# K130913: Genesys Spine Apache Lateral Lumbar Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Genesys Spine
- Decided: Dec 13, 2013 after 255 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: 11 generations back to K841189 (1984). 36 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103034: Genesys Spine Interbody Fusion System, Genesys Spine (2010) Summary page 1.

## Most influential descendants
- K161404: Genesys Spine Apache® Lateral Lumbar Interbody Fusion System (2016), 10 descendants of its own
- K182987: Genesys Spine 3DP Lumbar Interbody System (2019), 9 descendants of its own
- K191489: Genesys Spine 3DP Cervical Interbody System (2020), 7 descendants of its own
- K211417: F3D-C2 Cervical Stand-Alone System (2022), 3 descendants of its own
- K233594: Genesys Spine 3DP AIS-C II Cervical Interbody System (2023), 2 descendants of its own

## Indications for use
The Genesys Spine ApacheTM Lateral Lumbar 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/K130913
Methodology: https://510kreport.com/methodology