# K232605: Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System

- Pathway: 510(k) (Special)
- Applicant: Lesspine Innovations
- Decided: Sep 28, 2023 after 31 days
- Product code: OUR (Sacroiliac Joint Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K930834 (1993). 329 ancestors in all.
No later device cites it as a predicate yet.
0 of 330 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150017: SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System, Spinefrontier, Inc. (2015) Summary page 8.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 8.
- K223708: Entasis 3D Dual-Lead Sacroiliac Implant System, Corelink, LLC (2023) Summary page 8.
- K213266: Inspan ScrewLES Fusion System, Lespine Innovations, LLC (2021) Summary page 8.
- K121060: Spine Frontier Indus Acp System, Spinefrontier, Inc. (2012) Summary page 8.
- K093776: Indus Anterior Cervical Plate System, Spinefrontier, Inc. (2010) Summary page 8.
- K163104: Terrace™ Anterior Cervical Plate System, Corelink, LLC (2017) Summary page 8.
- K071420: Chameleon Fixation System, Spinefrontier, Inc. (2008) Summary page 8.
- K211855: Ion Facet Screw System, SurGenTec, LLC (2022) Summary page 8.
- K131471: Self-Compressive Screw, Neosteo (2013) Summary page 8.
- K012773: Discovery Facet Screw Fixation System, Depuyacromed (2001) Summary page 8.

## Indications for use
The Sacrix® Sacroiliac Joint Fusion Device System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. 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, or 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. The Invue® MAX™ + Invue Inset Anterior Cervical Plate System is intended for anterior spine fixation for use in providing temporary stabilization during the development of cervical spinal fusions. The levels of treatment range from C2 to T1. Indications include symptomatic cervical spondylolisthesis, trauma; (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and or lordosis), tumor, pseudloarthrosis, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), and re-operation for failed fusion or instability following surgery for above indications. The FacetFuse® Screw Fixation System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The subject device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels including: 1) Trauma, including spinal fractures and/ or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm.

Source page: https://510kreport.com/device/K232605
Methodology: https://510kreport.com/methodology