FDA Product Code
FDA Product Code MBH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3565
510(k) Clearances — 146 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K093405 | PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES | Wrightmedicaltechnologyinc | 2010-05-25 | Traditional | PDF ↗ |
| K100897 | LEGION POROUS + HA TIBIAL BASEPLATES | Smith & Nephew, Inc. | 2010-05-13 | Special | PDF ↗ |
| K093533 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 | Materialise NV | 2010-02-17 | Traditional | PDF ↗ |
| K091543 | LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS | Smith & Nephew, Inc. | 2009-12-21 | Abbreviated | PDF ↗ |
| K083782 | REGENEREX PATELLA COMPONENTS | Biomet Manufacturing Corp | 2009-04-03 | Traditional | PDF ↗ |
| K081479 | ADVANCE A-CLASS TIBIAL INSERT | Wrightmedicaltechnologyinc | 2009-02-20 | Traditional | PDF ↗ |
| K080842 | APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] | Omni Life Science, Inc. | 2008-05-23 | Special | PDF ↗ |
| K080361 | REGENEREX TIBIAL COMPONENTS | Biomet, Inc. | 2008-04-21 | Traditional | PDF ↗ |
| K072575 | TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE | Stryker Orthopaedics | 2008-01-07 | Traditional | PDF ↗ |
| K073325 | LEGION POROUS PRIMARY | Smith & Nephew, Inc. | 2007-12-20 | Special | PDF ↗ |
| K072619 | NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS | Zimmer, Inc. | 2007-11-21 | Traditional | PDF ↗ |
| K072160 | NEXGEN TRABECULAR METAL TIBIAL TRAY | Zimmer, Inc. | 2007-09-05 | Special | PDF ↗ |
| K071790 | GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM | Smith & Nephew, Inc. | 2007-08-17 | Traditional | PDF ↗ |
| K071417 | DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES | DePuy Orthopaedics, Inc. | 2007-08-02 | Traditional | PDF ↗ |
| K071107 | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON | Zimmer, Inc. | 2007-07-06 | Traditional | PDF ↗ |
| K070883 | DURACON X3 CS TIBIAL INSERT | Howmedica Osteonics Corp. | 2007-05-11 | Traditional | PDF ↗ |
| K063128 | ADVANCE SPIKED POROUS TIBIAL BASE | Wrightmedicaltechnologyinc | 2007-03-21 | Traditional | PDF ↗ |
| K070214 | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM | Zimmer, Inc. | 2007-03-16 | Traditional | PDF ↗ |
| K063731 | ADVANCE STATURE FEMORAL COMPONENT | Wrightmedicaltechnologyinc | 2007-03-02 | Special | PDF ↗ |
| K062654 | DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS | DePuy Orthopaedics, Inc. | 2006-09-29 | Traditional | PDF ↗ |
| K061433 | VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE | Biomet Manufacturing, Inc. | 2006-08-21 | Traditional | PDF ↗ |
| K061223 | ADVANCE TOTAL KNEE SYSTEM | Wrightmedicaltechnologyinc | 2006-08-18 | Special | PDF ↗ |
| K053505 | REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS | Biomet Manufacturing, Inc. | 2006-08-14 | Traditional | PDF ↗ |
| K061521 | TRIATHLON METAL BACKED PATELLA | Howmedica Osteonics Corp. | 2006-08-11 | Special | PDF ↗ |
| K060303 | VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS | Biomet Manufacturing Corp | 2006-03-30 | Traditional | PDF ↗ |
| K051510 | SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM | Signal Medical Corp. | 2006-03-22 | Traditional | PDF ↗ |
| K053340 | TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS | Zimmer Trabecular | 2006-02-27 | Traditional | PDF ↗ |
| K051380 | TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM | Howmedica Osteonics Corp. | 2005-08-30 | Traditional | PDF ↗ |
| K050222 | VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS | Biomet, Inc. | 2005-08-16 | Special | PDF ↗ |
| K043083 | ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL | Wrightmedicaltechnologyinc | 2005-04-18 | Abbreviated | PDF ↗ |
| K043374 | DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING | Howmedica Osteonics Corp. | 2005-02-16 | Traditional | PDF ↗ |
| K040487 | TRABECULAR METAL KNEE SYSTEM AUGMENTS | Implex Corp. | 2004-12-21 | Traditional | PDF ↗ |
| K041100 | NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS | Zimmer, Inc. | 2004-10-29 | Special | PDF ↗ |
| K041872 | ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS | Biomet Manufacturing Corp | 2004-09-08 | Traditional | PDF ↗ |
| K032905 | 3DKNEE POROUS COATED FEMORAL COMPONENT | Encore Orthopedics, Inc. | 2004-07-06 | Traditional | PDF ↗ |
| K033489 | AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN | Biomet, Inc. | 2004-06-02 | Traditional | PDF ↗ |
| K033971 | SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING | Howmedica Osteonics Corp. | 2004-05-28 | Traditional | PDF ↗ |
| K033972 | SCORPIO TOTAL KNEE SYSTEM | Howmedica Osteonics Corp. | 2004-04-12 | Traditional | PDF ↗ |
| K032108 | SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) | Aesculap, Inc. | 2004-01-15 | Abbreviated | PDF ↗ |
| K032683 | GENESIS II POROUS PLUS HA KNEE SYSTEM | Smith & Nephew, Inc. | 2003-10-15 | Abbreviated | PDF ↗ |
| K031061 | NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS | Zimmer, Inc. | 2003-10-09 | Traditional | PDF ↗ |
| K032163 | DURACON TOTAL KNEE SYSTEM | Howmedica Osteonics Corp. | 2003-09-12 | Traditional | PDF ↗ |
| K032418 | DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING | Howmedica Osteonics Corp. | 2003-09-11 | Traditional | PDF ↗ |
| K031462 | THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS | Implex Corp. | 2003-08-06 | Traditional | PDF ↗ |
| K030612 | GENESIS II TOTAL KNEE SYSTEM | Smith & Nephew, Inc. | 2003-05-27 | Abbreviated | PDF ↗ |
| K030623 | SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM | Smith & Nephew, Inc. | 2003-05-22 | Abbreviated | PDF ↗ |
Product code MBH · Class II · Orthopedic. Data: openFDA.