# K172756: Varian cage

- Pathway: 510(k) (Traditional)
- Applicant: Medyssey USA, Inc.
- Decided: Dec 8, 2017 after 86 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: 15 generations back to K841189 (1984). 80 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 82 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 4.
- K132505: Acculif TL and PL Cage, Coalign Innovations, Inc. (2013) Summary page 4.
- K093669: Sec Ibf Cage, Innvotec Surgical, Inc. (2010) Summary page 4.
- K140564: BN Lumbar Cage System, Medyssey USA, Inc. (2014) Summary page 4.
- K140577: Innesis Peek TL Cage, Bk Meditech, Co., Ltd. (2014) Summary page 4.
- K121246: Medyssy LT Cage System, Medyssey Co, Ltd. (2012) Summary page 4.

## Most influential descendants
- K203327: VERTACONNECT TLIF Cage (2021), 0 descendants of its own

## Indications for use
The Varian cage 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. Varian cage is designed to be implanted bi-laterally via a posterior (PLIF) approach. The device is intended for use with supplemental fixation and is intended for use with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K172756
Methodology: https://510kreport.com/methodology