Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Restor3D, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
228 daysmedian FDA review time
728 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252067 | Velora Acetabular System | Restor3D, Inc. | 2025-12-05 | 157 | 0 |
| K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replace | Restor3D, Inc. | 2025-03-27 | 111 | 0 |
| K242356 | TIDAL Fusion Cage System | Restor3D, Inc. | 2025-03-24 | 228 | 0 |
| K240591 | restor3d Kinos Axiom Total Ankle System | Restor3D, Inc. | 2024-04-29 | 59 | 0 |
| K201393 | restor3d MTP Implant | Restor3D, Inc. | 2022-05-25 | 728 | 0 |
| K201314 | Restor3d Utility Wedge | Restor3D, Inc. | 2021-06-17 | 395 | 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