# K223708: Entasis 3D Dual-Lead Sacroiliac Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Mar 21, 2023 after 99 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: 21 generations back to K930834 (1993). 220 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 224 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212903: SIMPACT Sacroiliac Joint Fixation System, Life Spine, Inc. (2021) Summary page 5.
- K222605: iFuse TORQ® Implant System, SI-BONE, Inc. (2022) Summary page 5.
- K152237: The Entasis Dual-Lead Sacroiliac Implant, Corelink, LLC (2016) Summary page 5.
- K220195: iFuse Bedrock Granite™ Implant System, SI-BONE, Inc. (2022) Summary page 5.

## Most influential descendants
- K240505: Eminent Spine SI Screw System (2024), 1 descendant of its own
- K250894: Eminent Spine Posterior SI System (2025), 0 descendants of its own
- K232605: Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System (2023), 0 descendants of its own

## Indications for use
The Entasis 3D Dual-Lead Sacroiliac Implant System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions, 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. This includes those whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

Source page: https://510kreport.com/device/K223708
Methodology: https://510kreport.com/methodology