# K241321: Juliet® Ti LL Lumbar Interbody Device

- Pathway: 510(k) (Traditional)
- Applicant: Spineart SA
- Decided: Jul 18, 2024 after 69 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: 19 generations back to K841189 (1984). 210 ancestors in all.
No later device cites it as a predicate yet.
1 of 211 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190877: Juliet® Ti LL Lumbar Interbody Device, Spineart (2019) Summary page 5.
- K173702: Juliet Ti LL, Spineart (2018) Summary page 5.

## Indications for use
JULIET® Ti LL Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) 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). The JULIET® Ti LL Lumbar Interbody Device 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. Implants with 15-degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least two integrated fixation screws. The JULIET® Ti LL implants 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/K241321
Methodology: https://510kreport.com/methodology