C2 A-Taper Acetabular System

FDA premarket approval P050009 · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

PMA numberP050009

Approval

Applicant
Biomet, Inc.
Received
March 14, 2005
Decision date
December 16, 2005 (APWD)
Supplements
6, latest February 11, 2011
Product code
MRA – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Official FDA PMA record

Approval order statement

APPROVAL FOR THE C2A-TAPER ACETABULAR SYSTEM. THE DEVICE IS INDICATED FOR USE IN PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND POST-TRAUMATIC ARTHRITIS.