Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OWX — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
202 daysmedian FDA review time
267 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253867 | FiberLocker Implant ; FiberLocker Instrument ; FiberLocker P | ZuriMED Technologies AG | 2026-01-02 | 30 | 0 |
| K250997 | Integrity™ Implant | Anika Therapeutics, Inc. | 2025-06-17 | 77 | 0 |
| K243480 | SuturePatch Tissue Reinforcement | Arthrex, Inc. | 2025-05-29 | 202 | 0 |
| K241219 | FiberLocker System: FiberLocker Implant (SpeedPatch PET), Fi | ZuriMED Technologies AG | 2024-12-11 | 224 | 0 |
| K223538 | Integrity Implant | Anika Therapeutics, Inc. | 2023-08-17 | 267 | 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