# K152099: Genesys Spine Apache® Anchored Cervical Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Genesys Spine
- Decided: Jul 28, 2016 after 366 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 13 generations back to K841189 (1984). 58 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 4.
- K113559: LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants, Ldr Spine USA, Inc. (2011) Summary page 4.
- K132582: Exactech Acapella One Cervical Spacer System, Exactech, Inc. (2014) Summary page 4.

## Most influential descendants
- K180056: Genesys Spine AIS-C Cervical Anchored Interbody System (2018), 18 descendants of its own
- K181295: Genesys Spine AIS-C Cervical Stand-Alone System (2018), 17 descendants of its own
- K191489: Genesys Spine 3DP Cervical Interbody System (2020), 7 descendants of its own
- K181621: Stable-C Interbody System (2018), 7 descendants of its own
- K231763: Stable-C Interbody System (2023), 6 descendants of its own

## Indications for use
The Genesys Spine Apache® Anchored Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2–T1. 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. These patients should have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K152099
Methodology: https://510kreport.com/methodology