CORMET HIP RESURFACING SYSTEM

FDA premarket approval P050016/S003 · decided 2008-07-07

Approval details

PMA number

P050016

Supplement

S003

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CORMET HIP RESURFACING SYSTEM

Generic name

Prosthesis, hip, semi-constrained, metal/metal, resurfacing

Applicant

Corin USA

Date received

2008-05-16

Decision date

2008-07-07

Days to decision

52 days

Decision code

APPR

Product code

NXT

Advisory committee

Orthopedic

Expedited review

No

Location

Raynham, MA

Statement

APPROVAL FOR A NEW HEAD FINISHING REAMER, THE ADDITION OF A STRAIGHT HANDLED MECHANICAL CUP INTRODUCER AND A REVISED CORMET OPERATIVE TECHNIQUE. THE DEVICE IS INDICATED FOR HYBRID FIXATION: CEMENTED FEMORAL HEAD AND CEMENTLESS ACETABULAR COMPONENT. THE CORMET HIP RESURFACING SYSTEM IS INTENDED FOR USE IN RESURFACING HIP ARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATURE PATIENTS HAVING THE FOLLOWING CONDITIONS: 1) NON-INFLAMMATORY DEGENERATIVE ARTHRITI

510(k) clearances by this applicant