13 | Traditional | PDF ↗ |
| K223348 | My3D® Personalized Pelvic Reconstruction | Onkos Surgical, Inc. | 2023-01-30 | Traditional | PDF ↗ |
| K211047 | CoCr Head | Zimmer GmbH | 2023-01-10 | Traditional | PDF ↗ |
| K221675 | United U2 femoral head, 22mm delta ceramic head | United Orthopedic Corporation | 2022-11-04 | Special | PDF ↗ |
| K213842 | ONVOY Acetabular System | Globus Medical, Inc. | 2022-10-03 | Traditional | PDF ↗ |
| K220336 | Mg-PSZ Ceramic Femoral Head | Theken Companies | 2022-09-30 | Special | PDF ↗ |
| K221636 | EMPHASYS Acetabular System | Depuy Ireland UC | 2022-09-06 | Traditional | PDF ↗ |
| K220959 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2022-08-18 | Traditional | PDF ↗ |
| K212815 | My3D® Personalized Pelvic Reconstruction | Onkos Surgical | 2022-07-06 | Traditional | PDF ↗ |
| K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | 2022-07-01 | Traditional | PDF ↗ |
| K201348 | DePuy 3D Additive TriFlange Acetabular Cup | Depuy International, Ltd. | 2022-06-16 | Traditional | PDF ↗ |
| K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | 2022-05-24 | Traditional | PDF ↗ |
| K220468 | BENCOX Mirabo Cup System | Corentec Co., Ltd. | 2022-05-18 | Special | PDF ↗ |
| K212761 | Biocore9 Acetabular Cup System | Biocore9, LLC | 2022-05-17 | Traditional | PDF ↗ |
| K220376 | Acetabular Dome Hole Plug | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-03-09 | Special | PDF ↗ |
| K212187 | Restoration® Modular Hip System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-03-01 | Traditional | PDF ↗ |
| K211330 | R3 Large Head Liners | Smith & Nephew, Inc. | 2022-01-19 | Traditional | PDF ↗ |
| K202568 | Mpact® 3D Metal Implants - DMLS Technology | Medacta International S.A. | 2021-12-20 | Traditional | PDF ↗ |
| K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS | Microport Orthopedics, Inc. | 2021-10-01 | Traditional | PDF ↗ |
| K211866 | Bencox THR System | Corentec Co., Ltd. | 2021-07-14 | Special | PDF ↗ |
| K201733 | Provident II Hip Stems | Globus Medical, Inc. | 2021-07-14 | Special | PDF ↗ |
| K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters | Waldemar Link GmbH & Co. KG | 2021-05-28 | Traditional | PDF ↗ |
| K200391 | MPACT Extension | Medacta International S.A. | 2021-04-28 | Traditional | PDF ↗ |
| K210893 | Restoration Anatomic Shell | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2021-04-22 | Special | PDF ↗ |
| K203557 | EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing | Encore Medical L.P. | 2021-02-10 | Traditional | PDF ↗ |
| K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020-10-21 | Special | PDF ↗ |
| K202484 | Cordera Hip System | Conformis, Inc. | 2020-09-24 | Special | PDF ↗ |
| K200854 | DePuy PINNACLE Dual Mobility Liner | Depuy Ireland UC | 2020-09-11 | Traditional | PDF ↗ |
| K191708 | Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head | Signature Orthopaedics Pty, Ltd. | 2020-08-14 | Traditional | PDF ↗ |
| K200656 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.P.A. | 2020-07-08 | Traditional | PDF ↗ |
| K193233 | Restoration® Modular Hip System | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | 2020-05-27 | Special | PDF ↗ |
| K191826 | KeYi Total Hip System | Beijing Keyi Medical Device Technology Co., Ltd. | 2020-05-14 | Traditional | PDF ↗ |
| K192450 | Precision Casting Solutions Total Hip System | Precision Casting Solution, LLC | 2019-12-17 | Traditional | PDF ↗ |
| K190656 | Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings | Zimmer, Inc. | 2019-12-06 | Traditional | PDF ↗ |
| K190660 | G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene | Zimmer, Inc. | 2019-12-05 | Traditional | PDF ↗ |
| K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2019-11-26 | Special | PDF ↗ |
| K192198 | Conformis Hip System | Conformis, Inc. | 2019-11-06 | Special | PDF ↗ |
| K183457 | Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head | Zimmer, Inc. | 2019-11-05 | Traditional | PDF ↗ |
| K191622 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.P.A. | 2019-11-01 | Traditional | PDF ↗ |
| K191002 | OR3O Dual Mobility System | Smith & Nephew, Inc. | 2019-10-31 | Traditional | PDF ↗ |
| K190847 | REDAPT Blade Augments | Smith & Nephew, Inc. | 2019-10-25 | Traditional | PDF ↗ |
| K191358 | Trident II Acetabular System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019-10-24 | Special | PDF ↗ |
| K192071 | iNSitu Total Hip System | Theken Companies, LLC | 2019-08-30 | Special | PDF ↗ |
| K190904 | Conformis BeneFIT Hip System | Conformis, Inc. | 2019-08-28 | Traditional | PDF ↗ |
| K191936 | iNSitu Total Hip System | Thecken Companies, LLC | 2019-08-20 | Special | PDF ↗ |
| K183129 | Medtronic Total Hip Arthroplasty System | Medtronic Advanced Energy | 2019-07-26 | Traditional | PDF ↗ |
| K190123 | MicroPort CoCr Femoral Heads | Microport Orthopedics, Inc. | 2019-07-15 | Traditional | PDF ↗ |
| K190057 | DJO Acetabular System | Encore Medical L.P. | 2019-06-07 | Traditional | PDF ↗ |
| K182678 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling | Zimmer, Inc. | 2019-05-31 | Traditional | PDF ↗ |
| K182221 | Bencox Mirabo Cup Multi Hole | Corentec Co., Ltd. | 2019-04-01 | Special | PDF ↗ |
| K183582 | MPACT Extension | Medacta International S.A. | 2019-03-21 | Traditional | PDF ↗ |
| K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2019-03-19 | Traditional | PDF ↗ |
| K182502 | Alteon Acetabular Cup System | Exactech, Inc. | 2019-03-13 | Traditional | PDF ↗ |
| K190276 | Provident II Hip Stem | Stelkast, Inc. | 2019-03-08 | Special | PDF ↗ |
| K182099 | Delta TT Pro | Lima Corporate S.P.A. | 2018-12-26 | Traditional | PDF ↗ |
| K182109 | REDAPT Modular Acetabular Shell | Smith & Nephew, Inc. | 2018-11-16 | Traditional | PDF ↗ |
| K181366 | REDAPT Porous Acetabular Shell | Smith & Nephew, Inc. | 2018-09-24 | Traditional | PDF ↗ |
| K172857 | Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. | 2018-07-19 | Traditional | PDF ↗ |
| K180798 | Prime Acetabular Cup System | Microport Orthopedics, Inc. | 2018-07-09 | Traditional | PDF ↗ |
| K172551 | Trinity PLUS Acetabular Shell | Corin U.S.A. Limited | 2018-06-15 | Traditional | PDF ↗ |
| K173951 | Legend Acetabular Liners | Ortho Development Corporation | 2018-05-30 | Special | PDF ↗ |
| K171966 | Mpact® 3D Metal Implants and Augments 3D Metal | Medacta International S.A. | 2018-03-27 | Traditional | PDF ↗ |
| K172456 | Bone Screws 6.5mm | Lima Corporate S.P.A. | 2018-01-04 | Special | PDF ↗ |
| K171934 | Birmingham Hip (BH) Dual Mobility Insert | Smith & Nephew, Inc. | 2017-11-30 | Traditional | PDF ↗ |
| K171073 | Smith & Nephew, Inc. REDAPT Augments | Smith & Nephew, Inc. | 2017-11-21 | Traditional | PDF ↗ |
| K172251 | UTS Stem | United Orthopedic Corporation | 2017-10-24 | Traditional | PDF ↗ |
| K172806 | Bencox Mirabo Cup System | Corentec Co., Ltd. | 2017-10-17 | Special | PDF ↗ |
Product code LPH · Class II · Orthopedic. Data: openFDA.