# K213266: Inspan ScrewLES Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Lespine Innovations, LLC
- Decided: Dec 3, 2021 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: 4 generations back to K032037 (2003). 9 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102020: Vega Span Spinous Process Plate System, Spinefrontier, Inc. (2010) Summary page 4.

## Most influential descendants
- K232605: Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System (2023), 0 descendants of its own
- K231807: primaLOK™ SP Interspinous Fusion System (2023), 0 descendants of its own
- K221399: ZIP™ MIS Interspinous Fusion System (2022), 0 descendants of its own

## Indications for use
The Inspan ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.

Source page: https://510kreport.com/device/K213266
Methodology: https://510kreport.com/methodology