# K190877: Juliet® Ti LL Lumbar Interbody Device

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: May 29, 2019 after 55 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K841189 (1984). 209 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 211 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.
- K173702: Juliet Ti LL, Spineart (2018) Summary page 4.
- K163543: Biomet Fusion System, Zimmer Biomet Spine, Inc. (2017) Summary page 4.

## Most influential descendants
- K241321: Juliet® Ti LL Lumbar Interbody Device (2024), 0 descendants of its own

## Recalls of this device
- Mar 16, 2023 · Class II · Z-1426-2023: JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant hol

## 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 L.2-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/K190877
Methodology: https://510kreport.com/methodology