# K261309: Palisades™ Buttress Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Bethesda Medical Devices, LLC
- Decided: Jul 16, 2026 after 86 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K922543 (1993). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143065: NuVasive ALIF Buttress Plate System, Nu Vasive, Incorporated (2015) Summary page 5.

## Indications for use
The Palisades™ Buttress Plate System is a non-load bearing plate system that may be used in the thoracic, lumbar and sacral spine (T1-S1). The Palisades™ Buttress Plate System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts and autografts. This device is not intended for load bearing applications.

Source page: https://510kreport.com/device/K261309
Methodology: https://510kreport.com/methodology