# K192497: EVOL ha - D Lateral Interbody Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Cutting Edge Spine, LLC
- Decided: Jan 6, 2020 after 117 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: 18 generations back to K841189 (1984). 203 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153782: NuVasive® Lumbar Interbody Implants, Nu Vasive, Incorporated (2016) Summary page 5.
- K180674: EVOL® ha-C Cervical Interbody Fusion System, Cutting Edge Spine, LLC (2018) Summary page 5.
- K102957: Cutting Edge Spine Interbody Fusion Device, Cutting Edge Spine, LLC (2011) Summary page 5.

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

## Indications for use
The EVOL® ha – D Lateral Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. EVOL® ha – D Lateral Interbody Fusion System is indicated for use at either one level or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The EVOL® ha – D Lateral Interbody Fusion System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental fixation system cleared by the FDA for use in the lumbosacral spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

Source page: https://510kreport.com/device/K192497
Methodology: https://510kreport.com/methodology