# K191367: Harrier-SA Lumbar Interbody System

- Pathway: 510(k) (Special)
- Applicant: Choice Spine, LLC
- Decided: Jul 5, 2019 after 44 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites 2 numbers, none of which could be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K180519: HARRIER-SA™ Lumbar Interbody System, Choicespine, LP (2018). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K163269: Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic Interbody Fusion Device, Titan Spine, LLC (2017). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The ChoiceSpine 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 non-operative 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 ChoiceSpine Harrier-SA™ Lumbar Interbody System is a stand-alone device intended to be used with four bone screws. 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.

Source page: https://510kreport.com/device/K191367
Methodology: https://510kreport.com/methodology