DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT
FDA 510(k) clearance K953268 · decided 1996-01-17
Clearance details
- K-number
- K953268
- Device name
- DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT
- Applicant
- Stelkast Company
- Decision
- Substantially Equivalent
- Date received
- 1995-07-13
- Decision date
- 1996-01-17
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- LWJ
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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| EXCIA (K061699) | Aesculap, Inc. | 2006-08-18 |
| BETACONE HIP PROSTHESIS SYSTEM (K051826) | Waldemar Link GmbH & Co. KG | 2005-11-18 |
| U2 ACETABULAR COMPONENT (K050262) | United Orthopedic Corp. | 2005-08-15 |
| EXCIA TOTAL HIP SYSTEM (K042344) | Aesculap, Inc. | 2005-03-16 |
| Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED (K040685) | Osteoimplant Technology, Inc. | 2005-01-25 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use devic recall (Z-1073-2009) | Stelkast Co | 2009-03-31 |
| Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC143 recall (Z-0664-2009) | Stelkast Co | 2009-01-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| STELKAST SURPASS ACETABULAR SYSTEM (P040051/S002) | Stelkast Company | 2011-04-22 |
| STELKAST SURPASS ACETABULAR SYSTEM (P040051/S001) | Stelkast Company | 2009-05-08 |
| STELKAST SURPASS ACETABULAR SYSTEM (P040051) | Stelkast Company | 2006-05-12 |