# K150321: EVOS Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Cutting Edge Spine, LLC
- Decided: Jul 13, 2015 after 154 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: 12 generations back to K841189 (1984). 60 ancestors in all.
92 later devices descend from it; 9 cite it directly.
0 of 153 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 4.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 4.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 4.
- K120368: Capstone Control Spinal System, Medtronic Sofamor Danek USA, Inc. (2012) Summary page 4.

## Most influential descendants
- K153615: NeoFuse HA Enhanced PLIF/TLIF (2016), 50 descendants of its own
- K170318: NeoFuse Ti3D PLIF/TLIF/Cervical Interbody (2017), 49 descendants of its own
- K192115: SABLE Expandable Spacer (2020), 37 descendants of its own
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own
- K172947: HALF DOME Posterior Lumbar Interbody System (2018), 22 descendants of its own

## Indications for use
The EVOS Lumbar Interbody System (EVOS device) 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 autologous 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/K150321
Methodology: https://510kreport.com/methodology