FDA Product Code
FDA Product Code JDI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3350
510(k) Clearances — 565 records · page 2 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K013352 | SUMMIT CEMENTED HIP PROSTHESIS | DePuy Orthopaedics, Inc. | 2001-12-17 | Traditional | PDF ↗ |
| K013350 | MODIFICATION TO DEPUY C-STEM SYSTEM | DePuy Orthopaedics, Inc. | 2001-11-07 | Special | PDF ↗ |
| K012961 | SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM | Sulzer Orthopedics, Inc. | 2001-10-18 | Special | PDF ↗ |
| K011774 | R120 MODULAR TOTAL HIP SYSTEM | Osteoimplant Technology, Inc. | 2001-09-05 | Traditional | PDF ↗ |
| K012493 | ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 | Exactech, Inc. | 2001-08-29 | Special | PDF ↗ |
| K011715 | MACROPORE IB RESORBABLE PLUG | Macropore Biosurgery, Inc. | 2001-08-27 | Traditional | PDF ↗ |
| K012019 | COLOR BUFFED (CB) DDH FEMORAL STEM | Biomet, Inc. | 2001-07-20 | Special | PDF ↗ |
| K011455 | BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER | Biomet, Inc. | 2001-07-18 | Traditional | PDF ↗ |
| K012026 | TRIDENT ALL POLY CUP | Howmedica Osteonics Corp. | 2001-07-18 | Special | PDF ↗ |
| K011623 | EXETER HIP SYSTEM WITH V40 TAPER | Howmedica Osteonics Corp. | 2001-06-15 | Special | PDF ↗ |
| K011367 | EXCEL FRACTURE CEMENTED HIP STEM | DePuy Orthopaedics, Inc. | 2001-06-15 | Traditional | PDF ↗ |
| K011218 | ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 | Exactech, Inc. | 2001-05-16 | Special | PDF ↗ |
| K010529 | TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA | Medtronic Sofamor Danek USA, Inc. | 2001-04-27 | Special | PDF ↗ |
| K010757 | LFIT V40 FEMORAL HEAD COMPONENTS | Howmedica Osteonics Corp. | 2001-04-11 | Special | PDF ↗ |
| K010310 | MODIFICATION TO TRIDENT ALL POLY CUP | Howmedica Osteonics Corp. | 2001-03-20 | Special | PDF ↗ |
| K003975 | BAUMER CEMENTED HIP PROSTHESIS | Baumer, S.A | 2001-03-19 | Traditional | PDF ↗ |
| K003976 | BAUMER MULLER HIP PROSTHESIS | Baumer, S.A | 2001-03-19 | Traditional | PDF ↗ |
| K003666 | TAPER-FIT TOTAL HIP SYSTEM | Corin USA | 2001-02-08 | Traditional | PDF ↗ |
| K001956 | TRIDENT ALL POLY CUP | Howmedica Osteonics Corp. | 2000-12-11 | Traditional | PDF ↗ |
| K003421 | DEPUY C-STEM SYSTEM | DePuy Orthopaedics, Inc. | 2000-12-01 | Special | PDF ↗ |
| K002757 | ONCOLOGY SALVAGE SYSTEM | Biomet, Inc. | 2000-11-24 | Traditional | PDF ↗ |
| K002324 | MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA | Sulzermedica | 2000-08-24 | Special | PDF ↗ |
| K001759 | HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ | Implex Corp. | 2000-08-24 | Traditional | PDF ↗ |
| K001571 | BAUMER FEMORAL HEAD | Baumer, S.A | 2000-08-04 | Traditional | PDF ↗ |
| K002106 | NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER | Biomet, Inc. | 2000-07-27 | Special | PDF ↗ |
| K001932 | TORNIER CEMENT RESTRICTOR | Tornier | 2000-07-20 | Special | PDF ↗ |
| K001376 | TI-MAX PROTRUSIO CAGE | Biomet, Inc. | 2000-07-20 | Traditional | PDF ↗ |
| K001078 | SULZER ORTHOPEDICS MS-30 FEMORAL STEM | Sulzer Orthopedics, Inc. | 2000-06-23 | Traditional | PDF ↗ |
| K001733 | ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES | Zimmer, Inc. | 2000-06-20 | Traditional | PDF ↗ |
| K000817 | OMEGA II MODULAR TOTAL HIP SYSTEM | Osteoimplant Technology, Inc. | 2000-06-08 | Traditional | PDF ↗ |
| K001335 | ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED | Exactech, Inc. | 2000-05-18 | Special | PDF ↗ |
| K990330 | CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ | Implex Corp. | 2000-03-01 | Traditional | PDF ↗ |
| K000254 | PAR 5 ACETABULAR COMPONENT | Biomet, Inc. | 2000-02-07 | Special | PDF ↗ |
| K994007 | MALLORY/HEAD SMOOTH FEMORAL COMPONENT | Biomet, Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K993713 | RIM-FIX, ACETABULAR CUP | Surgical Implants, Inc. | 2000-01-28 | Traditional | PDF ↗ |
| K992409 | THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ | Implex Corp. | 1999-10-08 | Traditional | PDF ↗ |
| K992153 | PE-PLUS ACETABULAR CUP | Plus Orthopedics | 1999-09-23 | Traditional | PDF ↗ |
| K992903 | COLOR BUFFED CEMENTED FEMORAL | Biomet, Inc. | 1999-09-17 | Special | PDF ↗ |
| K992490 | B2C HIP SYSTEM | Lepine Groupe Spa. | 1999-08-19 | Traditional | PDF ↗ |
| K991869 | COBREX HIP STEM, MODEL 01-128-XXXXX | Implex Corp. | 1999-07-14 | Abbreviated | PDF ↗ |
| K991622 | 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER | Stelkast Company | 1999-07-14 | Traditional | PDF ↗ |
| K992058 | BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM | Biomet, Inc. | 1999-07-01 | Special | PDF ↗ |
| K991987 | COLOR BUFFED ANSWER CEMENTED FEMORAL | Biomet, Inc. | 1999-06-28 | Special | PDF ↗ |
| K991538 | OPERA CUPFLANGED ACETABULAR COMPONENTS | Smith & Nephew, Inc., Orthopaedic Div. | 1999-06-03 | Abbreviated | PDF ↗ |
| K991227 | 8MM FORGED CEMENTED STEM | Encore Orthopedics, Inc. | 1999-06-01 | Traditional | PDF ↗ |
| K990821 | PROVIDENCE CUP SYSTEM | Biopro, Inc. | 1999-04-29 | Traditional | PDF ↗ |
| K984227 | OMEGA II MODULAR TOTAL HIP SYSTEM | Osteoimplant Technology, Inc. | 1999-04-08 | Traditional | PDF ↗ |
| K990369 | SYNERGY CEMENTED HIP STEM | Smith & Nephew, Inc. | 1999-03-12 | Abbreviated | PDF ↗ |
| K990032 | MODULAR PROTUSIO CUP | Biomet, Inc. | 1999-02-18 | Traditional | PDF ↗ |
| K984154 | APF POROUS COATED LINE EXTENSION | Biomet, Inc. | 1999-02-11 | Traditional | PDF ↗ |
| K980926 | DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION | Howmedica Corp. | 1998-12-16 | Traditional | PDF ↗ |
| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | Howmedica Corp. | 1998-12-11 | Traditional | PDF ↗ |
| K983226 | OSTEONICS X CEMENTED HIP STEM SERIES | Osteonics Corp. | 1998-12-04 | Traditional | PDF ↗ |
| K983128 | IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY | Implex Corp. | 1998-12-03 | Traditional | PDF ↗ |
| K983710 | 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH | Biomet, Inc. | 1998-12-02 | Traditional | PDF ↗ |
| K983136 | DEPUY LUSTER STEM | DePuy Orthopaedics, Inc. | 1998-11-25 | Traditional | PDF ↗ |
| K982963 | POLYMER THREADED ANCHOR / SUTURE COMBINATION | Orthopaedic Biosystems, Ltd. | 1998-11-20 | Traditional | PDF ↗ |
| K982918 | DEPUY C-STEM SYSTEM | DePuy Orthopaedics, Inc. | 1998-10-05 | Traditional | PDF ↗ |
| K982670 | CONTEMPORARY ACETABULAR COMPONENT | Howmedica Corp. | 1998-10-02 | Traditional | PDF ↗ |
| K982598 | OTI FEMORAL LOCK TOTAL HIP SYSTEM | Osteoimplant Technology, Inc. | 1998-10-02 | Traditional | PDF ↗ |
| K974685 | OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS | Osteonics Corp. | 1998-09-22 | Traditional | PDF ↗ |
| K981855 | PRINCE MEDICAL CEMENT PLUG | Prince Medical, Inc. | 1998-08-10 | Traditional | PDF ↗ |
| K980813 | RELIANCE LONG STEM FEMORAL COMPONENTS | Howmedica, Inc. | 1998-06-26 | Traditional | PDF ↗ |
| K980843 | EXETER INTRAMEDULLARY BONE PLUG | Howmedica, Inc. | 1998-06-02 | Traditional | PDF ↗ |
| K980794 | DUAL LOCK HIP STEM | Depuy, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K980513 | ARTICUL/EZE FEMORAL HEADS | DePuy Orthopaedics, Inc. | 1998-04-14 | Traditional | PDF ↗ |
| K980486 | IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM | Implex Corp. | 1998-04-14 | Traditional | PDF ↗ |
| K980286 | ULTIMA ACETABULAR ROOF REINFORCEMENT RING | Johnson & Johnson Professionals, Inc. | 1998-04-03 | Traditional | PDF ↗ |
| K974558 | SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM | Biomet, Inc. | 1998-03-04 | Traditional | PDF ↗ |
| K972791 | ENCORE LINEAR HIP | Encore Orthopedics, Inc. | 1998-01-12 | Traditional | PDF ↗ |
| K973809 | FOUNDATION FRACTURE STEM | Encore Orthopedics, Inc. | 1998-01-02 | Traditional | PDF ↗ |
| K974054 | DISTAL CENTRALIZER, EXETER II HIP SYSTEM | Howmedica, Inc. | 1997-12-23 | Traditional | PDF ↗ |
| K973453 | TORNIER CEMENT RESTRICTOR | Tornier | 1997-12-09 | Traditional | PDF ↗ |
| K971681 | SMC FEMORAL HIP COMPONENT | Signal Medical Corp. | 1997-12-04 | Traditional | PDF ↗ |
| K973296 | EXTEND HIP STEM | Wrightmedicaltechnologyinc | 1997-11-24 | Traditional | PDF ↗ |
| K972995 | THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM | Corin USA | 1997-11-10 | Traditional | PDF ↗ |
| K972961 | STELKAST BIPOLAR SYSTEM | Stelkast Company | 1997-11-04 | Traditional | PDF ↗ |
| K972928 | KERBOULL CROSS | Howmedica, Inc. | 1997-11-03 | Traditional | PDF ↗ |
| K972792 | DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS | Howmedica Corp. | 1997-10-16 | Traditional | PDF ↗ |
| K972641 | DUAL OFFSET PERFECTA IMC HIP STEM | Wrightmedicaltechnologyinc | 1997-10-09 | Traditional | PDF ↗ |
| K972460 | OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION) | Osteonics Corp. | 1997-09-25 | Traditional | PDF ↗ |
| K972435 | ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM | Johnson & Johnson Professionals, Inc. | 1997-09-11 | Traditional | PDF ↗ |
| K971890 | RECOVERY PROTRUSIO CAGE | Biomet, Inc. | 1997-08-07 | Traditional | PDF ↗ |
| K971705 | IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED | Implex Corp. | 1997-08-06 | Traditional | PDF ↗ |
| K971581 | HEMISPHERE CEMENTED CUP | Ortho Development Corp. | 1997-07-18 | Traditional | PDF ↗ |
| K963612 | DURATION STABILIZED UHMWPE | Howmedica Corp. | 1997-06-11 | Traditional | PDF ↗ |
| K970697 | OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM | Osteonics Corp. | 1997-04-24 | Traditional | PDF ↗ |
| K970194 | PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT | Stelkast Company | 1997-04-14 | Traditional | PDF ↗ |
| K965019 | THE C-FIT FEMORAL HIP SYSTEM | Corin USA | 1997-03-25 | Traditional | PDF ↗ |
| K964003 | METAGEN ALL POLY ACETABULAR CUP SYSTEM | Metagen, LLC | 1997-03-21 | Traditional | PDF ↗ |
| K970351 | GLOBAL TAPER SPECTRON HIP STEMS | Smith & Nephew, Inc., Orthopaedic Div. | 1997-02-28 | Traditional | PDF ↗ |
| K964795 | CEMENTED CALCAR REPLACEMENT FEMORAL STEM | Johnson & Johnson Professionals, Inc. | 1997-02-19 | Traditional | PDF ↗ |
| K964655 | UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE | Howmedica Corp. | 1997-02-06 | Traditional | PDF ↗ |
| K962468 | HEDROCEL ACETABULAR RESTRICTOR | Implex Corp. | 1997-02-03 | Traditional | PDF ↗ |
| K963671 | OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP | Osteonics Corp. | 1997-02-03 | Traditional | PDF ↗ |
| K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA | Intermedics Orthopedics | 1997-01-16 | Traditional | PDF ↗ |
| K963109 | HERITAGE HIP SYSTEM | Zimmer, Inc. | 1997-01-09 | Traditional | PDF ↗ |
| K964218 | PERFECTA PLASMA SPRAY HIP STEM | Wrightmedicaltechnologyinc | 1997-01-08 | Traditional | PDF ↗ |
| K964262 | EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD | Exactech, Inc. | 1996-12-27 | Traditional | PDF ↗ |
| K963486 | REVISION HIP SYSTEM | Smith & Nephew Richards, Inc. | 1996-11-27 | Traditional | PDF ↗ |
Product code JDI · Class II · Orthopedic. Data: openFDA.