# K133557: Juliet LL Lateral Lumbar Cage

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Feb 3, 2014 after 76 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). 82 ancestors in all.
147 later devices descend from it; 1 cites it directly.
0 of 230 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.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.
- K081611: Nuvasive Coroent System, Nuvasive, Inc. (2008) Summary page 1.
- K121760: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 1.
- K103666: Lanx Lateral, Lanx, Inc. (2011) Summary page 1.
- K090816: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 1.

## Most influential descendants
- 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
- K211258: Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System (2021), 75 descendants of its own

## Indications for use
JULIET® 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). This device is to be used with autogenous bone graft. JULIET® 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/K133557
Methodology: https://510kreport.com/methodology