# K091531: Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Choice Spine, Llp
- Decided: Nov 2, 2009 after 160 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
No predicates in its family tree.
361 later devices descend from it; 5 cite it directly.
0 of 362 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K101171: Orthovita Peek Spacer (2011), 225 descendants of its own
- K120486: Avs as Peek Spacer (2012), 224 descendants of its own
- K120345: Honour Spacer System (2012), 212 descendants of its own
- K142251: AVS AS PEEK Spacer (2014), 161 descendants of its own
- K171140: Matrixx System (2017), 145 descendants of its own

## Indications for use
The Choice Spine Cervical Interbody Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in skeletally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is to be used with supplemental fixation and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K091531
Methodology: https://510kreport.com/methodology