Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Instratek, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
332 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133523 | STAPIX SUPERELASTIC IMPLANT BONE STAPLES | Instratek, Inc. | 2014-02-06 | 83 | 0 |
| K131620 | JONES-FX FRACTURE SYSTEM | Instratek, Inc. | 2013-07-25 | 52 | 0 |
| K120493 | MINI CANNULATED HEADED AND HEADLESS SCREW SET | Instratek, Inc. | 2012-05-17 | 90 | 1 |
| K111032 | CMC CABLE FIX | Instratek, Inc. | 2011-08-31 | 140 | 0 |
| K091763 | MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 | Instratek, Inc. | 2009-08-14 | 59 | 0 |
| K082384 | HAV-LOK BUNION CORRECTION SYSTEM | Instratek, Inc. | 2008-12-08 | 111 | 0 |
| K080280 | SUB-TALAR LOK, MODEL 7-11 MM | Instratek, Inc. | 2008-03-14 | 39 | 0 |
| K940230 | ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS | Instratek, Inc. | 1994-12-12 | 332 | 0 |
| K925083 | ENDOTRAK SYSTEM | Instratek, Inc. | 1993-04-27 | 202 | 0 |
| K922391 | ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS | Instratek, Inc. | 1992-08-18 | 90 | 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