# K151900: VariLift-L Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Wenzel Spine, Inc.
- Decided: Dec 11, 2015 after 154 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: 10 generations back to K841189 (1984). 30 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100820: Wenzel Spine Varilift Interbody Fusion System, Wenzel Spine (2010) Summary page 4.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 5.

## Most influential descendants
- K180822: VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System (2019), 5 descendants of its own
- 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
- K172756: Varian cage (2017), 1 descendant of its own
- K262595: VariLift-C Cervical Interbody Fusion System (2026), 0 descendants of its own

## Indications for use
The Wenzel Spine VariLift® Interbody Fusion System (VariLift®-L 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 is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift®-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift®-L and VariLift®-A may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K151900
Methodology: https://510kreport.com/methodology
