Cleared Special

CROSS-OVER ACETABULAR SHELL & LINER

K122773 · Stelkast Company · Orthopedic

Oct 2012

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K122773 is an FDA 510(k) clearance for the CROSS-OVER ACETABULAR SHELL & LINER, a Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented (Class II — Special Controls, product code OQG), submitted by Stelkast Company (Mcmurray, US). The FDA issued a Cleared decision on October 9, 2012, 29 days after receiving the submission on September 10, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K122773 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2012
Decision Date	October 09, 2012
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OQG — Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358
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.