# K133717: Longbow Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine
- Decided: Sep 19, 2014 after 288 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: 13 generations back to K841189 (1984). 95 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131077: Life Spine Plateau Spacer System, Life Spine (2013) Summary page 4.
- K123913: Latis Spacer, Globus Medical, Inc. (2013) Summary page 4.
- K090566: Pathway Avid, Custom Spine, Inc. (2009) Summary page 4.
- K073348: Lucent Magnum, Spinal Elements, Inc. (2007) Summary page 4.

## Most influential descendants
- K201721: TruLift Expandable Spacer System (2020), 5 descendants of its own
- K210061: ProLift Lateral HELO Fixated (2021), 3 descendants of its own
- K221806: TruLift Lateral Expandable Spacer System & Lateral Plate System (2022), 1 descendant of its own
- K170919: The TiBow Expandable Spacer System (2017), 1 descendant of its own
- K261430: TruLift Expandable System (2026), 0 descendants of its own

## Indications for use
The Longbow 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 autogenous bone graft 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/K133717
Methodology: https://510kreport.com/methodology