# K211496: TransLoc 3D

- Pathway: 510(k) (Traditional)
- Applicant: Foundation Fusion Solutions, LLC (Dba Cornerloc)
- Decided: Jul 27, 2022 after 440 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: 16 generations back to K841189 (1984). 137 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 145 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 5.
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), Tenon Medical, Inc. (2018) Summary page 5.
- K200696: FIREBIRD SI Fusion System, Orthofix, Inc. (2020) Summary page 5.

## Most influential descendants
- K231689: iFuse TORQ® Implant System (2023), 5 descendants of its own
- K241574: iFuse TORQ® Implant System (2024), 4 descendants of its own
- K243565: DYNAMIS™ SI Screw System (2025), 1 descendant of its own
- K253488: iFuse INTRA Ti™ Implant System (2026), 0 descendants of its own
- K251075: DYNAMIS™ Implant System (2025), 0 descendants of its own

## Indications for use
TransLoc 3D 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/K211496
Methodology: https://510kreport.com/methodology