# K203311: ChoiceSpine Blackhawk Ti Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Choice Spine, LLC
- Decided: May 10, 2021 after 181 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: 23 generations back to K841189 (1984). 457 ancestors in all.
3 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)
- K191621: ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System, Choice Spine, LLC (2019) Summary page 5.
- K171489: Acapella Cervical Spacer System, Choicespine, LP (2017) Summary page 5.
- K170953: Tomcat Cervical Spinal System, Choicespine, LP (2017) Summary page 5.
- K132582: Exactech Acapella One Cervical Spacer System, Exactech, Inc. (2014) Summary page 5.
- K201643: ChoiceSpine Tiger Shark Cervical Spacer System, Choice Spine, LLC (2020). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K223869: ChoiceSpine Blackhawk Ti Cervical Spacer System (2023), 2 descendants of its own
- 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 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 Blackhawk™ Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous 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/K203311
Methodology: https://510kreport.com/methodology