# K231076: VariLift®-C Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Wenzel Spine, Inc.
- Decided: Sep 27, 2023 after 166 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: 26 generations back to K841189 (1984). 412 ancestors in all.
4 later devices descend from it; 2 cite it directly.
1 of 417 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222276: CONDUIT Cages; FIBERGRAFT BG Putty, Depuy Spine (2022) Summary page 4.
- K180822: VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System, Wenzel Spine, Inc. (2019) Summary page 4.

## Most influential descendants
- K240830: Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; FORZA XP Expandable Spacer System; Shoreline ACS Interbody System; Shoreline RT Interbody System; Meridian Interbody System; WaveForm A Interbody System (2024), 2 descendants of its own
- K262595: VariLift-C Cervical Interbody Fusion System (2026), 0 descendants of its own
- K253420: Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (2026), 0 descendants of its own
- K251617: X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System (2025), 0 descendants of its own

## 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. When used at one disc level, the Wenzel Spine VariLift-C interbody Fusion System may be used with or without supplemental fixation. When used at multiple contiguous levels, the Wenzel Spine VariLift-C Interbody Fusion System is intended to be used with 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/K231076
Methodology: https://510kreport.com/methodology