# K201643: ChoiceSpine Tiger Shark Cervical Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Choice Spine, LLC
- Decided: Dec 22, 2020 after 188 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
Longest line of descent: 22 generations back to K841189 (1984). 313 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 318 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150812: Genesys Spine Apache Cervical Interbody Fusion System, Genesys Spine (2015) Summary page 5.
- K183397: ChoiceSpine Stealth Cervical Spacer System, Choicespine, LP (2019) Summary page 4.

## Most influential descendants
- K203311: ChoiceSpine Blackhawk Ti Cervical Spacer System (2021), 3 descendants of its own
- 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 Tiger Shark Cervical Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc space 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 TiGER SHARK Cervical Spacer System is to be used with supplemental fixation and with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion.

Source page: https://510kreport.com/device/K201643
Methodology: https://510kreport.com/methodology