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510(k) K253802

KHEIRON® Spinal Fixation System, including patient specific K-ROD by S.M.A.I.O — Product Code NKB

K253802 is an FDA 510(k) premarket notification submitted by S.M.A.I.O for the device "KHEIRON® Spinal Fixation System, including patient specific K-ROD". The FDA issued a decision of Substantially Equivalent on July 1, 2026. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. S.M.A.I.O has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2026
Date Received
November 28, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by S.M.A.I.O

  • K260786 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (April 3, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K251804 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 8, 2025)
  • K232650 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (September 29, 2023)
  • K223841 — KBA3D (May 30, 2023)
  • K211981 — KHEIRON® Spinal Fixation System (June 9, 2022)
  • K213975 — KEOPS Balance Analyzer 3D (May 6, 2022)
  • K211414 — KHEIRON Spinal Fixation System (August 10, 2021)
  • K201659 — KHEIRON® Spinal Fixation System (October 5, 2020)

Other clearances for product code NKB

  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)
  • K253739 — SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® (May 7, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)
  • K260216 — CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal System (April 21, 2026)

FDA data resources