Home / 510(k) Clearances / K243838

510(k) K243838

NEXXT MATRIXX® SI System by Nexxt Spine — Product Code OUR

K243838 is an FDA 510(k) premarket notification submitted by Nexxt Spine for the device "NEXXT MATRIXX® SI System". The FDA issued a decision of Substantially Equivalent on March 14, 2025. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040. Nexxt Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2025
Date Received
December 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sacroiliac Joint Fixation
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

sacroiliac joint fusion

Other clearances by Nexxt Spine

  • K240690 — STRUXXURE® MCS Anterior Cervical Plate System (March 22, 2024)
  • K231799 — INERTIA® CONNEXX™ Modular Pedicle Screw System (July 20, 2023)
  • K221905 — INERTIA CONNEXX Modular Pedicle Screw System (July 28, 2022)
  • K220291 — NEXXT SPINE NAVIGATION System (March 31, 2022)
  • K202230 — NEXXT MATRIXX Stand Alone ALIF System (December 15, 2020)
  • K202192 — STRUXXURE®-L and STRUXXURE®-A Plate System (September 17, 2020)
  • K200969 — NEXXT MATRIXX System (May 21, 2020)
  • K200543 — NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System (March 23, 2020)
  • K193412 — NEXXT MATRIXX System (February 24, 2020)
  • K193370 — Nexxt Matrixx System (January 21, 2020)

Other clearances for product code OUR

  • K261381 — TiLink-L™ SI Joint Fusion System (August 24, 2026)
  • K260477 — CATAMARAN™ SI Joint Fusion System (April 8, 2026)
  • K253488 — iFuse INTRA Ti™ Implant System (February 11, 2026)
  • K253611 — Falco Fusion System (January 29, 2026)
  • K252834 — Sacroiliac Joint Truss System (SJTS) (January 28, 2026)
  • K251365 — OptumSI Implant System (November 20, 2025)
  • K252322 — SIros-X System (October 22, 2025)
  • K253094 — iFuse Bedrock Granite Implant System (October 9, 2025)
  • K250894 — Eminent Spine Posterior SI System (October 7, 2025)
  • K250647 — SImmetry+ System (July 29, 2025)

FDA data resources