Panels › Orthopedic › Product code MBH · Class 2
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation 888.3565
9510(k)s in 12 months (146 all time)
4recalls in 12 months (103 all time)
103recalls that name a 510(k)
Top companies in MBH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 25, 2010 | K093405 | PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES Wrightmedicaltechnologyinc | MBH |
| May 13, 2010 | K100897 | LEGION POROUS + HA TIBIAL BASEPLATES Smith & Nephew, Inc. | MBH |
| Feb 17, 2010 | K093533 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 Materialise NV, BE | MBH |
| Dec 21, 2009 | K091543 | LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS Smith & Nephew, Inc. | MBH |
| Apr 3, 2009 | K083782 | REGENEREX PATELLA COMPONENTS Biomet Manufacturing Corp | MBH |
| Feb 20, 2009 | K081479 | ADVANCE A-CLASS TIBIAL INSERT Wrightmedicaltechnologyinc | MBH |
| May 23, 2008 | K080842 | APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] Omni Life Science, Inc. | MBH |
| Apr 21, 2008 | K080361 | REGENEREX TIBIAL COMPONENTS Biomet, Inc. | MBH |
| Jan 7, 2008 | K072575 | TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE Stryker Orthopaedics | MBH |
| Dec 20, 2007 | K073325 | LEGION POROUS PRIMARY Smith & Nephew, Inc. | MBH |
| Nov 21, 2007 | K072619 | NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS Zimmer, Inc. | MBH |
| Sep 5, 2007 | K072160 | NEXGEN TRABECULAR METAL TIBIAL TRAY Zimmer, Inc. | MBH |
| Aug 17, 2007 | K071790 | GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM Smith & Nephew, Inc. | MBH |
| Aug 2, 2007 | K071417 | DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES DePuy Orthopaedics, Inc. | MBH |
| Jul 6, 2007 | K071107 | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM; NEX GEN COMPLETE KNEE SOLUTION CR-FLEX GENDER SOLUTIONS FEMALE FEMORAL COMPON Zimmer, Inc. | MBH |
| May 11, 2007 | K070883 | DURACON X3 CS TIBIAL INSERT Howmedica Osteonics Corp. | MBH |
| Mar 21, 2007 | K063128 | ADVANCE SPIKED POROUS TIBIAL BASE Wrightmedicaltechnologyinc | MBH |
| Mar 16, 2007 | K070214 | GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM Zimmer, Inc. | MBH |
| Mar 2, 2007 | K063731 | ADVANCE STATURE FEMORAL COMPONENT Wrightmedicaltechnologyinc | MBH |
| Sep 29, 2006 | K062654 | DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS DePuy Orthopaedics, Inc. | MBH |
| Aug 21, 2006 | K061433 | VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE Biomet Manufacturing, Inc. | MBH |
| Aug 18, 2006 | K061223 | ADVANCE TOTAL KNEE SYSTEM Wrightmedicaltechnologyinc | MBH |
| Aug 14, 2006 | K053505 | REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS Biomet Manufacturing, Inc. | MBH |
| Aug 11, 2006 | K061521 | TRIATHLON METAL BACKED PATELLA Howmedica Osteonics Corp. | MBH |
| Mar 30, 2006 | K060303 | VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS Biomet Manufacturing Corp | MBH |
| Mar 22, 2006 | K051510 | SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM Signal Medical Corp. | MBH |
| Feb 27, 2006 | K053340 | TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS Zimmer Trabecular | MBH |
| Aug 30, 2005 | K051380 | TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM Howmedica Osteonics Corp. | MBH |
| Aug 16, 2005 | K050222 | VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS Biomet, Inc. | MBH |
| Apr 18, 2005 | K043083 | ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL Wrightmedicaltechnologyinc | MBH |
| Feb 16, 2005 | K043374 | DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING Howmedica Osteonics Corp. | MBH |
| Dec 21, 2004 | K040487 | TRABECULAR METAL KNEE SYSTEM AUGMENTS Implex Corp. | MBH |
| Oct 29, 2004 | K041100 | NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS Zimmer, Inc. | MBH |
| Sep 8, 2004 | K041872 | ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS Biomet Manufacturing Corp | MBH |
| Jul 6, 2004 | K032905 | 3DKNEE POROUS COATED FEMORAL COMPONENT Encore Orthopedics, Inc. | MBH |
| Jun 2, 2004 | K033489 | AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN Biomet, Inc. | MBH |
| May 28, 2004 | K033971 | SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING Howmedica Osteonics Corp. | MBH |
| Apr 12, 2004 | K033972 | SCORPIO TOTAL KNEE SYSTEM Howmedica Osteonics Corp. | MBH |
| Jan 15, 2004 | K032108 | SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) Aesculap, Inc. | MBH |
| Oct 15, 2003 | K032683 | GENESIS II POROUS PLUS HA KNEE SYSTEM Smith & Nephew, Inc. | MBH |
| Oct 9, 2003 | K031061 | NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS Zimmer, Inc. | MBH |
| Sep 12, 2003 | K032163 | DURACON TOTAL KNEE SYSTEM Howmedica Osteonics Corp. | MBH |
| Sep 11, 2003 | K032418 | DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING Howmedica Osteonics Corp. | MBH |
| Aug 6, 2003 | K031462 | THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS Implex Corp. | MBH |
| May 27, 2003 | K030612 | GENESIS II TOTAL KNEE SYSTEM Smith & Nephew, Inc. | MBH |
| May 22, 2003 | K030623 | SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM Smith & Nephew, Inc. | MBH |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.