Cleared Traditional

E-XPE Acetabular Components and U-Motion II Acetabular Cup

K172833 · United Orthopedic Corporation · Orthopedic
Jun 2018
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K172833 is an FDA 510(k) clearance for the E-XPE Acetabular Components and U-Motion II Acetabular Cup, a Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented (Class II — Special Controls, product code OQI), submitted by United Orthopedic Corporation (Hsinchu, TW). The FDA issued a Cleared decision on June 12, 2018, 266 days after receiving the submission on September 19, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number K172833 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2017
Decision Date June 12, 2018
Days to Decision 266 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.