FDA Product Code
FDA Product Code KWL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3360
510(k) Clearances — 108 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular Cup | Osteoremedies, LLC | 2026-07-24 | Special | PDF ↗ |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement | Depuy Ireland UC | 2026-05-15 | Traditional | PDF ↗ |
| K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2025-12-23 | Special | PDF ↗ |
| K252326 | InterSpace GV Hip Spacer | Tecres S.P.A. | 2025-08-06 | Special | PDF ↗ |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | Biocomposites, Ltd. | 2025-06-12 | Traditional | PDF ↗ |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+V | Heraeus Medical GmbH | 2024-02-15 | Traditional | PDF ↗ |
| K222632 | UHR Bipolar Implants, Restoration GAP II Implants | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-10-21 | Traditional | PDF ↗ |
| K192995 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | 2020-01-10 | Special | PDF ↗ |
| K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | 2019-08-23 | Special | PDF ↗ |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Osteoremedies, LLC | 2018-08-29 | Traditional | PDF ↗ |
| K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | 2018-02-22 | Traditional | PDF ↗ |
| K143184 | Evolve UniPolar Head | Signature Orthopaedics Pty, Ltd. | 2015-03-17 | Traditional | PDF ↗ |
| K112470 | 2GC HIP/KNEE MODULAR SPACER | Mandell Horwitz Consultants, LLC | 2012-04-05 | Traditional | PDF ↗ |
| K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | 2011-09-20 | Traditional | PDF ↗ |
| K111911 | CORIN OPTIMOM MODULAR HEAD | Corin USA | 2011-08-04 | Special | PDF ↗ |
| K062273 | SPACER-G TEMPORARY HIP PROSTHESIS | Tecres S.P.A. | 2008-05-22 | Traditional | PDF ↗ |
| K071471 | CORIN ADAPTOR SLEEVE | Howmedica Osteonics Corp. | 2007-09-10 | Traditional | PDF ↗ |
| K063791 | CORIN UNIPOLAR MODULAR HEAD | Corin USA | 2007-04-03 | Traditional | PDF ↗ |
| K062408 | SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD | Smith & Nephew, Inc. | 2006-09-12 | Special | PDF ↗ |
| K061243 | SMITH & NEPHEW MODULAR FEMORAL HEAD | Smith & Nephew, Inc. | 2006-07-17 | Abbreviated | PDF ↗ |
| K042973 | SOLITUDE UNIPOLAR HEAD | Ortho Development Corp. | 2005-01-27 | Traditional | PDF ↗ |
| K031841 | SPACER G TEMPORARY HIP PROSTHESIS | Exactech, Inc. | 2004-01-22 | Traditional | PDF ↗ |
| K030972 | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) | Disc-O-Tech Medical Technologies, Ltd. | 2003-05-30 | Special | PDF ↗ |
| K030205 | CONSENSUS UNIPOLAR HEAD, COCR | Hayes Medical, Inc. | 2003-04-01 | Traditional | PDF ↗ |
| K014226 | UNITRAX MODULAR UNIPOLAR SYSTEM | Howmedica Osteonics Corp. | 2002-01-25 | Special | PDF ↗ |
| K992570 | UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE | Howmedica Osteonics Corp. | 1999-09-01 | Special | PDF ↗ |
| K990309 | PLUS FRACTURE HEAD PROSTHESIS | Plus Orthopedics | 1999-03-15 | Traditional | PDF ↗ |
| K984585 | OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE | Osteonics Corp. | 1999-02-24 | Traditional | PDF ↗ |
| K984028 | THE NEW BIO-MOORE ENDO HEADS | Biomet, Inc. | 1999-01-19 | Traditional | PDF ↗ |
| K981451 | ARGOMEDICAL BIPOLAR SYSTEM | Stelkast Company | 1998-08-21 | Traditional | PDF ↗ |
| K974807 | OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM | Osteonics Corp. | 1998-03-16 | Traditional | PDF ↗ |
| K973614 | FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES | Encore Orthopedics, Inc. | 1997-12-18 | Traditional | PDF ↗ |
| K965198 | ULTIMA TPS CEMENTED STEM | Johnson & Johnson International | 1997-07-23 | Traditional | PDF ↗ |
| K965156 | ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES | Johnson & Johnson Professionals, Inc. | 1997-01-24 | Traditional | PDF ↗ |
| K962646 | PRIME MODULAR ENDO HEAD | Orthopaedic Innovations, Inc. | 1996-09-23 | Traditional | PDF ↗ |
| K960538 | OPTEON UNIPOLAR | Exactech, Inc. | 1996-03-27 | Traditional | PDF ↗ |
| K955385 | JOHNSON & JOHNSON AUSTIN MOORE STEM | Johnson & Johnson Professionals, Inc. | 1996-01-30 | Traditional | PDF ↗ |
| K954534 | OSTEONICS UNIPOLAR ENDO HEAD | Osteonics Corp. | 1995-11-30 | Traditional | PDF ↗ |
| K954077 | UNITRAX V40 MODULAR ADAPTOR | Howmedica Corp. | 1995-11-15 | Traditional | PDF ↗ |
| K943778 | OSTEONICS RESTORATION CEMENTED HIP STEM SERIES | Osteonics Corp. | 1995-08-14 | Traditional | PDF ↗ |
| K950563 | ULTIMA AUGMENTED UHMWPE CUP | Johnson & Johnson Professionals, Inc. | 1995-06-07 | Traditional | PDF ↗ |
| K951355 | LINK SADDLE PROTHESIS | Turnkey Intergration USA, Inc. | 1995-05-25 | Traditional | PDF ↗ |
| K931752 | CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION | Corin Orthopedic Products | 1994-10-07 | Traditional | PDF ↗ |
| K931753 | CORIN THOMPSON PROSTHESIS, MODIFICATION | Corin Orthopedic Products | 1994-10-07 | Traditional | PDF ↗ |
| K940190 | ULTIMA UNIPOLAR MODULAR HEAD | Johnson & Johnson Orthopaedics, Inc. | 1994-09-29 | Traditional | PDF ↗ |
| K934353 | ZIRCONIUM ALLOY UNI-POLAR HEAD | Smith & Nephew Richards, Inc. | 1994-04-25 | Traditional | PDF ↗ |
| K924050 | TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT | Orthomet, Inc. | 1993-08-25 | Traditional | PDF ↗ |
| K926120 | CONTOUR FEMORAL HIP STEM WITH POROCOAT | Depuy, Inc. | 1993-03-31 | Traditional | PDF ↗ |
| K924379 | ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM | Johnson & Johnson Orthopaedics, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K922146 | OSTRONCS HEMI-HIP STEM SERIES | Osteonics Corp. | 1992-08-11 | Traditional | PDF ↗ |
| K920193 | OMNIFLEX M-HA HIP STEM SERIES | Stryker Corp. | 1992-06-08 | Traditional | PDF ↗ |
| K920231 | OMNIFIT M-HA HIP STEM SERIES | Stryker Corp. | 1992-06-08 | Traditional | PDF ↗ |
| K915868 | PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT | Orthomet, Inc. | 1992-03-23 | Traditional | PDF ↗ |
| K903877 | MTS FEMORAL HIP SYSTEM | 3M Company | 1991-01-18 | Traditional | PDF ↗ |
| K902365 | MODULAR UNIPOLAR SYSTEM | Howmedica Corp. | 1991-01-11 | Traditional | PDF ↗ |
| K905349 | AUSTIN MOORE TYPE HIP PROTHESIS | O'Tec Corp. | 1990-12-11 | Traditional | PDF ↗ |
| K905334 | THOMPSON TYPE HIP PROSTHESIS | O'Tec Corp. | 1990-12-11 | Traditional | PDF ↗ |
| K904119 | PROFILE COLLARED HIP PROSTHESIS | Depuy, Inc. | 1990-10-11 | Traditional | PDF ↗ |
| K903885 | KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD | Kinamed, Inc. | 1990-09-13 | Traditional | PDF ↗ |
| K903884 | KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD | Kinamed, Inc. | 1990-09-13 | Traditional | PDF ↗ |
| K903240 | THOMPSON TYPE HIS PROSTHESIS | Onyx Medical Corp. | 1990-07-30 | Traditional | PDF ↗ |
| K903241 | AUSTIN MOORE TYPE HIP PROSTHESIS | Onyx Medical Corp. | 1990-07-30 | Traditional | PDF ↗ |
| K896853 | PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA | Howmedica Corp. | 1990-05-02 | Traditional | PDF ↗ |
| K900638 | P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT | Johnson & Johnson International | 1990-04-30 | Traditional | PDF ↗ |
| K896105 | EVOLUTION HIP SYSTEM | Dow Corning Wright | 1989-12-29 | Traditional | PDF ↗ |
| K895886 | BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM | Biopro, Inc. | 1989-12-01 | Traditional | PDF ↗ |
| K891482 | AML(R) COLLARLESS LATERALIZED FEMORAL HIP | Depuy, Inc. | 1989-05-16 | Traditional | PDF ↗ |
| K884889 | MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. | Protek, Inc. | 1989-02-27 | Traditional | PDF ↗ |
| K884789 | NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI | Protek, Inc. | 1989-02-08 | Traditional | PDF ↗ |
| K883179 | HIP FRACTURE STEM SYSTEM | Howmedica Corp. | 1988-09-22 | Traditional | PDF ↗ |
| K874915 | ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS | Orthomet, Inc. | 1988-02-03 | Traditional | PDF ↗ |
| K872535 | BIOPRO FEMORAL HIP COMPONENT | Biopro, Inc. | 1987-08-26 | Traditional | PDF ↗ |
| K872776 | PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT | Depuy, Inc. | 1987-08-24 | Traditional | PDF ↗ |
| K872025 | POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS | Depuy, Inc. | 1987-08-18 | Traditional | PDF ↗ |
| K872878 | TRI-LOCK MODIFIED FEMORAL PROSTHESIS | Depuy, Inc. | 1987-08-07 | Traditional | PDF ↗ |
| K871656 | ORTHOMET AUSTIN-MOORE SYSTEM | Orthomet, Inc. | 1987-06-09 | Traditional | PDF ↗ |
| K864085 | BROOKER BIO-GROOVE FEMORAL COMPONENT | Biomet, Inc. | 1987-01-28 | Traditional | PDF ↗ |
| K854791 | BIO-FIT HIP SYSTEM | Richards Medical Co., Inc. | 1986-02-27 | Traditional | PDF ↗ |
| K855228 | FEMORAL HEMI-HIP PROSTHESES | Orthopaedic Device Corp. | 1986-02-11 | Traditional | PDF ↗ |
| K853662 | MUELLER CURVED STEM HEMI-PROSTHESIS | Protek, Inc. | 1985-09-24 | Traditional | PDF ↗ |
| K852584 | POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT | Biomet, Inc. | 1985-08-15 | Traditional | PDF ↗ |
| K844818 | NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS | Osteonics Corp. | 1985-07-30 | Traditional | PDF ↗ |
| K852420 | BTM TOTAL HIP SYSTEM | Kirschner Medical Corp. | 1985-06-28 | Traditional | PDF ↗ |
| K850928 | V.E.P. HIP -VARIABLE ENDO-PROSTHESIS | Unitas Ent. | 1985-05-28 | Traditional | PDF ↗ |
| K843995 | TF-II HIP PROSTHESIS | Dow Corning Corp. Healthcare Industries Materials | 1985-04-23 | Traditional | PDF ↗ |
| K845025 | AUSTIN-MOORE MODULAR HIP PROSTHESIS | Biomet, Inc. | 1985-04-19 | Traditional | PDF ↗ |
| K844488 | MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS | Mecron Medical Products, Inc. | 1985-03-12 | Traditional | PDF ↗ |
| K844486 | MECRON MRC-HEADLESS FEMORAL COMPONENT | Mecron Medical Products, Inc. | 1985-02-19 | Traditional | PDF ↗ |
| K844487 | MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR | Mecron Medical Products, Inc. | 1985-02-19 | Traditional | PDF ↗ |
| K842559 | WHITESIDE ORTHOLOC TOTAL HIP FEMORAL | Dow Corning Corp. Healthcare Industries Materials | 1984-12-20 | Traditional | PDF ↗ |
| K842465 | UNILOC | American Ortomed Corp. | 1984-11-19 | Traditional | PDF ↗ |
| K842234 | NEW JERSEY FEMORAL STEM | Endomedics, Inc. | 1984-07-20 | Traditional | PDF ↗ |
| K841437 | PENNSYLVANIA HOSPITAL HIP SYS | Biomet, Inc. | 1984-06-25 | Traditional | PDF ↗ |
| K833599 | MODIFIED HPS HIP PROSTHESIS | Depuy, Inc. | 1984-03-19 | Traditional | PDF ↗ |
| K833403 | BDH UNIPOLAR FEMORAL COMPONENT A2 | Carbomedics, Inc. | 1984-01-10 | Traditional | PDF ↗ |
| K831851 | STRAIGHT STEM FEMORAL HEAD PROSTHESIS | Proteck, Inc. | 1983-10-06 | Traditional | PDF ↗ |
| K831420 | HIP PROSTHESIS -VARIOUS | The Oec Group | 1983-09-20 | Traditional | PDF ↗ |
| K830307 | AUFRANC-TURNER ATS TOTAL HIP SYSTEM | Howmedica Corp. | 1983-03-10 | Traditional | PDF ↗ |
| K823051 | METAL KNEE & HIP PROSTHESIS | Zimmer, Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K822321 | IOI 32 TM FEMORAL COMPONENT | Intermedics Orthopedics | 1982-08-20 | Traditional | PDF ↗ |
Product code KWL · Class II · Orthopedic. Data: openFDA.