# K240699: SCARLET® AC-Ti

- Pathway: 510(k) (Traditional)
- Applicant: Spineart SA
- Decided: May 10, 2024 after 57 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 25 generations back to K841189 (1984). 541 ancestors in all.
No later device cites it as a predicate yet.
1 of 542 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141314: Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation, Spineart (2014) Summary page 4.
- K143214: SCARLET® AC-T Secured Anterior Cervical Cage, Spineart (2015) Summary page 4.
- K172065: Scarlet AC-T, Spineart (2017) Summary page 4.
- K190322: SCARLET® AC-T Secured Anterior Cervical Cage, Spineart (2019) Summary page 4.
- K200312: Tryptik Ti, Spineart (2020) Summary page 4.
- K230583: Tryptik Ti, Spineart SA (2023) Summary page 4.
- K203311: ChoiceSpine Blackhawk Ti Cervical Spacer System, Choice Spine, LLC (2021) Summary page 4.
- K223869: ChoiceSpine Blackhawk Ti Cervical Spacer System, Choice Spine, LLC (2023) Summary page 4.
- K192570: Atlas Spine Expandable Cervical Standalone Interbody System, Atlas Spine, Inc. (2020) Summary page 4.

## Indications for use
SCARLET® AC-Ti 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-Ti cages are intended to be used at one or two contiguous levels from C2-T1 to facilitate intervertebral body fusion with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used with two bone screws, the SCARLET® AC-Ti Secured Anterior Cervical Cage is intended to be used as a standalone system and requires no additional supplementary fixation systems. When used with two anchors or without two bone screws, the SCARLET® AC-Ti cages are to be used with supplemental fixation which has been cleared by the FDA for use in the cervical spine. The SCARLET® AC-Ti hyperlordotic (12° lordosis) cages are to be used with bone screws and/or anchors and additional supplemental fixation system that has been cleared by the FDA for use in the cervical spine.

Source page: https://510kreport.com/device/K240699
Methodology: https://510kreport.com/methodology