# K232878: TransLoc 3D

- Pathway: 510(k) (Special)
- Applicant: Foundation Fusion Solutions, LLC (Dba Cornerloc)
- Decided: Oct 17, 2023 after 29 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: 17 generations back to K841189 (1984). 138 ancestors in all.
No later device cites it as a predicate yet.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211496: TransLoc 3D, Foundation Fusion Solutions, LLC (Dba Cornerloc) (2022) Summary page 5.

## Indications for use
The TransLoc 3D Screw is intended for sacroiliac joint fusion for conditions including: • Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. • To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. • Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. The TransLoc 3D Posterior Implant is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. When the TransLoc 3D Posterior Implant is implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.

Source page: https://510kreport.com/device/K232878
Methodology: https://510kreport.com/methodology