# K141314: Scarlet AC-T Secured Anterior Cervical Cage and Associated Instrumentation

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Sep 29, 2014 after 132 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: 14 generations back to K841189 (1984). 111 ancestors in all.
38 later devices descend from it; 6 cite it directly.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120819: Stalif C, Centinel Spine, Inc. (2012) Summary page 4.
- K111439: Chesapeake (Cervical Components), K2m, Inc. (2011) Summary page 4.
- K112459: Synthes Zero-P, Synthes Spine Co.Lp (2011) Summary page 4.
- K102606: Avs Anchor-C Cervical Cage System, Stryker Spine (2011) Summary page 4.

## Most influential descendants
- K180056: Genesys Spine AIS-C Cervical Anchored Interbody System (2018), 18 descendants of its own
- K181295: Genesys Spine AIS-C Cervical Stand-Alone System (2018), 17 descendants of its own
- K193000: Hexanium® ACIF (2020), 14 descendants of its own
- K211111: SureMAX-SA Cervical Standalone System (2021), 8 descendants of its own
- K191489: Genesys Spine 3DP Cervical Interbody System (2020), 7 descendants of its own

## Indications for use
The SCARLET®AC-T is intended to be used as an intervertebral body fusion cage as a standalone system used with the two bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. SCARLET®AC-T is intended to be used at one level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage

Source page: https://510kreport.com/device/K141314
Methodology: https://510kreport.com/methodology