# K140474: Juliet OL

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Apr 18, 2014 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: 13 generations back to K841189 (1984). 70 ancestors in all.
120 later devices descend from it; 1 cites it directly.
0 of 191 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.
- K101720: Juliet OL, Spineart (2010) Summary page 1.
- K121760: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 1.
- K120368: Capstone Control Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 1.
- K090816: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 1.

## Most influential descendants
- K142277: Juliet PO (2014), 119 descendants of its own
- K153621: Juliet® Ti (2016), 75 descendants of its own
- K181818: Scarlet AL-T (2018), 64 descendants of its own
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 descendants of its own
- K172816: TiGer Shark™ System (2018), 59 descendants of its own

## Indications for use
JULIET® 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). This device is to be used with autogenous bone graft. JULIET® 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/K140474
Methodology: https://510kreport.com/methodology