# K203327: VERTACONNECT TLIF Cage

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik
- Decided: Jan 25, 2021 after 74 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: 20 generations back to K841189 (1984). 167 ancestors in all.
No later device cites it as a predicate yet.
1 of 168 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172756: Varian cage, Medyssey USA, Inc. (2017) Summary page 4.
- K172696: FORZA® XP Expandable Spacer System, Orthofix, Inc. (2018) Summary page 4.
- K083626: Distractable Wave Cage, Advanced Medical Technology, Inc. (2009) Summary page 4.

## Indications for use
The VERTACONNECT TLIF cage is indicated for inter-vertebral 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. 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/K203327
Methodology: https://510kreport.com/methodology