# K153123: Genesys Spine Apache Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Apr 26, 2016 after 180 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: 16 generations back to K841189 (1984). 109 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 122 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 4.
- K082698: Aleutian Ibf System, K2m, Inc. (2009) Summary page 4.
- K130548: Epicage Interbody Fusion Device, Alphatec Spine, Inc. (2013) Summary page 4.
- K143143: Pathway Elif, Custom Spine, Inc. (2015) Summary page 4.
- K090353: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek (2009) Summary page 4.
- K111525: Perimeter Interbody Fusion Device, Medtronic Sofamor Danek (2011) Summary page 4.
- K133340: Spineworks Anterior Lumbar Device, Spineworks, LLC (2014) Summary page 4.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 4.

## Most influential descendants
- K161438: Genesys Spine Apache® Anterior Lumbar Interbody Fusion System (2016), 11 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 Apache® 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/K153123
Methodology: https://510kreport.com/methodology