Stelkast Company
Medical device manufacturer in Mcmurray, PA.
43510(k) clearances
1PMA approvals
12recalls
Device types
- JWH Prosthesis, Knee, Patellofemorotibial… 12
- LPH Prosthesis, Hip, Semi-Constrained… 8
- JDI Prosthesis, Hip, Semi-Constrained… 5
- LWJ Prosthesis, Hip, Semi-Constrained… 5
- LZO Prosthesis, Hip, Semi-Constrained… 4
- JDO Device, Fixation, Proximal Femoral, Implant 2
- JDG Prosthesis, Hip, Femoral Component… 2
- OQG Hip Prosthesis, Semi-Constrained, Cemented… 2
- KWL Prosthesis, Hip, Hemi-, Femoral, Metal 1
- KWT Prosthesis, Shoulder, Non-Constrained… 1
- HSX Prosthesis, Knee, Femorotibial… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K190276 | Provident II Hip StemLPH · Special | 03/08/2019SE |
| K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertJWH · Special | 01/19/2018SE |
| K162222 | GENflex2 Total Knee SystemJWH · Special | 09/07/2016SE |
| K122883 | Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemJWH · Traditional | 08/05/2013SE |
| K122773 | Cross-Over Acetabular Shell & LinerOQG · Special | 10/09/2012SE |
| 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 |
| K031901 | Proven Revision Femoral and Proven Revision Tibial InsertJWH · Special | 10/10/2003SE |
| K032110 | Proclass Press Fit Hip StemLWJ · Traditional | 09/22/2003SE |
| K030577 | Proven Modular Tibial TrayJWH · Special | 03/25/2003SE |
| K021908 | Proven Modular Posterior Stabilized FemoralJWH · Special | 07/09/2002SE |
| K014049 | Epoca Codr Stem and HeadKWT · Special | 01/09/2002SE |
| K010282 | Lateral Offset Protract Press Fit Hip StemLPH · Special | 02/09/2001SE |
| K010241 | Protract Press Fit Hip Stem-Ha CoatedLPH · Special | 02/08/2001SE |
| K003447 | Protract Press Fit Hip StemLPH · Traditional | 12/15/2000SE |
| K002796 | Modification to Provident Hip SystemLWJ · Special | 09/28/2000SE |
| K001984 | Progeny Forged Cocr Cemented Femoral ComponentJDG · Traditional | 09/27/2000SE |
| K002281 | Stelkast Proven Knee SystemJWH · Special | 08/17/2000SE |
| K001745 | Modification to Provident Hip SystemLWJ · Special | 07/27/2000SE |
| K000113 | Proven Knee SystemJWH · Traditional | 04/04/2000SE |
| K991622 | 26 MM Cast Cocr Head and Polyethylene Acetabular Shell LinerJDI · Traditional | 07/14/1999SE |
| K981451 | Argomedical Bipolar SystemKWL · Traditional | 08/21/1998SE |
| K980276 | Stelkast Proven Cemented, Semi-Constrained Total Knee SystemJWH · Traditional | 04/24/1998SE |
| K972961 | Stelkast Bipolar SystemJDI · Traditional | 11/04/1997SE |
| K970490 | Proform General Application Cemented Femoral ComponentLZO · Traditional | 05/02/1997SE |
| K970194 | Proform Cemented Titanium Revision Femoral ComponentJDI · Traditional | 04/14/1997SE |
| K960908 | SRRS Pressed Fit Femoral Revision ComponentLWJ · Traditional | 08/08/1996SE |
| K960180 | 22 MM Cocr Head & Polyethlene LinerLPH · Traditional | 05/02/1996SE |
| K953268 | Dual Taper Wedge Pressed Fit Femoral ComponentLWJ · Traditional | 01/17/1996SE |
| K954466 | Proform Porous Beaded Femoral StemLPH · Traditional | 12/04/1995SE |
| K953169 | Stelkast All Polyethylene Acetabular CupLZO · Traditional | 08/08/1995SE |
| K952461 | Endo Prosthesis Femoral HeadJDI · Traditional | 06/30/1995SE |
| K951083 | Proform Cemented Femoral ComponentJDG · Traditional | 05/22/1995SN |
| K950827 | Proform Porous Acetabular AssemblyLPH · Traditional | 04/18/1995SE |
| K946371 | Provident HP SystemJDI · Traditional | 04/05/1995SE |
| K936256 | Modular Ceramic Femoral HeadLZO · Traditional | 11/14/1994SE |
| K935484 | Provident Hip SystemLPH · Traditional | 06/06/1994SN |
| K934161 | Proform Hip SystemJDO · Traditional | 03/10/1994SE |
| K934162 | Proform Ha Hip SystemJDO · Traditional | 03/09/1994SN |
PMA approvals
- P040051 Stelkast Surpass Acetabular System · 05/12/2006 · 2 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0970-2015 Class II | EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is…Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in… | 12/01/2014Terminated |
| Z-2136-2013 Class II | SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis…The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of… | 06/24/2013Terminated |
| Z-1066-2013 Class II | Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52…Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over… | 01/24/2013Terminated |
| Z-0371-2010 | Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment…incorrect size markings on component | 05/05/2009Terminated |
| Z-1073-2009 | Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use…A possible breach of the sterile barrier packaging (Tyvek pouch). | 10/31/2008Terminated |
| Z-0664-2009 | Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number…Sterility may be compromised due to breach in packaging. | 10/07/2008Terminated |
| Z-0308-2009 | Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the…Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot… | 09/03/2008Terminated |
| Z-0483-2008 | StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number:…The screws may fracture | 10/05/2007Terminated |
| Z-0482-2008 | StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-4-5…The screws may fracture | 10/05/2007Terminated |
| Z-0481-2008 | StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-3-5…The screws may fracture | 10/05/2007Terminated |
| Z-0480-2008 | StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-2-5…The screws may fracture | 10/05/2007Terminated |
| Z-0479-2008 | StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number…The screws may fracture | 10/05/2007Terminated |