# Rti Surgical, Inc.

- Location (FDA's records): Alachua, FL
- FDA decisions: 7 (2014–2025): 7 510(k) clearances
- Product codes: GAT (2), FTM (1), MQV (1), GXQ (1), ODP (1), MAX (1)
- 510(k) review time since 2016: median 147 days, against 104 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 12 (1 its own); citations of its devices by later devices: 8 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bio-Vascular, Inc.: 2 (https://510kreport.com/company/bio-vascular)
- Musculoskeletal Transplant Foundation: 1 (https://510kreport.com/company/musculoskeletal-transplant-foundation)
- Allosource, Inc.: 1 (https://510kreport.com/company/allosource)
- Rti Biologics, Inc.: 1 (https://510kreport.com/company/rti-biologics)
- Exactech, Inc.: 1 (https://510kreport.com/company/exactech)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)
- Collagen Matrix, Inc.: 1 (https://510kreport.com/company/collagen-matrix)
- Pioneer Surgical Technology: 1 (https://510kreport.com/company/pioneer-surgical-technology)

## Firms that cite its devices most
- Vy Spine, LLC: 2 (https://510kreport.com/company/vy-spine)
- Paradigm Spine, LLC: 2 (https://510kreport.com/company/paradigm-spine)
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.): 2 (https://510kreport.com/company/pioneer-surgical-technology-dba-rti-surgical)
- Implanet, S.A.: 1 (https://510kreport.com/company/implanet)

## Its most-cited devices
- K163673: Fortilink™-C with TETRAfuse™ 3D Technology (2017), cited by 4
- K172343: Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology (2017), cited by 3
- K230036: Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) (2023), cited by 1

## Recent decisions
- K253145: Pre-Sutured Tendon (Oct 22, 2025)
- K241555: Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (Feb 21, 2025)
- K230036: Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) (Jun 23, 2023)
- K172343: Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology (Oct 23, 2017)
- K163673: Fortilink™-C with TETRAfuse™ 3D Technology (May 23, 2017)
- K142070: Fortiva Porcine Dermis, Tutoplast Porcine Dermis (Oct 27, 2014)
- K132850: Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine Pericardium DM (Mar 31, 2014)

Source page: https://510kreport.com/company/rti-surgical