# K180891: EVOL Spinal Interbody System, EVOS Lumbar Interbody System

- Pathway: 510(k) (Special)
- Applicant: Cutting Edge Spine, LLC
- Decided: May 4, 2018 after 29 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: 19 generations back to K841189 (1984). 156 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 158 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 6.
- K150321: EVOS Lumbar Interbody System, Cutting Edge Spine, LLC (2015) Summary page 6.
- K170395: Talos® Lumbar (HA) PEEK IBF Devices, Meditech Spine, LLC (2017) Summary page 6.

## Most influential descendants
- K200991: EVOL Spinal Interbody System (2020), 0 descendants of its own

## 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, retroperitoneal or anterior approach. The CES‐ PLIF and CES‐LIF are implanted in pairs, while the CES‐TLIF, CES‐CLIF and CES‐RLIF devices may be implanted singly or in pairs in the lumbosacral spine. The EVOL® Spinal Interbody System is intended to be used with supplemental fixation. The EVOS Lumbar 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 EVOS Lumbar 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 or transforaminal approach. The EVOS CURVED devices are implanted singly, while the EVOS ROTATE and EVOS STRAIGHT devices may be implanted singly or in pairs in the lumbosacral spine. The EVOS Lumbar Interbody System is intended to be used with supplemental fixation.

Source page: https://510kreport.com/device/K180891
Methodology: https://510kreport.com/methodology