# K153621: Juliet® Ti

- Pathway: 510(k) (Traditional)
- Applicant: Spineart
- Decided: Jul 15, 2016 after 210 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 15 generations back to K841189 (1984). 135 ancestors in all.
75 later devices descend from it; 8 cite 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)
- K150481: Cascadia Interbody System, K2m, Inc. (2015) Summary page 4.
- K081888: Dynamik Intervertebral Body Fusion Device, Spineart (2009) Summary page 4.
- K142277: Juliet PO, Spineart (2014) Summary page 4.
- K120368: Capstone Control Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 4.
- K133650: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 4.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 4.

## Most influential descendants
- K181818: Scarlet AL-T (2018), 64 descendants of its own
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 descendants of its own
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own
- K214006: Invictus® Spinal Fixation System (2022), 16 descendants of its own

## Recalls of this device
- Feb 5, 2019 · Class III · Z-0546-2020: Inner blister pack label is incorrect and does not match the correct external box label.

## Indications for use
Juliet® Ti PO, OL & TL lumbar interbody devices are indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine 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 and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Juliet® Ti lumbar interbody devices are to be used with supplemental fixation that has been cleared for use in the lumbosacral spine. 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/K153621
Methodology: https://510kreport.com/methodology