# K172065: Scarlet AC-T

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Sep 29, 2017 after 84 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: 16 generations back to K841189 (1984). 133 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143214: SCARLET® AC-T Secured Anterior Cervical Cage, Spineart (2015) Summary page 4.
- K141314: Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation, Spineart (2014) Summary page 4.
- K122366: Tryptik CC Anterior Intersomatic Cervical Cage, Spineart (2012) 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.
- K153373: CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device, Medtronic Sofamor Danek (2016) Summary page 4.

## Most influential descendants
- 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
SCARLET® AC-T cages are indicated for use in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. SCARLET® AC-T cages are intended to be used at one level from the C2-C3 disc to the C7-T1 disc to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The SCARLET® AC-T Secured Anterior Cervical Cage is intended to be used as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. When used without the two bone screws, SCARLET AC-T cages are to be used with supplemental fixation which has been cleared by the FDA for use in the cervical spine.

Source page: https://510kreport.com/device/K172065
Methodology: https://510kreport.com/methodology