Product code KWL
- Device name
- Prosthesis, Hip, Hemi-, Femoral, Metal
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3360
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | Depuy Ireland UC | 2026-05-15 |
| K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2025-12-23 |
| K252326 | InterSpace GV Hip Spacer | Tecres S.P.A. | 2025-08-06 |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | Biocomposites, Ltd. | 2025-06-12 |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+V | Heraeus Medical GmbH | 2024-02-15 |
| K222632 | UHR Bipolar Implants, Restoration GAP II Implants | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-10-21 |
| K192995 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2020-01-10 |
| K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | 2019-08-23 |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Osteoremedies, LLC | 2018-08-29 |
| K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | 2018-02-22 |
| K143184 | Evolve UniPolar Head | Signature Orthopaedics Pty, Ltd. | 2015-03-17 |
| K112470 | 2GC HIP/KNEE MODULAR SPACER | Mandell Horwitz Consultants, LLC | 2012-04-05 |
| K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011-09-20 |
| K111911 | CORIN OPTIMOM MODULAR HEAD | Corin USA | 2011-08-04 |
| K062273 | SPACER-G TEMPORARY HIP PROSTHESIS | Tecres S.P.A. | 2008-05-22 |
| K071471 | CORIN ADAPTOR SLEEVE | Howmedica Osteonics Corp. | 2007-09-10 |
| K063791 | CORIN UNIPOLAR MODULAR HEAD | Corin USA | 2007-04-03 |
| K062408 | SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD | Smith & Nephew, Inc. | 2006-09-12 |
| K061243 | SMITH & NEPHEW MODULAR FEMORAL HEAD | Smith & Nephew, Inc. | 2006-07-17 |
| K042973 | SOLITUDE UNIPOLAR HEAD | Ortho Development Corp. | 2005-01-27 |
| K031841 | SPACER G TEMPORARY HIP PROSTHESIS | Exactech, Inc. | 2004-01-22 |
| K030972 | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) | Disc-O-Tech Medical Technologies, Ltd. | 2003-05-30 |
| K030205 | CONSENSUS UNIPOLAR HEAD, COCR | Hayes Medical, Inc. | 2003-04-01 |
| K014226 | UNITRAX MODULAR UNIPOLAR SYSTEM | Howmedica Osteonics Corp. | 2002-01-25 |
| K992570 | UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE | Howmedica Osteonics Corp. | 1999-09-01 |
| K990309 | PLUS FRACTURE HEAD PROSTHESIS | Plus Orthopedics | 1999-03-15 |
| K984585 | OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE | Osteonics Corp. | 1999-02-24 |
| K984028 | THE NEW BIO-MOORE ENDO HEADS | Biomet, Inc. | 1999-01-19 |
| K981451 | ARGOMEDICAL BIPOLAR SYSTEM | Stelkast Company | 1998-08-21 |
| K974807 | OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM | Osteonics Corp. | 1998-03-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613153071600 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153073000 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072997 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072980 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072959 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072928 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072911 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072904 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072898 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072874 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153072867 | Trident | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071655 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071648 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071631 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071617 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071273 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071587 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071518 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071440 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071433 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071419 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071396 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071389 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071372 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071365 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071358 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071334 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071327 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071310 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613153071280 | Restoration | Howmedica Osteonics Corp. | 2015-09-24 |