# K150812: Genesys Spine Apache Cervical Interbody Fusion System

- Pathway: 510(k) (Abbreviated)
- Applicant: Genesys Spine
- Decided: Sep 3, 2015 after 161 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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.
12 later devices descend from it; 2 cite it directly.
0 of 49 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.
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 4.

## Most influential descendants
- K191489: Genesys Spine 3DP Cervical Interbody System (2020), 7 descendants of its own
- K201643: ChoiceSpine Tiger Shark Cervical Spacer System (2020), 4 descendants of its own
- K211417: F3D-C2 Cervical Stand-Alone System (2022), 3 descendants of its own
- K203311: ChoiceSpine Blackhawk Ti Cervical Spacer System (2021), 3 descendants of its own
- K233594: Genesys Spine 3DP AIS-C II Cervical Interbody System (2023), 2 descendants of its own

## Indications for use
When used as a cervical intervertebral body fusion device, the Genesys Spine Apache™ Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K150812
Methodology: https://510kreport.com/methodology