# K232484: KeyLift™ Expandable Interlaminar Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Flospine
- Decided: Oct 19, 2023 after 64 days
- Product code: PEK (Spinous Process Plate)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K990745 (1999). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153302: coflex-IF, Paradigm Spine, LLC (2016) Summary page 4.
- K130438: Axle Interspinous Fusion System, X-Spine Systems, Inc. (2013) Summary page 4.

## Indications for use
The FloSpine KeyLift™ Expandable Interlaminar Stabilization System is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes/lamina for the purpose of achieving supplemental fusion in the following conditions: Lumbar spinal stenosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The KeyLift™ Expandable Interlaminar Stabilization System is intended for use with allograft or autograft bone and is not intended for stand-alone use.

Source page: https://510kreport.com/device/K232484
Methodology: https://510kreport.com/methodology