# K212962: TRELLIS™ SI Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Orthofundamentals, LLC
- Decided: Apr 11, 2022 after 207 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: 20 generations back to K040583 (2004). 614 ancestors in all.
No later device cites it as a predicate yet.
1 of 615 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203138: FIREBIRD SI Fusion System, Orthofix, Inc. (2020) Summary page 4.
- K101545: Genesis Implant System, Keystone Dental (2010) Summary page 4.
- K193524: SI-BONE iFuse Implant System®, SI-BONE, Inc. (2020) Summary page 4.
- K183119: SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments, Globus Medical, Inc. (2019) Summary page 4.
- K141549: SImmetry Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2015) Summary page 4.

## Cited in the summary but kept off the family tree
- K029132: 6.5mm Cannulated Screw. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 4.

## Indications for use
The OrthoFundamentals TRELLIS™ ST Joint Fusion and Stabilization Implant System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including: Sacroiliac joint disruptions Degenerative sacroiliitis To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.

Source page: https://510kreport.com/device/K212962
Methodology: https://510kreport.com/methodology