# K173702: Juliet Ti LL

- Pathway: 510(k) (Special)
- Applicant: Spineart
- Decided: Jan 3, 2018 after 30 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). 152 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 155 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.
- K161888: JULIET® LL Lateral Lumbar Cage, Spineart (2016) Summary page 4.
- K141135: Juliet LL, Spineart (2014) Summary page 4.

## Most influential descendants
- K190877: Juliet® Ti LL Lumbar Interbody Device (2019), 1 descendant of its own
- K241321: Juliet® Ti LL Lumbar Interbody Device (2024), 0 descendants of its own

## 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). These spinal implants are to be used with autogenous bone graft. JULIET® Ti LL Lumbar Interbody Device is to be used with supplemental fixation. 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/K173702
Methodology: https://510kreport.com/methodology