# K193174: Keos Lumbar IBFD

- Pathway: 510(k) (Special)
- Applicant: Keos
- Decided: Dec 16, 2019 after 28 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: 14 generations back to K841189 (1984). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160631: Keos Lumbar IBFD, Keos (2016) Summary page 4.
- K163386: Keos Lumbar IBFD, Keos (2017) Summary page 4.

## Indications for use
The Keos Lumbar IBFD is indicated for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) of the spine. 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 I 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 provide support to the spine for a posterior surgery.

Source page: https://510kreport.com/device/K193174
Methodology: https://510kreport.com/methodology