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510(k) K253990

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

K253990 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 January 7, 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
January 7, 2026
Date Received
December 12, 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

  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (September 4, 2026)
  • K261500 — KBA3D (v2.4.0) (August 17, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K260786 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (April 3, 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)

Other clearances for product code NKB

  • K262091 — FRAXION Spinal Fixation System (September 17, 2026)
  • K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor (September 14, 2026)
  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (September 4, 2026)
  • K253943 — Tiger 2 System (July 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Co (July 24, 2026)
  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 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)

FDA data resources