# K232877: FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System

- Pathway: 510(k) (Traditional)
- Applicant: K&J Consulting Corporation
- Decided: Dec 13, 2023 after 89 days
- Product code: MRW (System, Facet Screw Spinal Device)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K841189 (1984). 374 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 376 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222515: FaSet Fixation System, Dio Medical Corporation (2022) Summary page 10.
- K222448: UNITY Sacroiliac Joint Fixation System, Dio Medical Corporation (2022) Summary page 10.
- K223790: Huvex Interspinous Fusion System, Dio Medical Corp. (2023) Summary page 10.
- K223140: AEON-C™ Stand Alone System, Dio Medical, Inc. (2022) Summary page 10.
- (no number) Dio Medical - FaSet Fixation System: named in the summary without a submission number
- (no number) Dio Medical - Huvex Interspinous Fixation System: named in the summary without a submission number
- (no number) Dio Medical - AEON-C Stand Alone System: named in the summary without a submission number

## Most influential descendants
- K250335: IVA & AEON Cervical and Lumbar Cage System (2025), 0 descendants of its own

## Indications for use
The FaSet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of facet joints. The Facet Screw System is indicated for posterior surgical treatment with or without bone graft at single or multiple levels from C2 to S1 (inclusive). For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The FaSet Fixation System is indicated for treatment for any or all of the following: - Spondylolisthesis - Pseudoarthrosis or failed previous fusions which are symptomatic, or which may cause secondary instability or deformity - Spondylolysis - Degenerative Disk Disease (DDD) as defined by back pain of discogenic origin with degeneration of disk confirmed by history and radiographic studies and/or degenerative disease of the facets with instability - Trauma including spinal fractures and/or dislocations. The UNITY Sacroiliac Joint Fixation System is indicated for sacroiliac joint fusion for: - Sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint disruptions - Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion The UNITY Sacroiliac Joint Fixation System is also indicated for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. The Huvex Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the spinous processes 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 Huvex Interspinous Fixation System is intended for use, in conjunction with autogenous bone graft, and not intended for stand-alone use. The AEON-C™ Stand Alone System is a stand-alone anterior cervical intervertebral fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The AEON-C™ Stand Alone System should be packed with autograft and/or allograft comprised of cancellous, cortical and/or corticocancellous bone graft and implanted with an anterior approach. Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with a cervical intervertebral fusion device. If the device is being used without the provided screws, supplemental fixation must be used.

Source page: https://510kreport.com/device/K232877
Methodology: https://510kreport.com/methodology