Cleared Traditional

OSTEOMNI SPINAL FIXATION SYSTEM

K254247 · OSTEOMNI, Inc. · Orthopedic

Feb 2026

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K254247 is an FDA 510(k) clearance for the OSTEOMNI SPINAL FIXATION SYSTEM, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by OSTEOMNI, Inc. (Medley, US). The FDA issued a Cleared decision on February 24, 2026, 57 days after receiving the submission on December 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K254247 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2025
Decision Date	February 24, 2026
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.