Class Class II

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (K241813)

K241813 2024-08-13 Traditional
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Description

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System by Si-Technology, LLC, an FDA 510(k) cleared orthopedic device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241813
Clearance Date2024-08-13
Clearance TypeTraditional
Product CodeOUR
Regulation Number888.3040

Categories

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Predicate lineage for K241813

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (K241813) cites 5 predicate devices and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K231944CATAMARAN SI Joint Fusion SystemTenon Medical, Inc.2023
K190230iFuse Implant System®SI-BONE, Inc.2019
K180818Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixatio...Tenon Medical, Inc.2018
K151462SI-TECHNOLOGY® SI-DESIS® SCREWSSi-Technology, LLC2015
K021932SYNTHES 6.5 MM CANNULATED SCREWSynthes (Usa)2002

Later devices that cite this one as their predicate

Devices that cite K241813
K numberDeviceApplicantYear
K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC2025

Trace the full predicate network for K241813

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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