E-XPE Acetabular Components and U-Motion II Acetabular Cup
FDA 510(k) K172833 · United Orthopedic Corporation
Submission
- Device name
- E-XPE Acetabular Components and U-Motion II Acetabular Cup
- Applicant
- United Orthopedic Corporation
Hsinchu, TW - Received
- September 19, 2017
- Decision date
- June 12, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OQI – Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
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…
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Questions and answers
When was E-XPE Acetabular Components and U-Motion II Acetabular Cup cleared by the FDA?
E-XPE Acetabular Components and U-Motion II Acetabular Cup (K172833) received a 510(k) decision of Substantially Equivalent on June 12, 2018, 266 days after the submission was received.
What is the product code of K172833?
The FDA product code is OQI – Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.