Plasmafit Acetabular Cup and Vitelene Insert
FDA 510(k) K122783 · Aesculap Implant System, Inc.
Submission
- Device name
- Plasmafit Acetabular Cup and Vitelene Insert
- Applicant
- Aesculap Implant System, Inc.
Center Valley, PA, US - Received
- September 11, 2012
- Decision date
- October 30, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OQG – Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- 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 Plasmafit Acetabular Cup and Vitelene Insert cleared by the FDA?
Plasmafit Acetabular Cup and Vitelene Insert (K122783) received a 510(k) decision of Substantially Equivalent on October 30, 2013, 414 days after the submission was received.
What is the product code of K122783?
The FDA product code is OQG – Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.