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 |
|---|---|---|---|
| Sep 23, 2026 | K261453 | G7® Acetabular System Zimmer Biomet | LPH |
| Aug 28, 2026 | K253630 | Mpact 3D Metal Foam Medacta International S.A., CH | LPH |
| Aug 4, 2026 | K254043 | TRIVANCE Hip Stem Globus Medical, Inc. | LPH |
| Jul 10, 2026 | K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH |
| Jun 5, 2026 | K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating Nextstep Arthopedix, LLC | LPH |
| May 19, 2026 | K251270 | Taperloc® Complete Hip Stem Biomet, Inc. | LPH |
| Feb 4, 2026 | K252623 | G7® Revision Acetabular System Zimmer, Inc. | LPH |
| Jan 28, 2026 | K251043 | Mpact 3D Metal Implants Extension DMLS Technology Medacta International S.A., CH | LPH |
| Dec 5, 2025 | K252067 | Velora Acetabular System Restor3D, Inc. | LPH |
| Nov 20, 2025 | K252846 | TaperSet Hip System Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | LPH |
| Nov 12, 2025 | K251833 | EMPOWR Acetabular® Liner Extension Encore Medical L.P. | LPH |
| Aug 29, 2025 | K251718 | ArTT Augments and Buttresses and Bone Screws Lima Corporate S.P.A., IT | LPH |
| Jul 25, 2025 | K250989 | Stryker and Serf hip devices Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | LPH |
| Jun 6, 2025 | K243456 | ONVOY Acetabular System Globus Medical, Inc. | LPH |
| Jun 5, 2025 | K242744 | Trinity EVO Acetabular Shell Corin U.S.A. Limited | LPH |
| Apr 23, 2025 | K242232 | Mpact 3D Metal Augments II Medacta International S.A., CH | LPH |
| Apr 10, 2025 | K242045 | Initia T3 Acetabular Hemispherical Shell System Kyocera Medical Technologies, Inc. | LPH |
| Feb 6, 2025 | K243784 | Stryker Orthopaedics Hip Devices Labeling Update Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH |
| Jan 22, 2025 | K243977 | EMPHASYS Acetabular System Depuy Ireland UC, IE | LPH |
| Jan 13, 2025 | K241059 | Pantheon Proximal Femur Reconstruction (PFR) System Adler Ortho S.P.A, IT | LPH |
| Nov 8, 2024 | K241636 | MobileLink Acetabular Cup System - Line Extension (Multiple) Waldemar Link GmbH & Co. KG, DE | LPH |
| Oct 11, 2024 | K242833 | Legend® Acetabular Shell Ortho Development Corp. | LPH |
| Oct 7, 2024 | K242375 | OR3O Dual Mobility System Smith & Nephew, Inc. | LPH |
| Oct 7, 2024 | K242084 | EMPHASYS Acetabular Shell with RapiTite HA Depuy Ireland UC, IE | LPH |
| Apr 18, 2024 | K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips Microport Orthopedics | LPH |
| Feb 15, 2024 | K231522 | EMPHASYS Dual Mobility System Depuy Ireland UC, IE | LPH |
| Dec 21, 2023 | K233498 | Stryker Orthopaedics Hip Systems Labeling Update Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH |
| Oct 27, 2023 | K232667 | OR3O Dual Mobility Liners Smith & Nephew, Inc. | LPH |
| Sep 20, 2023 | K232556 | DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System Depuy Ireland UC, IE | LPH |
| Sep 20, 2023 | K230011 | Mpact Extension Medacta International S.A., CH | LPH |
| May 9, 2023 | K222436 | Latitud Hip Replacement System Meril Healthcare Pvt. , Ltd., IN | LPH |
| Apr 14, 2023 | K222066 | LINK MobileLink Acetabular Cup System Waldemar Link GmbH & Co. KG, DE | LPH |
| Feb 27, 2023 | K223223 | BENCOX Mirabo Z Cup Cortinium Corentec Co., Ltd., KR | LPH |
| Feb 13, 2023 | K223779 | EMPOWR blade stem Encore Medical, LLC | LPH |
| Jan 30, 2023 | K223348 | My3D® Personalized Pelvic Reconstruction Onkos Surgical, Inc. | LPH |
| Jan 10, 2023 | K211047 | CoCr Head Zimmer GmbH, CH | LPH |
| Nov 4, 2022 | K221675 | United U2 femoral head, 22mm delta ceramic head United Orthopedic Corporation, TW | LPH |
| Oct 3, 2022 | K213842 | ONVOY Acetabular System Globus Medical, Inc. | LPH |
| Sep 30, 2022 | K220336 | Mg-PSZ Ceramic Femoral Head Theken Companies | LPH |
| Sep 6, 2022 | K221636 | EMPHASYS Acetabular System Depuy Ireland UC, IE | LPH |
| Aug 18, 2022 | K220959 | OR3O Dual Mobility System Smith & Nephew, Inc. | LPH |
| Jul 6, 2022 | K212815 | My3D® Personalized Pelvic Reconstruction Onkos Surgical | LPH |
| Jul 1, 2022 | K211176 | Smith & Nephew Hip Systems Smith & Nephew, Inc. | LPH |
| Jun 16, 2022 | K201348 | DePuy 3D Additive TriFlange Acetabular Cup Depuy International, Ltd., GB | LPH |
| May 24, 2022 | K210614 | BENCOX Mirabo Z Cup Cortinium Corentec Co., Ltd., KR | LPH |
| May 18, 2022 | K220468 | BENCOX Mirabo Cup System Corentec Co., Ltd., KR | LPH |
| May 17, 2022 | K212761 | Biocore9 Acetabular Cup System Biocore9, LLC | LPH |
| Mar 9, 2022 | K220376 | Acetabular Dome Hole Plug Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH |
| Mar 1, 2022 | K212187 | Restoration® Modular Hip System Howmedica Osteonics Corp., Dba Stryker Orthopaedics | LPH |
| Jan 19, 2022 | K211330 | R3 Large Head Liners Smith & Nephew, Inc. | LPH |
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