# K180519: HARRIER-SA™ Lumbar Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Choicespine, LP
- Decided: May 16, 2018 after 78 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 21 generations back to K841189 (1984). 285 ancestors in all.
No later device cites it as a predicate yet.
1 of 286 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102090: Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System, Spine Smith Partners L.P. (2010) Summary page 5.
- K153782: NuVasive® Lumbar Interbody Implants, Nu Vasive, Incorporated (2016) Summary page 5.
- K170953: Tomcat Cervical Spinal System, Choicespine, LP (2017) Summary page 5.
- K172816: TiGer Shark™ System, Choicespine, LP (2018) Summary page 5.

## Indications for use
The Choice Spine HARRIER-SA™ Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of nonoperative treatment. This device is intended for use at either one level or two contiguous levels 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. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws and the accompanying anterior cover plate. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used. The anterior cover plate must be utilized whenever the device is implanted.

Source page: https://510kreport.com/device/K180519
Methodology: https://510kreport.com/methodology