# K181203: Juliet Ti

- Pathway: 510(k) (Special)
- Applicant: Spineart
- Decided: Jun 28, 2018 after 52 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: 16 generations back to K841189 (1984). 136 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 138 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153621: Juliet® Ti, Spineart (2016) Summary page 4.

## Most influential descendants
- K261049: Scala® TL (2026), 0 descendants of its own

## Indications for use
Juliet® Ti PO, OL & TL lumbar interbody devices are 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 bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Juliet® Ti lumbar interbody devices are to be used with supplemental fixation that has been cleared for use in the lumbosacral spine. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K181203
Methodology: https://510kreport.com/methodology