Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA product code MBH · 129 cleared devices

Class 2 Orthopedic

Regulation: 21 CFR 888.3565
Review panel: OR
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2003-05-22 – 2026-09-17

MBH 2007-03-16

GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM

Applicant Zimmer, Inc.

K number K070214

View details →

MBH 2007-03-02

ADVANCE STATURE FEMORAL COMPONENT

Applicant Wrightmedicaltechnologyinc

K number K063731

View details →

MBH 2006-09-29

DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS

Applicant DePuy Orthopaedics, Inc.

K number K062654

View details →

MBH 2006-08-21

VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE

Applicant Biomet Manufacturing, Inc.

K number K061433

View details →

MBH 2006-08-18

ADVANCE TOTAL KNEE SYSTEM

Applicant Wrightmedicaltechnologyinc

K number K061223

View details →

MBH 2006-08-14

REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS

Applicant Biomet Manufacturing, Inc.

K number K053505

View details →

MBH 2006-08-11

TRIATHLON METAL BACKED PATELLA

Applicant Howmedica Osteonics Corp.

K number K061521

View details →

MBH 2006-03-30

VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS

Applicant Biomet Manufacturing Corp

K number K060303

View details →

MBH 2006-03-22

SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM

Applicant Signal Medical Corp.

K number K051510

View details →

MBH 2006-02-27

TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS

Applicant Zimmer Trabecular

K number K053340

View details →

MBH 2005-08-30

TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM

Applicant Howmedica Osteonics Corp.

K number K051380

View details →

MBH 2005-08-16

VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS

Applicant Biomet, Inc.

K number K050222

View details →

MBH 2005-04-18

ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL

Applicant Wrightmedicaltechnologyinc

K number K043083

View details →

MBH 2005-02-16

DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING

Applicant Howmedica Osteonics Corp.

K number K043374

View details →

MBH 2004-12-21

TRABECULAR METAL KNEE SYSTEM AUGMENTS

Applicant Implex Corp.

K number K040487

View details →

MBH 2004-10-29

NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS

Applicant Zimmer, Inc.

K number K041100

View details →

MBH 2004-09-08

ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS

Applicant Biomet Manufacturing Corp

K number K041872

View details →

MBH 2004-07-06

3DKNEE POROUS COATED FEMORAL COMPONENT

Applicant Encore Orthopedics, Inc.

K number K032905

View details →

MBH 2004-06-02

AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN

Applicant Biomet, Inc.

K number K033489

View details →

MBH 2004-05-28

SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING

Applicant Howmedica Osteonics Corp.

K number K033971

View details →

MBH 2004-04-12

SCORPIO TOTAL KNEE SYSTEM

Applicant Howmedica Osteonics Corp.

K number K033972

View details →

MBH 2004-01-15

SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)

Applicant Aesculap, Inc.

K number K032108

View details →

MBH 2003-10-15

GENESIS II POROUS PLUS HA KNEE SYSTEM

Applicant Smith & Nephew, Inc.

K number K032683

View details →

MBH 2003-10-09

NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS

Applicant Zimmer, Inc.

K number K031061

View details →

MBH 2003-09-12

DURACON TOTAL KNEE SYSTEM

Applicant Howmedica Osteonics Corp.

K number K032163

View details →

MBH 2003-09-11

DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING

Applicant Howmedica Osteonics Corp.

K number K032418

View details →

MBH 2003-08-06

THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS

Applicant Implex Corp.

K number K031462

View details →

MBH 2003-05-27

GENESIS II TOTAL KNEE SYSTEM

Applicant Smith & Nephew, Inc.

K number K030612

View details →

MBH 2003-05-22

SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM

Applicant Smith & Nephew, Inc.

K number K030623

View details →