# K223869: ChoiceSpine Blackhawk Ti Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Choice Spine, LLC
- Decided: Sep 14, 2023 after 265 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: 24 generations back to K841189 (1984). 458 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 461 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170953: Tomcat Cervical Spinal System, Choicespine, LP (2017) Summary page 5.
- K203311: ChoiceSpine Blackhawk Ti Cervical Spacer System, Choice Spine, LLC (2021) Summary page 4.

## Most influential descendants
- K261882: Pisces-SC Standalone Cervical Interbody System (2026), 0 descendants of its own
- K240699: SCARLET® AC-Ti (2024), 0 descendants of its own

## Indications for use
The Blackhawk Ti Cervical Spacer System is a stand-alone anterior cervical interbody fusion device indicated for use in a skeletally mature patient with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. 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 Blackhawk Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, to facilitate fusion.

Source page: https://510kreport.com/device/K223869
Methodology: https://510kreport.com/methodology