# K101720: Juliet OL

- Pathway: 510(k) (Special)
- Applicant: Spineart
- Decided: Jul 16, 2010 after 28 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: 4 generations back to K010530 (2001). 8 ancestors in all.
259 later devices descend from it; 8 cite it directly.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081888: Dynamik Intervertebral Body Fusion Device, Spineart (2009) Summary page 1.

## Most influential descendants
- K133557: Juliet LL Lateral Lumbar Cage (2014), 147 descendants of its own
- K141135: Juliet LL (2014), 146 descendants of its own
- K161888: JULIET® LL Lateral Lumbar Cage (2016), 145 descendants of its own
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF (2018), 141 descendants of its own
- K201605: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage (2020), 130 descendants of its own

## Indications for use
JULIET® OL 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 spondylolistesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. JULIET® OL 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/K101720
Methodology: https://510kreport.com/methodology