Company ยท US
Stelkast Company
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2019. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 21 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 8 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 7 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 5 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 3 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 2 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 2 |
| JDO | Device, Fixation, Proximal Femoral, Implant | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 8, 2019 | K190276 | Provident II Hip Stem Stelkast, Inc. | LPH |
| Jan 19, 2018 | K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert Stelkast, Inc. | JWH |
| Sep 7, 2016 | K162222 | GENflex2 Total Knee System Stelkast, Inc. | JWH |
| Aug 5, 2013 | K122883 | EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM Stelkast Company | JWH |
| Oct 9, 2012 | K122773 | CROSS-OVER ACETABULAR SHELL & LINER Stelkast Company | OQG |
| Mar 24, 2011 | K094035 | EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM Stelkast Company | OQG |
| Jun 6, 2008 | K081458 | PROVEN STEM EXTENDER Stelkast Company | JWH |
| Jan 18, 2007 | K063211 | PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT Stelkast Company | JWH |
| Oct 17, 2005 | K051976 | PROVEN REVISION MODULAR TIBIAL TRAY Stelkast Company | JWH |
| Mar 12, 2004 | K033944 | STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD Stelkast Company | LZO |
| Nov 13, 2003 | K032824 | STELKAST UNICONDYLAR KNEE SYSTEM Stelkast Company | HSX |
| Oct 10, 2003 | K031901 | PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT Stelkast Company | JWH |
| Sep 22, 2003 | K032110 | PROCLASS PRESS FIT HIP STEM Stelkast Company | LWJ |
| Mar 25, 2003 | K030577 | PROVEN MODULAR TIBIAL TRAY Stelkast Company | JWH |
| Jul 9, 2002 | K021908 | PROVEN MODULAR POSTERIOR STABILIZED FEMORAL Stelkast Company | JWH |
| Jan 9, 2002 | K014049 | EPOCA CODR STEM AND HEAD Stelkast Company | KWT |
| Feb 9, 2001 | K010282 | LATERAL OFFSET PROTRACT PRESS FIT HIP STEM Stelkast Company | LPH |
| Feb 8, 2001 | K010241 | PROTRACT PRESS FIT HIP STEM-HA COATED Stelkast Company | LPH |
| Dec 15, 2000 | K003447 | PROTRACT PRESS FIT HIP STEM Stelkast Company | LPH |
| Sep 28, 2000 | K002796 | MODIFICATION TO PROVIDENT HIP SYSTEM Stelkast Company | LWJ |
| Sep 27, 2000 | K001984 | PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT Stelkast Company | JDG |
| Aug 17, 2000 | K002281 | STELKAST PROVEN KNEE SYSTEM Stelkast Company | JWH |
| Jul 27, 2000 | K001745 | MODIFICATION TO PROVIDENT HIP SYSTEM Stelkast Company | LWJ |
| Apr 4, 2000 | K000113 | PROVEN KNEE SYSTEM Stelkast Company | JWH |
| Jul 14, 1999 | K991622 | 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER Stelkast Company | JDI |
| Aug 21, 1998 | K981451 | ARGOMEDICAL BIPOLAR SYSTEM Stelkast Company | KWL |
| Apr 24, 1998 | K980276 | STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM Stelkast Company | JWH |
| Nov 4, 1997 | K972961 | STELKAST BIPOLAR SYSTEM Stelkast Company | JDI |
| May 2, 1997 | K970490 | PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT Stelkast Company | LZO |
| Apr 14, 1997 | K970194 | PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT Stelkast Company | JDI |
| Aug 8, 1996 | K960908 | SRRS PRESSED FIT FEMORAL REVISION COMPONENT Stelkast Company | LWJ |
| May 2, 1996 | K960180 | 22 MM COCR HEAD & POLYETHLENE LINER Stelkast Company | LPH |
| Jan 17, 1996 | K953268 | DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT Stelkast Company | LWJ |
| Dec 4, 1995 | K954466 | PROFORM POROUS BEADED FEMORAL STEM Stelkast Company | LPH |
| Aug 8, 1995 | K953169 | STELKAST ALL POLYETHYLENE ACETABULAR CUP Stelkast Company | LZO |
| Jun 30, 1995 | K952461 | ENDO PROSTHESIS FEMORAL HEAD Stelkast Company | JDI |
| May 22, 1995 | K951083 | PROFORM CEMENTED FEMORAL COMPONENT Stelkast Company | JDG |
| Apr 18, 1995 | K950827 | PROFORM POROUS ACETABULAR ASSEMBLY Stelkast Company | LPH |
| Apr 5, 1995 | K946371 | PROVIDENT HP SYSTEM Stelkast Company | JDI |
| Nov 14, 1994 | K936256 | MODULAR CERAMIC FEMORAL HEAD Stelkast Company | LZO |
| Jun 6, 1994 | K935484 | PROVIDENT HIP SYSTEM Stelkast Company | LPH |
| Mar 10, 1994 | K934161 | PROFORM HIP SYSTEM Stelkast Company | JDO |
| Mar 9, 1994 | K934162 | PROFORM HA HIP SYSTEM Stelkast Company | JDO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2015 | Stelkast Co EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post Terminated |
JWH | K122883 |
| Sep 3, 2013 | Stelkast Co SC2316, Distal Femoral Augment with Screw
Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous Terminated |
JWH | K021908 |
| Apr 7, 2013 | Stelkast Co Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52.
Intended for use in reconstruction of the articulating surface of the acetabula Terminated |
OQG | K122773 |
| Nov 20, 2009 | Stelkast Co Stelkast Unicondylar Knee Femoral Component SC2462-1.
Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee impl Terminated |
HSX | K032824 |
| Mar 31, 2009 | Stelkast Co Dual Taper Wedge Pressed Fit Femoral Component.
The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip Terminated |
LWJ | K953268 |
| Jan 28, 2009 | Stelkast Co Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439 Terminated |
LWJ | K953268 |
| Nov 25, 2008 | Stelkast Co Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm.
The Proven Knee System is a single use device intended for cemented reconstruction of the f Terminated |
JWH | K980276 |
| Jan 23, 2008 | Stelkast Co StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number: SC2287-5-5, Size 5, Thickness 5 mm, StelKast, Murray, PA 15317 Terminated |
JWH | K051976 |
| Jan 23, 2008 | Stelkast Co StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-4-5, Size 4, Thickness 5 mm, StelKast, Murray, PA 15317 Terminated |
JWH | K051976 |
| Jan 23, 2008 | Stelkast Co StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-3-5, Size 3, Thickness 5 mm, StelKast, Murray, PA 15317 Terminated |
JWH | K051976 |
| Jan 23, 2008 | Stelkast Co StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-2-5, Size 2 Thickness 5 mm, StelKast, Murray, PA 15317 Terminated |
JWH | K051976 |
| Jan 23, 2008 | Stelkast Co StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm, StelKast, Murray, PA 15317 Terminated |
JWH | K051976 |
| Feb 3, 2005 | Stelkast Co Proven Porous CR Femur. Implantable orthopedic device Terminated |
JWH | K002281 |