# K171656: Genesys Spine Apache Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Genesys Spine
- Decided: Jul 13, 2017 after 38 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: 18 generations back to K841189 (1984). 121 ancestors in all.
No later device cites it as a predicate yet.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161438: Genesys Spine Apache® Anterior Lumbar Interbody Fusion System, Genesys Spine (2016) Summary page 4.
- K103034: Genesys Spine Interbody Fusion System, Genesys Spine (2010) Summary page 4.
- K130913: Genesys Spine Apache Lateral Lumbar Interbody Fusion System, Genesys Spine (2013) Summary page 4.
- K153123: Genesys Spine Apache Interbody Fusion System, Genesys Spine (2016) Summary page 4.
- K080058: Turbo Prime Ibd System, Spineselect, LLC (2008) Summary page 4.

## Indications for use
The Genesys Spine Apache® Interbody Fusion System 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 (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K171656
Methodology: https://510kreport.com/methodology