# K230583: Tryptik Ti

- Pathway: 510(k) (Special)
- Applicant: Spineart SA
- Decided: Mar 22, 2023 after 20 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: 23 generations back to K841189 (1984). 392 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 394 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200312: Tryptik Ti, Spineart (2020) Summary page 4.
- K182284: Tyber Medical PT Interbody Spacer, Tyber Medical, LLC (2019) Summary page 4.

## Most influential descendants
- K240699: SCARLET® AC-Ti (2024), 0 descendants of its own

## Indications for use
TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK®Ti cages are used to facilitate intervertebral body fusion in the cervical spine using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. TRYPTIK®Ti cages are to be used with supplemental fixation that has been cleared for use in the cervical spine. 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/K230583
Methodology: https://510kreport.com/methodology