# K171489: Acapella Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Choicespine, LP
- Decided: Oct 23, 2017 after 154 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). 88 ancestors in all.
39 later devices descend from it; 4 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132582: Exactech Acapella One Cervical Spacer System, Exactech, Inc. (2014) Summary page 4.
- K170953: Tomcat Cervical Spinal System, Choicespine, LP (2017) Summary page 5.

## Most influential descendants
- K200087: F3D Cervical Stand-Alone Interbody Fusion System (2020), 25 descendants of its own
- K212853: Cervical Stand-Alone System (2021), 18 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
- K232530: Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (2023), 5 descendants of its own

## Indications for use
The Choice Spine Acapella Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Choice Spine Acapella Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

Source page: https://510kreport.com/device/K171489
Methodology: https://510kreport.com/methodology