# K200312: Tryptik Ti

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Apr 6, 2020 after 60 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). 302 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 305 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171496: Tritanium C Anterior Cervical Cage, Stryker Spine (2017) Summary page 4.
- K091873: Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-S, Spineart (2009) Summary page 4.
- K122366: Tryptik CC Anterior Intersomatic Cervical Cage, Spineart (2012) Summary page 4.
- K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 4.
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 4.
- K153621: Juliet® Ti, Spineart (2016) Summary page 4.

## Most influential descendants
- K230583: Tryptik Ti (2023), 1 descendant of its own
- 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 is 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 is 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/K200312
Methodology: https://510kreport.com/methodology