# K230026: Squale

- Pathway: 510(k) (Traditional)
- Applicant: Implanet, S.A.
- Decided: Mar 28, 2023 after 83 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). 507 ancestors in all.
No later device cites it as a predicate yet.
1 of 508 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142251: AVS AS PEEK Spacer, Stryker Corporation (2014) Summary page 4.
- K212358: Romero Cervical Cage, Spineup, Inc. (2022) Summary page 4.
- K163673: Fortilink™-C with TETRAfuse™ 3D Technology, Rti Surgical, Inc. (2017) Summary page 4.

## Indications for use
The SQUALE devices are indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The SQUALE devices are to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and are to be implanted via an open, anterior approach. The SQUALE devices are intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine. This cervical device is to be used in patients who have had six weeks of non-operative treatment.

Source page: https://510kreport.com/device/K230026
Methodology: https://510kreport.com/methodology