# Stelkast Company

- Location (FDA's records): Pittsburgh, PA
- FDA decisions: 44 (1994–2019): 43 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Stelkast Company (41); Stelkast, Inc. (3)
- Product codes: JWH (12), LPH (8), JDI (5), LWJ (5), LZO (4), OQG (2), JDO (2), JDG (2), HSX (1), KWT (1), KWL (1), MRA (1)
- 510(k) review time since 2016: median 29 days, against 90 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 24 (21 its own); citations of its devices by later devices: 61 (21 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)
- Biomet Manufacturing Corp: 1 (https://510kreport.com/company/biomet-manufacturing)

## Firms that cite its devices most
- Globus Medical, Inc.: 16 (https://510kreport.com/company/globus-medical)
- Accelerated Innovation, LLC: 9 (https://510kreport.com/company/accelerated-innovation)
- Renovis Surgical Technologies, LLC: 2 (https://510kreport.com/company/renovis-surgical-technologies)
- Novosource, Inc.: 2 (https://510kreport.com/company/novosource)
- Consensus Orthopedics, Inc.: 2 (https://510kreport.com/company/consensus-orthopedics)
- Cardo Medical Corp.: 1 (https://510kreport.com/company/cardo-medical)
- Arthrosurface, Inc.: 1 (https://510kreport.com/company/arthrosurface)
- Pipeline Orthopedics: 1 (https://510kreport.com/company/pipeline-orthopedics)

## Its most-cited devices
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM (2011), cited by 10
- K980276: Stelkast Proven Cemented, Semi-Constrained Total Knee System (1998), cited by 5
- K935484: Provident Hip System (1994), cited by 5
- K063211: Proven Knee System High Flexion Tibial Insert (2007), cited by 4
- K122883: Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System (2013), cited by 4
- K950827: Proform Porous Acetabular Assembly (1995), cited by 3

## Recent decisions
- K190276: Provident II Hip Stem (Mar 8, 2019)
- K173875: GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert (Jan 19, 2018)
- K162222: GENflex2 Total Knee System (Sep 7, 2016)
- K122883: Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System (Aug 5, 2013)
- K122773: Cross-Over Acetabular Shell & Liner (Oct 9, 2012)
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM (Mar 24, 2011)
- K081458: Proven Stem Extender (Jun 6, 2008)
- K063211: Proven Knee System High Flexion Tibial Insert (Jan 18, 2007)

Source page: https://510kreport.com/company/stelkast