# X-Spine Systems, Inc.

- Location (FDA's records): Miamisburg, OH
- FDA decisions: 35 (2004–2018): 35 510(k) clearances
- Names in FDA's records: X-Spine Systems, Inc. (34); X-Spine Systems (1)
- Product codes: KWQ (7), ODP (4), MNH (3), MNI (3), MAX (3), KWP (3), OVE (2), OVD (2), MRW (2), OUR (2), PEK (1), NKG (1)
- 510(k) review time since 2016: median 101 days, against 110 for FDA's reviews in the same codes and years (5 of 10 faster)
- Predicates its devices cite: 75 (25 its own); citations of its devices by later devices: 96 (25 its own)
- Recalls linked to its devices: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Globus Medical, Inc.: 8 (https://510kreport.com/company/globus-medical)
- Medtronic Sofamor Danek: 4 (https://510kreport.com/company/medtronic-sofamor-danek)
- Synthes (Usa): 3 (https://510kreport.com/company/synthes-usa)
- Lanx, Inc.: 2 (https://510kreport.com/company/lanx)
- Spinefrontier, Inc.: 2 (https://510kreport.com/company/spinefrontier)
- Zyga Technology, Inc.: 2 (https://510kreport.com/company/zyga-technology)
- SI-BONE, Inc.: 2 (https://510kreport.com/company/si-bone)
- Aesculap Implant Systems, LLC: 2 (https://510kreport.com/company/aesculap-implant-systems)

## Firms that cite its devices most
- Reliance Medical Systems, LLC: 6 (https://510kreport.com/company/reliance-medical-systems)
- Spineart: 4 (https://510kreport.com/company/spineart)
- Pinnacle Spine Group, LLC: 3 (https://510kreport.com/company/pinnacle-spine-group)
- Spine Wave, Inc.: 3 (https://510kreport.com/company/spine-wave)
- Genesys Spine: 3 (https://510kreport.com/company/genesys-spine)
- Custom Spine, Inc.: 3 (https://510kreport.com/company/custom-spine)
- Nu Vasive, Incorporated: 2 (https://510kreport.com/company/nu-vasive)
- Ldr Spine USA: 2 (https://510kreport.com/company/ldr-spine-usa)

## Its most-cited devices
- K052292: Spider Cervical Plating (SCP) System (2005), cited by 15
- K112036: Calix PC Spinal Implant System (2011), cited by 12
- K130438: Axle Interspinous Fusion System (2013), cited by 6
- K123702: Silex Sacroiliac Joint Fusion System (2013), cited by 6
- K171075: Calix-C Cervical Interbody Spacer (2017), cited by 5
- K083637: Calix Spinal Implant System (2009), cited by 4

## Recent decisions
- K173832: InTice™-C Porous Ti Cervical Interbody System (May 17, 2018)
- K180153: X-spine Cortical Bone Screw System (Mar 15, 2018)
- K170119: Calix Lumbar Spinal Implant System (Sep 29, 2017)
- K171567: IRIX-A Lumbar Integrated Fusion System (Aug 28, 2017)
- K171075: Calix-C Cervical Interbody Spacer (Aug 1, 2017)
- K170224: Spider Cervical Plating System (Jul 6, 2017)
- K170530: Butrex Lumbar Buttress Plating System (Mar 22, 2017)
- K160959: Xsert Lumbar Expandable Interbody System (Nov 17, 2016)

Source page: https://510kreport.com/company/x-spine-systems