# K252432: Flex-Z™ Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: Spinepoint, LLC
- Decided: Mar 25, 2026 after 236 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: 27 generations back to K841189 (1984). 502 ancestors in all.
No later device cites it as a predicate yet.
1 of 503 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223731: NuVasive Modulus-C Interbody System, Nuvasive, Inc. (2023) Summary page 5.
- K183705: IdentiTi Porous Ti Interbody System, Alphatec Spine, Inc. (2019) Summary page 5.
- K191812: ADI Cervical Interbody Fusion Device, Additive Device, Inc. (Adi) D/B/A Restor3D (2019) Summary page 5.

## Indications for use
The SpinePoint Flex-Z ™ Cervical Cage is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DOD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies) at multiple contiguous levels from C2-T1 spine using an anterior approach. The SpinePoint Flex-Z ™ Cervical Cage is intended to be used with supplemental fixation systems and with allograft/allogenic bone graft, comprised of cancellous, cortical, and corticocancellous bone to facilitate fusion. Patients should receive 6 weeks of non-operative treatment prior to treatment with the SpinePoint Flex-Z ™ Cervical Cage.

Source page: https://510kreport.com/device/K252432
Methodology: https://510kreport.com/methodology