# K160631: Keos Lumbar IBFD

- Pathway: 510(k) (Traditional)
- Applicant: Keos
- Decided: Jul 15, 2016 after 130 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). 65 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080281: Pathway, Custom Spine, Inc. (2008) Summary page 4.
- K150321: EVOS Lumbar Interbody System, Cutting Edge Spine, LLC (2015) Summary page 4.

## Most influential descendants
- K193174: Keos Lumbar IBFD (2019), 0 descendants of its own

## Indications for use
Keos Lumbar IBFD is indicated for spinal fusion procedure at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The Keos Lumbar IBFD is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e., posterior pedicle screws and rod systems, anterior plate systems, and anterior screw and rod systems). The device(s) is intended to be used with autogenous bone graft. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. The Keos Lumbar IBFD can be used in one of two methods: Transforaminal Lumbar Interbody Fusion (TLIF) Used as a TLIF, a single device is implanted in the appropriate location (L2-S1) to provide support for a transforaminal approached surgery. Posterior Lumbar Interbody Fusion (PLIF) Used as a PLIF, two devices are implanted in the appropriate locations (L2-S1) to provided support to the spine for a posterior surgery.

Source page: https://510kreport.com/device/K160631
Methodology: https://510kreport.com/methodology