# K122366: Tryptik CC Anterior Intersomatic Cervical Cage

- Pathway: 510(k) (Special)
- Applicant: Spineart
- Decided: Oct 4, 2012 after 59 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: 11 generations back to K841189 (1984). 45 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091873: Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-S, Spineart (2009) Summary page 1.
- K101302: Aleutian Ibf System, K2m, Inc. (2010) Summary page 1.

## Cited in the summary but kept off the family tree
- K107351: Crystal. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K200312: Tryptik Ti (2020), 2 descendants of its own
- K172065: Scarlet AC-T (2017), 2 descendants of its own
- K230583: Tryptik Ti (2023), 1 descendant of its own
- K190322: SCARLET® AC-T Secured Anterior Cervical Cage (2019), 1 descendant of its own
- K240699: SCARLET® AC-Ti (2024), 0 descendants of its own

## Indications for use
TRYPTIK® 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. TRYPTIK® cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK® cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment

Source page: https://510kreport.com/device/K122366
Methodology: https://510kreport.com/methodology