# K190721: LongBow Ti

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Nov 14, 2019 after 239 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: 15 generations back to K841189 (1984). 99 ancestors in all.
No later device cites it as a predicate yet.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133717: Longbow Spacer System, Life Spine (2014) Summary page 4.
- K170919: The TiBow Expandable Spacer System, Life Spine, Inc. (2017) Summary page 4.

## Indications for use
The Longbow Ti Expandable Lateral Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

Source page: https://510kreport.com/device/K190721
Methodology: https://510kreport.com/methodology