Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OWW — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
122 daysmedian FDA review time
346 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Prot | Alafair Biosciences | 2025-07-18 | 49 | 0 |
| K250021 | Rotium | Nanofiber Solutions, LLC | 2025-02-27 | 55 | 0 |
| K242187 | BioBrace® | Conmed Corporation | 2024-11-27 | 125 | 0 |
| K241906 | BioBrace® Reinforced Implant | Conmed Corporation | 2024-07-29 | 28 | 0 |
| K240817 | VersaWrap | Alafair Biosciences, Inc. | 2024-06-14 | 81 | 0 |
| K222220 | SpinMedix Absorbable Fibrous Membrane | Celestray Biotech Company, LLC., | 2023-07-06 | 346 | 0 |
| K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | 2023-05-26 | 109 | 3 |
| K203267 | The BioBrace Implant | Biorez, Inc. | 2021-04-30 | 176 | 0 |
| K160364 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2016-06-10 | 122 | 0 |
| K121216 | STR GRAFT | Soft Tissue Regeneration, Inc. | 2012-11-21 | 212 | 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