# Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

- Location (FDA's records): Marquette, MI
- FDA decisions: 16 (2015–2020): 16 510(k) clearances
- Names in FDA's records: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (9); Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. (6); Pioneer Surgical Technology, Inc., Dba Rti Surgical (1)
- Product codes: JDQ (4), OVE (2), NKG (2), MAX (2), NQW (1), HRS (1), OLO (1), KWP (1), KWQ (1), NKB (1)
- 510(k) review time since 2016: median 100 days, against 93 for FDA's reviews in the same codes and years (8 of 13 faster)
- Predicates its devices cite: 35 (6 its own); citations of its devices by later devices: 17 (6 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pioneer Surgical Technology: 8 (https://510kreport.com/company/pioneer-surgical-technology)
- Medtronic Sofamor Danek USA, Inc.: 3 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- DePuy Synthes: 2 (https://510kreport.com/company/depuy-synthes)
- Rti Surgical, Inc.: 2 (https://510kreport.com/company/rti-surgical)
- Depuy Spine, Inc.: 1 (https://510kreport.com/company/depuy-spine)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Pioneer Surgical Technology, Inc. (Rti Surgical, I: 1 (https://510kreport.com/company/pioneer-surgical-technology-rti-surgical-i)
- Medos International SARL: 1 (https://510kreport.com/company/medos-international)

## Firms that cite its devices most
- Paradigm Spine, LLC: 3 (https://510kreport.com/company/paradigm-spine)
- Corelink, LLC: 2 (https://510kreport.com/company/corelink)
- A & E Medical Corporation: 2 (https://510kreport.com/company/a-e-medical)
- Xtant Medical Holdings, Inc.: 1 (https://510kreport.com/company/xtant-medical-holdings)
- Pioneer Surgical Technology: 1 (https://510kreport.com/company/pioneer-surgical-technology)
- Precision Spine, Inc.: 1 (https://510kreport.com/company/precision-spine)
- Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices: 1 (https://510kreport.com/company/jm-longyear-manufacturing-dba-able-medical-devices)

## Its most-cited devices
- K152793: Unison-C Anterior Cervical Fixation System (2016), cited by 4
- K150581: Tritium Sternal Cable Plate System (2015), cited by 2
- K190498: Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System (2019), cited by 2
- K161876: Tritium® Sternal Cable Plate System (2016), cited by 2
- K193468: Tritium Sternal Cable Plate System (2020), cited by 1
- K150254: Streamline OCT Occipito-Cervico-Thoracic System (2015), cited by 1

## Recent decisions
- K201497: EVOS Cabling System (Oct 28, 2020)
- K200513: DAC Dynamic Active Compression Plate (Jul 22, 2020)
- K200095: Streamline Navigated Instruments (Jun 26, 2020)
- K193468: Tritium Sternal Cable Plate System (Mar 12, 2020)
- K192800: Streamline TL Spinal Fixation System (Jan 14, 2020)
- K192718: Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology (Dec 20, 2019)
- K190498: Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System (Jul 5, 2019)
- K183060: CervAlign™ Anterior Cervical Plate System (Jan 17, 2019)

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