CORMET HIP RESURFACING SYSTEM

FDA premarket approval P050016/S007 · decided 2011-01-13

Approval details

PMA number

P050016

Supplement

S007

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

CORMET HIP RESURFACING SYSTEM

Generic name

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

Applicant

Corin USA

Date received

2010-11-19

Decision date

2011-01-13

Days to decision

55 days

Decision code

APPR

Product code

NXT

Advisory committee

Orthopedic

Expedited review

No

Location

Raynham, MA

Statement

APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE CORMET HIP RESURFACING SYSTEM WHICH 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 ARTHRITIS SUCH AS OSTEOARTHRITIS AND AVASCULAR NECROSIS; AND 2) INFLAMMATORY

510(k) clearances by this applicant