LPHFDA Class 2 · 21 CFR 888.3358 · implantable
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device family · Orthopedic
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
565
Manufacturers
52
Flagged signals
18
Adverse-event reports
83,558
Code matrix
| FDA product code | LPH |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2015 | 3 | 665.0 | 1,382 |
| Other | 2013 | 71 | 24.9 | 1,601 |
| Other | 2011 | 71 | 24.9 | 1,601 |
| Other | 2010 | 57 | 19.9 | 1,007 |
| Other | 2012 | 56 | 19.6 | 970 |
| Other | 2014 | 5 | 17.0 | 60 |
| Other | 2013 | 3 | 12.9 | 22 |
| Other | 2010 | 3 | 10.2 | 17 |
| Other | 2012 | 3 | 10.2 | 17 |
| Other | 2014 | 20 | 7.0 | 97 |
| Other | 2013 | 12 | 4.2 | 26 |
| Other | 2015 | 8 | 2.8 | 8 |
| Other | 2009 | 8 | 2.7 | 7 |
| Injury | 2013 | 14 | 2.6 | 20 |
| Other | 2010 | 7 | 2.4 | 5 |
| Injury | 2013 | 8 | 2.3 | 8 |
| Injury | 2013 | 15 | 2.3 | 16 |
| Injury | 2021 | 13 | 2.3 | 13 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 83,558 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Zimmer, Inc. | 47 | 2026 | — |
| Biomet, Inc. | 43 | 2016 | — |
| Smith & Nephew, Inc. | 32 | 2024 | — |
| DEPUY ORTHOPAEDICS, INC. | 32 | 2020 | — |
| Depuy, Inc. | 27 | 2004 | — |
| Exactech, Inc. | 19 | 2019 | — |
| Howmedica Corp. | 17 | 1998 | — |
| Encore Orthopedics, Inc. | 16 | 2002 | — |
| Howmedica Osteonics Corp. | 15 | 2012 | — |
| Encore Medical L.P. | 12 | 2025 | — |
| CORENTEC CO., LTD. | 12 | 2023 | — |
| Wrightmedicaltechnologyinc | 12 | 2006 | — |
| Implex Corp. | 10 | 2002 | — |
| United Orthopedic Corporation | 10 | 2022 | — |
| Sulzer Orthopedics, Inc. | 10 | 2001 | — |
| Ortho Development Corp. | 9 | 2024 | — |
| Lima Corporate S.P.A. | 8 | 2025 | — |
| Osteonics Corp. | 7 | 1998 | — |
| Stelkast Company | 7 | 2001 | — |
| Omni Life Science, Inc. | 7 | 2012 | — |
| Medacta International S.A. | 7 | 2026 | — |
| CONSENSUS ORTHOPEDICS, INC. | 7 | 2014 | — |
| Stryker Orthopaedics | 6 | 2016 | — |
| DePuy Ireland UC | 6 | 2025 | — |
| Intermedics Orthopedics | 5 | 1997 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
G7® Revision Acetabular System · Zimmer, Inc.510(k) · 2026-02-04
Mpact 3D Metal Implants Extension DMLS Technology · Medacta International S.A.510(k) · 2026-01-28
Velora Acetabular System · Restor3D, Inc.510(k) · 2025-12-05
TaperSet Hip System · Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics510(k) · 2025-11-20
EMPOWR Acetabular® Liner Extension · Encore Medical L.P.510(k) · 2025-11-12
ArTT Augments and Buttresses and Bone Screws · Lima Corporate S.P.A.510(k) · 2025-08-29
Stryker and Serf hip devices · Howmedica Osteonics Corp (Dba Stryker Orthopaedics)510(k) · 2025-07-25
ONVOY Acetabular System · Globus Medical, Inc.510(k) · 2025-06-06
Trinity EVO Acetabular Shell · Corin U.S.A. Limited510(k) · 2025-06-05
Mpact 3D Metal Augments II · Medacta International S.A.510(k) · 2025-04-23
Initia T3 Acetabular Hemispherical Shell System · Kyocera Medical Technologies, Inc.510(k) · 2025-04-10
Stryker Orthopaedics Hip Devices Labeling Update · Howmedica Osteonics Corp., Dba Stryker Orthopaedics510(k) · 2025-02-06
EMPHASYS Acetabular System · Depuy Ireland UC510(k) · 2025-01-22
Pantheon Proximal Femur Reconstruction (PFR) System · Adler Ortho S.P.A510(k) · 2025-01-13
MobileLink Acetabular Cup System - Line Extension (Multiple) · Waldemar Link GmbH & Co. KG510(k) · 2024-11-08
Legend® Acetabular Shell · Ortho Development Corp.510(k) · 2024-10-11
EMPHASYS Acetabular Shell with RapiTite HA · Depuy Ireland UC510(k) · 2024-10-07
OR3O Dual Mobility System · Smith & Nephew, Inc.510(k) · 2024-10-07
Ethylene Oxide Sterilization Supplier Change for MPO Hips · Microport Orthopedics510(k) · 2024-04-18
EMPHASYS Dual Mobility System · Depuy Ireland UC510(k) · 2024-02-15
Stryker Orthopaedics Hip Systems Labeling Update · Howmedica Osteonics Corp., Dba Stryker Orthopaedics510(k) · 2023-12-21
OR3O Dual Mobility Liners · Smith & Nephew, Inc.510(k) · 2023-10-27
DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System · Depuy Ireland UC510(k) · 2023-09-20
Mpact Extension · Medacta International S.A.510(k) · 2023-09-20
Latitud Hip Replacement System · Meril Healthcare Pvt. , Ltd.510(k) · 2023-05-09
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.