Cleared Traditional

CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS

K111481 · Corin USA · Orthopedic

Feb 2012

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K111481 is an FDA 510(k) clearance for the CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS, a Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented (Class II — Special Controls, product code OQI), submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on February 6, 2012, 255 days after receiving the submission on May 27, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K111481 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2011
Decision Date	February 06, 2012
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OQI — Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353
Definition	1. Non-inflammatory Degenerative Joint Disease Including Osteoarthritis And Avascular Necrosis. 2. Rheumatoid Arthritis. 3. Correction Of Functional Deformity. 4. Treatment Of Non-union, Femoral Neck Fracture, And Trochanteric Fractures Of The Proximal Femur With Head Involvement, Unmanageable By Other Techniques. 5. Revision Procedures Where Other Treatment Or Devices Have Failed. Cemented And Uncemented Use.