# K131296: Varilift-L Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Wenzel Spine, Inc.
- Decided: Sep 3, 2013 after 120 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: 12 generations back to K841189 (1984). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 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 2.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 2.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 2.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 2.
- K111525: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek (2011) Summary page 2.
- K090353: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek (2009) Summary page 2.

## Indications for use
The Wenzei Spine VaniLift Interbody Fusion System (VariLift-L and VaniLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to Si, 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 (DOD) with up to Grade I spondylolisthesis. DD 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. VaniLift-A is designed to be implanted bi-laterally via an anterior (ALIF) approach. VariLift-L and VaniLift-Amay be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K131296
Methodology: https://510kreport.com/methodology