Sync Surgical · Class II · Cleared Jan 14, 2026
| K-number | K252219 |
| Device name | Cervical Interbody and VBR Fusion System |
| Applicant | Sync Surgical |
| Product code | ODP |
| Device class | Class II |
| Decision date | Jan 14, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The Sync Cervical Interbody and VBR Fusion System is used for spinal fusion surgery in the cervical and thoracic spine. The interbody component treats degenerative disc disease at one disc level (C2-T1), while the vertebral body replacement (VBR) component replaces collapsed or damaged vertebrae due to tumor, trauma, or corpectomy. Both are used with supplemental fixation and bone graft to facilitate fusion in skeletally mature patients.
The devices are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or PEEK conforming to ASTM F2026, with tantalum marker pins (ASTM F560) for radiographic visualization. Components are available in multiple heights and footprints to accommodate individual patient anatomy and pathology.
Mechanical testing per FDA Spinal Systems Guidance and product codes ODP, PLR, and MQP. Testing included static and dynamic axial compression and torsion per ASTM F2077, subsidence per ASTM F2267, and expulsion testing on worst-case devices.
The subject device is substantially equivalent to predicate devices (Summit Spine Channel Cervical Interbody Fusion System, Omnia Medical VBR, and Pantheon Pedicle Screw System) because it has the same indications for use, identical technological characteristics, and demonstrates equivalent mechanical performance based on standardized testing.
View the full FDA submission: accessdata.fda.gov