510(k) Report

FDA applicant

Stelkast Company

Pittsburgh, PA44 decisions1994–201913 recalls

FDA records 44 decisions for Stelkast Company (Pittsburgh, PA) from 1994 to 2019: 43 510(k) clearances and 1 original PMA approval. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and LPH (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 21 of them its own earlier devices. 13 recalls are linked to its devices.

FDA’s records also spell it “Stelkast, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Stelkast Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2007: 12008: 12011: 12012: 12013: 12016: 12018: 12019: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2014

2007: 52008: 32009: 12013: 22014: 1
2007high 5 (2007) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Stelkast Company by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer12decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented8decisions
  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented5decisions
  • LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented5decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…4decisions
  • OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented2decisions

Also: JDO (2), JDG (2), HSX (1), KWT (1), KWL (1), MRA (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 29 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 24 predicates; 21 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 61 times; 21 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company · 201110cite it
  • K980276Stelkast Proven Cemented, Semi-Constrained Total Knee SystemStelkast Company · 19985cite it
  • K935484Provident Hip SystemStelkast Company · 19945cite it
  • K063211Proven Knee System High Flexion Tibial InsertStelkast Company · 20074cite it
  • K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company · 20134cite it
  • K950827Proform Porous Acetabular AssemblyStelkast Company · 19953cite it

What has FDA decided for it lately?

  • K190276Provident II Hip StemStelkast, Inc. · 2019
  • K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc. · 2018
  • K162222GENflex2 Total Knee SystemStelkast, Inc. · 2016
  • K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company · 20131 recall
  • K122773Cross-Over Acetabular Shell & LinerStelkast Company · 20121 recall
  • K094035Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMStelkast Company · 2011
  • K081458Proven Stem ExtenderStelkast Company · 2008
  • K063211Proven Knee System High Flexion Tibial InsertStelkast Company · 2007

All 41 as Stelkast Company →All 3 as Stelkast, Inc. →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K122883EXp Tibial Insert ; Intended Use of Device (s): The Proven Gen-Flex Total Knee System is…Dec 1, 2014Class II
  • K021908SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis…Jun 24, 2013Class II
  • K122773Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52…Jan 24, 2013Class II
  • K032824Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment…May 5, 2009
  • K953268Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use…Oct 31, 2008
  • K953268Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number…Oct 7, 2008