Stelkast Surpass Acetabular System

FDA premarket approval P040051 · Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

PMA numberP040051

Approval

Applicant
Stelkast Company
Received
December 27, 2004
Decision date
May 12, 2006 (APWD)
Supplements
2, latest April 22, 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 STELKAST SURPASS ACETABULAR SYSTEM. THE DEVICE IS INDICATED FOR CEMENTLESS USE IN PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE INDIVIDUALS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND TRAUMATIC ARTHRITIS.