Genesys Spine · Class II · Cleared Feb 7, 2025
| K-number | K242483 |
| Device name | Genesys Spine AIS-C II Cervical Interbody Fusion System |
| Applicant | Genesys Spine |
| Product code | OVE |
| Device class | Class II |
| Decision date | Feb 7, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The Genesys Spine AIS-C II Cervical Interbody Fusion System is a standalone anterior cervical interbody fusion device for skeletally mature patients with degenerative disc disease and radicular symptoms at one cervical level (C2-T1). It is used with autogenous bone graft and can be deployed with or without integrated fixation anchors, depending on whether supplemental external fixation is planned.
The device uses identical materials to its predicate: PEEK interbody with tantalum markers, titanium alloy locking mechanism, and titanium alloy anchors (when standalone version). Both subject and predicate devices feature the same design characteristics, manufacturing techniques (subtractive), sterilization method (non-sterile), and principles of operation. No new identifiable risks were introduced.
ASTM F2267-22 (load-induced subsidence under static axial compression), ASTM F2077-22 (interbody fusion device test methods), ASTM F1877-16 (particle characterization), ASTM F04.25.02.02 (static push-out test), ASTM F3292-19 (spinal implant inspection), and ISO 23089-2:2021 (preclinical mechanical assessment of spinal intervertebral fusion devices).
The subject device is substantially equivalent because it shares the same intended use (single-level cervical fusion for DDD with radicular symptoms), identical materials and material properties, identical design and locking mechanisms, and the same principles of operation as the primary predicate (K181295). Nonclinical mechanical testing demonstrates the device meets or exceeds predicate performance data and is safe and effective when compared to legally marketed predicates.
View the full FDA submission: accessdata.fda.gov