# K192993: Scarlet AL-T

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Jan 22, 2020 after 89 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 20 generations back to K841189 (1984). 275 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 4.
- K170592: NuVasive BASE Interfixated Titanium System, Nu Vasive, Incorporated (2017) Summary page 4.

## Most influential descendants
- K242589: Scarlet® AL-T (2024), 0 descendants of its own

## 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. The Scarlet® AL-T Hyperlordotic (≥ 20°) cages are to be used with BOTH the integrated fixation by the mean of the bone screws provided and ALSO additional supplemental fixation system that has been cleared by the FDA for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K192993
Methodology: https://510kreport.com/methodology