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510(k) K253721

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2025
Date Received
November 24, 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

  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • 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

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)
  • K252730 — Fule Spinal Fixation System (October 24, 2025)