# K183397: ChoiceSpine Stealth Cervical Spacer System

- Pathway: 510(k) (Special)
- Applicant: Choicespine, LP
- Decided: Mar 6, 2019 after 89 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: 21 generations back to K841189 (1984). 310 ancestors in all.
16 later devices descend from it; 3 cite it directly.
1 of 327 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091531: Choice Spine Cervical Interbody Spacer System Choice Spine Cervical Interbody Spacer, Choice Spine, Llp (2009) Summary page 5.
- K172816: TiGer Shark™ System, Choicespine, LP (2018) Summary page 5.
- K172676: NuVasive® Modulus-C Interbody System, Nu Vasive, Incorporated (2017) Summary page 5.

## Most influential descendants
- K202398: Ti3Z Cervical Interbody System (2021), 9 descendants of its own
- K221049: Zavation VariSync Plate System and VariSync Spacer System (2022), 6 descendants of its own
- K201643: ChoiceSpine Tiger Shark Cervical Spacer System (2020), 4 descendants of its own
- K231766: Skyway Anterior Cervical Plate System (2023), 3 descendants of its own
- K212811: Ti3Z Lumbar Interbody System (2022), 3 descendants of its own

## Indications for use
The ChoiceSpine Stealth™ 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 Stealth™ 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/K183397
Methodology: https://510kreport.com/methodology