Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PLF — Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
294 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252733 | ATLAS™ Expandable Osteotomy Wedge System | MiRus, LLC | 2026-02-19 | 175 | 0 |
| K252254 | Osteotomy Wedge System | Sinaptic Surgical | 2025-10-17 | 88 | 0 |
| K251791 | Auxano® Wedge Fixation System | Auxano Medical, LLC | 2025-09-25 | 106 | 0 |
| K240461 | OsteoSinter® EVANS and COTTON wedges and related accessories | Ames Medical Prosthetic Solutions, S.A.U. | 2024-12-06 | 294 | 0 |
| K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024-11-08 | 30 | 0 |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies | 2024-01-26 | 30 | 0 |
| K231496 | TITAN 3-D Wedge System | Paragon 28, Inc. | 2023-08-22 | 90 | 0 |
| K223226 | Trigon™ HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022-12-01 | 44 | 0 |
| K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022-02-23 | 30 | 0 |
| K201314 | Restor3d Utility Wedge | Restor3D, Inc. | 2021-06-17 | 395 | 0 |
| K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020-12-21 | 28 | 0 |
| K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020-02-25 | 78 | 0 |
| K192645 | Trigon™ Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2019-12-23 | 90 | 0 |
| K191047 | ADI TiDAL Osteotomy Wedge | Additive Device, Inc. (Adi) D/B/A Restor3D | 2019-11-05 | 200 | 0 |
| K171327 | Tyber Medical Wedge System | Tyber Medical, LLC | 2017-05-16 | 11 | 0 |
| K162241 | TITAN 3-D™ Wedge System | Paragon 28 | 2017-04-03 | 236 | 1 |
| K151256 | Arthrex BioSync® Bone Wedge | Arthex, Inc. | 2015-08-12 | 92 | 0 |
| K150394 | Tyber Medical Wedge System | Tyber Medical, LLC | 2015-07-28 | 160 | 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