Xenix Medical Sacroiliac Fixation System

FDA 510(k) K231829 · Ht Medical D.B.A. Xenix Medical

Substantially Equivalent

510(k) numberK231829

Submission

Device name
Xenix Medical Sacroiliac Fixation System
Applicant
Ht Medical D.B.A. Xenix Medical
Orlando, FL, US
Received
June 21, 2023
Decision date
August 15, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OUR – Sacroiliac Joint Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

sacroiliac joint fusion

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K253488iFuse INTRA Ti™ Implant SystemOUR · Traditional SI-BONE, Inc.02/11/2026SE
K253611Falco Fusion SystemOUR · Traditional Mcnicoll Surgical, Inc.01/29/2026SE
K252834Sacroiliac Joint Truss System (SJTS)OUR · Traditional 4Web Medical01/28/2026SE
K251365OptumSI Implant SystemOUR · Traditional Si Solutions, LLC11/20/2025SE
K252322SIros-X SystemOUR · Traditional Genesys Spine10/22/2025SE
K253094iFuse Bedrock Granite Implant SystemOUR · Special SI-BONE, Inc.10/09/2025SE
K250894Eminent Spine Posterior SI SystemOUR · Traditional Eminent Spine10/07/2025SE
K250647SImmetry+ SystemOUR · Traditional Sivantage07/29/2025SE

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Questions and answers

When was Xenix Medical Sacroiliac Fixation System cleared by the FDA?

Xenix Medical Sacroiliac Fixation System (K231829) received a 510(k) decision of Substantially Equivalent on August 15, 2023, 55 days after the submission was received.

What is the product code of K231829?

The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.