# Pioneer Surgical Technology

- Location (FDA's records): Marquette, MI
- FDA decisions: 77 (1993–2026): 77 510(k) clearances
- Names in FDA's records: Pioneer Surgical Technology (50); Pioneer Surgical Technology, Inc. (27)
- Product codes: JDQ (13), NKB (13), KWQ (12), MQV (7), HWC (6), KWP (5), MAX (3), HRS (3), MNI (3), MQP (3), HTN (2), NQW (1)
- 510(k) review time since 2016: median 74 days, against 74 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 168 (83 its own); citations of its devices by later devices: 218 (83 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 13 (https://510kreport.com/company/synthes-usa)
- Depuy Spine, Inc.: 6 (https://510kreport.com/company/depuy-spine)
- Nuvasive, Inc.: 5 (https://510kreport.com/company/nuvasive)
- Orthovita, Inc.: 5 (https://510kreport.com/company/orthovita)
- Medtronic Sofamor Danek: 4 (https://510kreport.com/company/medtronic-sofamor-danek)
- ETHICON, Inc.: 4 (https://510kreport.com/company/ethicon)
- Synthes Spine: 4 (https://510kreport.com/company/synthes-spine)
- Howmedica Corp.: 3 (https://510kreport.com/company/howmedica)

## Firms that cite its devices most
- Rti Surgical, Inc. Dba Rti Biologics: 12 (https://510kreport.com/company/rti-surgical-dba-rti-biologics)
- Reliance Medical Systems, LLC: 11 (https://510kreport.com/company/reliance-medical-systems)
- Zimmer, Inc.: 10 (https://510kreport.com/company/zimmer)
- Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.): 8 (https://510kreport.com/company/pioneer-surgical-technology-dba-rti-surgical)
- Frontier Medical Devices, Inc.: 8 (https://510kreport.com/company/frontier-medical-devices)
- Smith & Nephew, Inc.: 4 (https://510kreport.com/company/smith-nephew)
- Kinamed, Inc.: 4 (https://510kreport.com/company/kinamed)
- Life Spine, Inc.: 3 (https://510kreport.com/company/life-spine)

## Its most-cited devices
- K073177: Pioneer Intervertebral Fusion Device System (2008), cited by 12
- K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer) (2005), cited by 12
- K102903: Pioneer Cannulated Screw System (2010), cited by 10
- K935481: Sponger Cable System, Modification (1994), cited by 9
- K070973: Quantum Spinal System (2007), cited by 8
- K990804: Stayfuse (1999), cited by 8

## Recent decisions
- K261271: Cable-Ready® Cable Grip System (Jul 16, 2026)
- K251436: Resolve Anterior Cervical Plate System (Jul 11, 2025)
- K222493: CODA™ Anterior Cervical Plate System (Nov 18, 2022)
- K211408: CervAlign® Anterior Cervical Plate System (Jun 23, 2021)
- K192396: Streamline MIS Spinal Fixation System (Nov 26, 2019)
- K140696: Streamline TL Spinal Fixation System (Apr 10, 2014)
- K133455: Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic (Mar 27, 2014)
- K133623: C-PLUS (Feb 10, 2014)

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