# K161404: Genesys Spine Apache® Lateral Lumbar Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Genesys Spine
- Decided: Jul 21, 2016 after 62 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). 120 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130913: Genesys Spine Apache Lateral Lumbar Interbody Fusion System, Genesys Spine (2013) Summary page 4.
- K103034: Genesys Spine Interbody Fusion System, Genesys Spine (2010) Summary page 4.
- K120368: Capstone Control Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 4.
- K151406: Cogent Lateral Interbody System, Cogent Spine, LLC (2016) Summary page 4.

## Most influential descendants
- 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
- K251735: Stabilis SA Cervical Stand-Alone System (Various PNs) (2025), 1 descendant of its own

## Indications for use
The Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System 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 1 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/K161404
Methodology: https://510kreport.com/methodology