# K261049: Scala® TL

- Pathway: 510(k) (Traditional)
- Applicant: Spineart SA
- Decided: Aug 20, 2026 after 142 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: 22 generations back to K841189 (1984). 356 ancestors in all.
No later device cites it as a predicate yet.
1 of 357 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163364: MOJAVE Expandable Interbody System, K2m (2017) Summary page 5.
- K171633: NuVasive TLX Interbody System, Nu Vasive, Incorporated (2017) Summary page 5.
- K192115: SABLE Expandable Spacer, Globus Medical, Inc. (2020) Summary page 5.
- K153621: Juliet® Ti, Spineart (2016) Summary page 5.
- K181203: Juliet Ti, Spineart (2018) Summary page 5.

## Indications for use
The SCALA® TL Posterior Expandable Cage System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L1-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. It is used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental spinal fixation system that is cleared for use in the lumbosacral spine. Additionally, the SCALA® TL Posterior Expandable Cage System can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

Source page: https://510kreport.com/device/K261049
Methodology: https://510kreport.com/methodology