# K200991: EVOL Spinal Interbody System

- Pathway: 510(k) (Special)
- Applicant: Cutting Edge Spine, LLC
- Decided: May 13, 2020 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: 20 generations back to K841189 (1984). 234 ancestors in all.
No later device cites it as a predicate yet.
0 of 235 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102957: Cutting Edge Spine Interbody Fusion Device, Cutting Edge Spine, LLC (2011) Summary page 5.
- K180891: EVOL Spinal Interbody System, EVOS Lumbar Interbody System, Cutting Edge Spine, LLC (2018) Summary page 5.
- K192497: EVOL ha - D Lateral Interbody Fusion System, Cutting Edge Spine, LLC (2020) Summary page 5.

## Indications for use
The EVOL® Spinal Interbody System is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The EVOL® Spinal Interbody System is intended to be used with autograft and/or allograft comprised of cancellous and/ or corticocancellous bone graft to facilitate fusion. It is to be used in patients who have had six months of non-operative treatment and is to be implanted via a direct posterior, transforaminal or anterior approach. The CES-LIF is implanted in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K200991
Methodology: https://510kreport.com/methodology