Stelkast Company: FDA filings under this applicant name
FDA lists 43 510(k) clearances under 2 spellings of the applicant name “Stelkast Company” (first 1994, latest 2019), plus 1 PMA decision, across 12 product codes in 1 review panel. Median 510(k) review time under this name: 75 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 29 |
| 2013 | 1 | 319 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 30 |
| 2017 | 0 | — |
| 2018 | 1 | 29 |
| 2019 | 1 | 28 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Stelkast Company took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 12 | 12 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 8 | 8 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 5 | 5 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 5 | 5 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 | 4 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 2 | 2 |
| JDO | Device, Fixation, Proximal Femoral, Implant | 2 | 2 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 2 | 2 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 | 1 |
Plus 2 more product codes.
Review panels
- Orthopedic (44)
Most recent Stelkast Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K190276 | Provident II Hip Stem | LPH | 2019-03-08 | 28 |
| K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert | JWH | 2018-01-19 | 29 |
| K162222 | GENflex2 Total Knee System | JWH | 2016-09-07 | 30 |
| K122883 | EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM | JWH | 2013-08-05 | 319 |
| K122773 | CROSS-OVER ACETABULAR SHELL & LINER | OQG | 2012-10-09 | 29 |
| K094035 | EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM | OQG | 2011-03-24 | 449 |
| K081458 | PROVEN STEM EXTENDER | JWH | 2008-06-06 | 14 |
| K063211 | PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT | JWH | 2007-01-18 | 87 |
| K051976 | PROVEN REVISION MODULAR TIBIAL TRAY | JWH | 2005-10-17 | 88 |
| K033944 | STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD | LZO | 2004-03-12 | 84 |
33 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P040051 | PMA | STELKAST SURPASS ACETABULAR SYSTEM | 2006-05-12 |
Recalls
13 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2014-12-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Stelkast Company (41)
- Stelkast, Inc. (3)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stelkast Company?
FDA lists 43 510(k) clearances under 2 spellings of the applicant name “Stelkast Company” (first 1994, latest 2019), plus 1 PMA decision, across 12 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Stelkast Company?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stelkast Company is 75 days.
Which FDA product codes appear under Stelkast Company?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 12); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 8); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 5).
Next steps
- See all 43 Stelkast Company clearances with predicates and recalls
- Run predicate analysis for product code JWH, Stelkast Company's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.