Cleared Special

Klassic HD? Hooded Acetabular Insert with E-Link? Poly, Klassic HD? Low Profile Acetabular Insert with E-Link? Poly

K173104 · Total Joint Orthopedics, Inc. · Orthopedic

Oct 2017

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K173104 is an FDA 510(k) clearance for the Klassic HD? Hooded Acetabular Insert with E-Link? Poly, Klassic HD? Low Profile Acetabular Insert with E-Link? Poly, a Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented (Class II — Special Controls, product code OQG), submitted by Total Joint Orthopedics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 27, 2017, 28 days after receiving the submission on September 29, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K173104 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2017
Decision Date	October 27, 2017
Days to Decision	28 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.