CORMET HIP RESURFACING SYSTEM

FDA premarket approval P050016/S002 · decided 2007-11-02

Approval details

PMA number

P050016

Supplement

S002

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

2007-09-04

Decision date

2007-11-02

Days to decision

59 days

Decision code

APPR

Product code

NXT

Advisory committee

Orthopedic

Expedited review

No

Location

Raynham, MA

Statement

APPROVAL FOR THE ADDITION OF INTERMEDIATE SIZES FOR BOTH THE FEMORAL HEAD (42MM, 46MM, 50MM, AND 54MM) AND THE CORRESPONDING ACETABULAR CUP COMPONENTS WITHIN THE PRODUCT LINE FOR THE CORMET HIP RESURFACING SYSTEM AND REVISIONS TO THE CORMET HIP RESURFACING LABELING TO REFLECT THESE ADDITIONAL INTERMEDIATE-SIZED COMPONENTS. THE DEVICE IS INDICATED FOR USE IN RESURFACING HIP ARTHROPLASTY FOR REDUCTION OR RELIEF OF PAIN AND/OR IMPROVED HIP FUNCTION IN SKELETALLY MATURE PATIENTS HAVING THE FOLLOWING

510(k) clearances by this applicant