PMA P910016S008

Device: NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
Applicant: Depuy, Inc.
PMA number: P910016
Supplement: S008
Product code: MBD
Decision date: 1997-01-29
Generic name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Approval order statement: APPROVAL FOR SIX SIZE OPTIONS, TWO FIXATION PEGS ON THE FEMORAL COMPONENT, A 7 DEGREE DISTAL BONE CUT SURFACE ON THE FEMORAL COMPONENT, AND A SINGLE MENISCAL BEARING TRACK ACROSS ALL SIZES OF THE TIBIAL COMPONENT FOR THE SECOND GENERATION OF TH E NEW JERSEY LCS TOTAL KNEE SYSTEM UNICOMPARTMENTAL DEVICE CONFIGURATION.

Current openFDA PMA Record

Device: NEW JERSEY LCS(R) UNICOMPARTMENTAL KNEE
Applicant: Depuy, Inc.
PMA number: P910016
Supplement: S008
Product code: MBD
Generic name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Decision date: 1997-01-29
Decision code: APPR
Date received: 1996-12-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR SIX SIZE OPTIONS, TWO FIXATION PEGS ON THE FEMORAL COMPONENT, A 7 DEGREE DISTAL BONE CUT SURFACE ON THE FEMORAL COMPONENT, AND A SINGLE MENISCAL BEARING TRACK ACROSS ALL SIZES OF THE TIBIAL COMPONENT FOR THE SECOND GENERATION OF TH E NEW JERSEY LCS TOTAL KNEE SYSTEM UNICOMPARTMENTAL DEVICE CONFIGURATION.