# K242589: Scarlet® AL-T

- Pathway: 510(k) (Traditional)
- Applicant: Spineart SA
- Decided: Oct 23, 2024 after 54 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 21 generations back to K841189 (1984). 276 ancestors in all.
No later device cites it as a predicate yet.
1 of 277 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181818: Scarlet AL-T, Spineart (2018) Summary page 5.
- K192993: Scarlet AL-T, Spineart (2020) Summary page 5.

## Indications for use
The SCARLET® AL-T system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous and /or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. When used with the integrated fixation by the mean of the bone screws provided, the SCARLET® AL-T is a stand-alone system and requires no additional supplemental fixation system. When used as a lumbar intervertebral fusion device (i.e. without the bone screws provided), the SCARLET® AL-T interbody device must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K242589
Methodology: https://510kreport.com/methodology