# K180822: VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Wenzel Spine, Inc.
- Decided: Jan 28, 2019 after 304 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 19 generations back to K841189 (1984). 241 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 247 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151900: VariLift-L Interbody Fusion Device, Wenzel Spine, Inc. (2015) Summary page 7.
- K160924: Amendia Interbody Fusion Devices, Amendia, Inc. (2016) Summary page 7.
- K120603: Varilift -C, Wenzel Spine (2013) Summary page 7.

## Most influential descendants
- K231076: VariLift®-C Interbody Fusion System (2023), 4 descendants of its own
- 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® Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. The Wenzel Spine VariLift Cervical 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 at the C3 to C7 disc levels using autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The Wenzel Spine VariLift Cervical Interbody Fusion System may 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. The Wenzel Spine VariLift® Interbody Fusion System (VariLift®-L/LX and VariLift®-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. VariLift®-L/LX is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift®-L/LX may be implanted with or without supplemental fixation and is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. VariLift®-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift®-A may be implanted with or without supplemental fixation and is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Source page: https://510kreport.com/device/K180822
Methodology: https://510kreport.com/methodology