Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stelkast, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190276 | Provident II Hip Stem | Stelkast, Inc. | 2019-03-08 | 28 | 0 |
| K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Inser | Stelkast, Inc. | 2018-01-19 | 29 | 0 |
| K162222 | GENflex2 Total Knee System | Stelkast, Inc. | 2016-09-07 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda