Cross-Over Acetabular Shell & Liner
FDA 510(k) K122773 · Stelkast Company
Submission
- Device name
- Cross-Over Acetabular Shell & Liner
- Applicant
- Stelkast Company
Mcmurray, PA, US - Received
- September 10, 2012
- Decision date
- October 9, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K162222 | GENflex2 Total Knee SystemJWH · Special | 09/07/2016SE |
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| K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMOQG · Traditional | 03/24/2011SE |
| K081458 | Proven Stem ExtenderJWH · Special | 06/06/2008SE |
| K063211 | Proven Knee System High Flexion Tibial InsertJWH · Traditional | 01/18/2007SE |
| K051976 | Proven Revision Modular Tibial TrayJWH · Traditional | 10/17/2005SE |
| K033944 | Stelkast 32MM Modular Ceramic Femoral HeadLZO · Traditional | 03/12/2004SE |
| K032824 | Stelkast Unicondylar Knee SystemHSX · Traditional | 11/13/2003SE |
Questions and answers
When was Cross-Over Acetabular Shell & Liner cleared by the FDA?
Cross-Over Acetabular Shell & Liner (K122773) received a 510(k) decision of Substantially Equivalent on October 9, 2012, 29 days after the submission was received.
What is the product code of K122773?
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.