# K152237: The Entasis Dual-Lead Sacroiliac Implant

- Pathway: 510(k) (Traditional)
- Applicant: Corelink, LLC
- Decided: Feb 4, 2016 after 178 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: 8 generations back to K903810 (1990). 27 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 39 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.
- K140079: Silex Sacroiliac Joint Fusion System, X-Spine Systems, Inc. (2014) Summary page 5.

## Most influential descendants
- K223708: Entasis 3D Dual-Lead Sacroiliac Implant System (2023), 3 descendants of its own
- K223521: ZESPIN SI Joint Fusion System (2023), 2 descendants of its own
- K240505: Eminent Spine SI Screw System (2024), 1 descendant of its own
- K231841: PathLoc SI Joint Fusion System (2023), 1 descendant of its own
- K213590: Blue Topaz Sacroiliac Screw System (2022), 1 descendant of its own

## Indications for use
The Entasis™ Dual-Lead Sacroiliac Implant system is intended for sacroiliac joint fusion for conditions including degenerative sacroilitis and sacroiliac joint disruptions.

Source page: https://510kreport.com/device/K152237
Methodology: https://510kreport.com/methodology