# K180071: STYLO Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Legend Spine Technologies
- Decided: May 3, 2018 after 114 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: 17 generations back to K003155 (2001). 175 ancestors in all.
No later device cites it as a predicate yet.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171107: CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 5.
- K133650: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2013) Summary page 5.
- K121254: Camber Spine Technologies TLS 5.0 Inerbody Cage, Camber Spine Technologies (2013) Summary page 5.

## Indications for use
The LEGEND Spine STYLO Interbody Fusion Device is 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 pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). LEGEND Spine STYLO Interbody Fusion Device is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. LEGEND Spine STYLO Interbody Fusion Device implants are 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/K180071
Methodology: https://510kreport.com/methodology