Rti Surgical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Rti Surgical, Inc.” (first 2014, latest 2025), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 147 days. Since 2017 the median was 147 days, against 107 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 2 | 145 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 114 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 178 |
| 2024 | 0 | — |
| 2025 | 2 | 146 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Rti Surgical, Inc. took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 | 2 |
| FTM | Mesh, Surgical | 1 | 1 |
| GXQ | Dura Substitute | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (3)
- General and Plastic Surgery (3)
- Neurology (1)
Most recent Rti Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253145 | Pre-Sutured Tendon | GAT | 2025-10-22 | 27 |
| K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCC | MQV | 2025-02-21 | 266 |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) | GAT | 2023-06-23 | 178 |
| K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology | MAX | 2017-10-23 | 82 |
| K163673 | Fortilink-C with TETRAfuse 3D Technology | ODP | 2017-05-23 | 147 |
| K142070 | FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS | FTM | 2014-10-27 | 89 |
| K132850 | BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM | GXQ | 2014-03-31 | 201 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2017-01-23.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Rti Surgical, Inc. is the lead sponsor of 8 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06456554: Acellular Dermal Matrix Investigation in Breast Reconstruction (Recruiting, started 2024-11-22)
- NCT06101979: A Prospective Study of Fortiva in Hernia Repair (Enrolling by invitation, started 2023-11-15)
- NCT04171544: Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up (Completed, started 2019-08-06)
- NCT03744013: A Post Market Prospective Study of FORTIVA® 1mm Porcine Dermis (Completed, started 2019-05-07)
- NCT03699891: Evaluation of the Fortilink IBF System With TETRAfuse Technology (Completed, started 2018-11-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rti Surgical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Rti Surgical, Inc.” (first 2014, latest 2025), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rti Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rti Surgical, Inc. is 147 days. Since 2017: 147 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Rti Surgical, Inc.?
The most frequent FDA product codes under this applicant name are GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 2); FTM (Mesh, Surgical, 1); GXQ (Dura Substitute, 1).
Next steps
- See all 7 Rti Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GAT, Rti Surgical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.