# K231807: primaLOK™ SP Interspinous Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Wenzel Spine, Inc.
- Decided: Aug 15, 2023 after 56 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: 5 generations back to K032037 (2003). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213266: Inspan ScrewLES Fusion System, Lespine Innovations, LLC (2021) Summary page 4.
- K100354: Primal OK Interspinous Fusion System, Osteomed LP (2010) Summary page 4.

## Indications for use
The primalLOK™ SP Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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), tumor, and/or lumbar spinal stenosis. The primalLOK™ SP Interspinous Fusion System is intended for use with bone graft material and not intended for stand-alone use.

Source page: https://510kreport.com/device/K231807
Methodology: https://510kreport.com/methodology