# SI-BONE, Inc.

- Location (FDA's records): Santa Clara, CA
- FDA decisions: 33 (2008–2026): 33 510(k) clearances
- Product codes: OUR (27), OLO (4), PDQ (1), NKB (1)
- 510(k) review time since 2016: median 96 days, against 91 for FDA's reviews in the same codes and years (13 of 23 faster)
- Predicates its devices cite: 122 (95 its own); citations of its devices by later devices: 133 (95 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Globus Medical, Inc.: 3 (https://510kreport.com/company/globus-medical)
- SeaSpine Orthopedics Corporation: 2 (https://510kreport.com/company/seaspine-orthopedics)
- Synthes (USA) Products, LLC: 2 (https://510kreport.com/company/synthes-usa-products)
- Medtronic, Inc.: 1 (https://510kreport.com/company/medtronic)
- Spinecraft, LLC: 1 (https://510kreport.com/company/spinecraft)
- Pioneer Surgical Technology: 1 (https://510kreport.com/company/pioneer-surgical-technology)
- Precision Spine, Inc.: 1 (https://510kreport.com/company/precision-spine)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)

## Firms that cite its devices most
- Genesys Spine: 4 (https://510kreport.com/company/genesys-spine)
- Medtronic Sofamor Danek: 4 (https://510kreport.com/company/medtronic-sofamor-danek)
- Life Spine, Inc.: 3 (https://510kreport.com/company/life-spine)
- Corelink, LLC: 3 (https://510kreport.com/company/corelink)
- Tenon Medical: 2 (https://510kreport.com/company/tenon-medical)
- Orthofix, Inc.: 2 (https://510kreport.com/company/orthofix)
- Nexxt Spine, LLC: 2 (https://510kreport.com/company/nexxt-spine)
- X-Spine Systems, Inc.: 2 (https://510kreport.com/company/x-spine-systems)

## Its most-cited devices
- K092375: Modification to SI Joint Fusion System (2009), cited by 14
- K110838: Ifuse Implant System (2011), cited by 11
- K080398: SI Joint Fusion System (2008), cited by 11
- K131405: Ifuse Implant System (2013), cited by 10
- K193524: SI-BONE iFuse Implant System® (2020), cited by 9
- K122074: Ifuse Implant System (2012), cited by 9

## Recent decisions
- K262067: iFuse Granite Onyx™ Implant System (Sep 23, 2026)
- K253488: iFuse INTRA Ti™ Implant System (Feb 11, 2026)
- K253094: iFuse Bedrock Granite Implant System (Oct 9, 2025)
- K251780: iGPS Navigation Instruments (Sep 15, 2025)
- K241504: iFuse TORQ TNT™ Implant System (Aug 19, 2024)
- K241574: iFuse TORQ® Implant System (Jul 2, 2024)
- K232800: Navigation Tracking Instruments (Feb 23, 2024)
- K233508: iFuse Bedrock Granite® Implant System (Jan 26, 2024)

Source page: https://510kreport.com/company/si-bone