Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Rti Surgical, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
266 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253145 | Pre-Sutured Tendon | Rti Surgical, Inc. | 2025-10-22 | 27 | 0 |
| K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CC | Rti Surgical, Inc. | 2025-02-21 | 266 | 0 |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Ten | Rti Surgical, Inc. | 2023-06-23 | 178 | 0 |
| K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D | Rti Surgical, Inc. | 2017-10-23 | 82 | 0 |
| K163673 | Fortilink™-C with TETRAfuse™ 3D Technology | Rti Surgical, Inc. | 2017-05-23 | 147 | 0 |
| K142070 | FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS | Rti Surgical, Inc. | 2014-10-27 | 89 | 0 |
| K132850 | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT | Rti Surgical, Inc. | 2014-03-31 | 201 | 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