# K262595: VariLift-C Cervical Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Wenzel Spine, Inc.
- Decided: Aug 26, 2026 after 30 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 27 generations back to K841189 (1984). 413 ancestors in all.
No later device cites it as a predicate yet.
1 of 414 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231076: VariLift®-C Interbody Fusion System, Wenzel Spine, Inc. (2023) Summary page 5.

## Indications for use
The Wenzel Spine VariLift-C Interbody Fusion System is indicated for use in skeletally mature patients with cervical disc degeneration (DDD) and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy, and/or pain at one or multiple contiguous levels from C2/C3 to C7/T1. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Wenzel Spine VariLift-C Interbody Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed in a unilateral or a bilateral fashion via an anterior approach using autogenous and/or allogeneic bone graft comprised of cancellous, and/or corticocancellous bone graft, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Wenzel Spine VariLift-C Interbody Fusion System is to be used with or without supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

Source page: https://510kreport.com/device/K262595
Methodology: https://510kreport.com/methodology