# K223231: Ti-Largo Cervical Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Flospine
- Decided: Feb 24, 2023 after 129 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). 274 ancestors in all.
No later device cites it as a predicate yet.
1 of 275 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193255: Largo PEEK Interbody System, Flospine, LLC (2020) Summary page 4.
- K193359: SureMAX Family of Cervical Spacers, Additive Implants, Inc. (2020) Summary page 4.

## Indications for use
Ti-Largo™ Cervical Interbody Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Ti-Largo™ Cervical Interbody Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. Ti-Largo™ Cervical Interbody Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K223231
Methodology: https://510kreport.com/methodology