STELKAST SURPASS ACETABULAR SYSTEM
FDA premarket approval P040051/S001 · decided 2009-05-08
Approval details
- PMA number
- P040051
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STELKAST SURPASS ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Stelkast Company
- Date received
- 2007-12-17
- Decision date
- 2009-05-08
- Days to decision
- 508 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mcmurray, PA
- Statement
- APPROVAL FOR IMPLEMENTATION OF NEW SOFTWARE TO THE MANUFACTURING LINE TO ALLOW POLISHED INSERTS TO BE REWORKED, FOLLOWING INSPECTION, IN ONE OF THE TWO INNER SPHERE POLISHING STATIONS, WHILE THE OTHER STATION CONTINUES TO BE USED FOR INITIAL PRODUCTION.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM (K122883) | Stelkast Company | 2013-08-05 |
| CROSS-OVER ACETABULAR SHELL & LINER (K122773) | Stelkast Company | 2012-10-09 |
| EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM (K094035) | Stelkast Company | 2011-03-24 |
| PROVEN STEM EXTENDER (K081458) | Stelkast Company | 2008-06-06 |
| PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT (K063211) | Stelkast Company | 2007-01-18 |
| PROVEN REVISION MODULAR TIBIAL TRAY (K051976) | Stelkast Company | 2005-10-17 |
| STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD (K033944) | Stelkast Company | 2004-03-12 |
| STELKAST UNICONDYLAR KNEE SYSTEM (K032824) | Stelkast Company | 2003-11-13 |