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Expedium Spine System

by Depuy Spine, A Johnson & Johnson Company 510(k)

Active United States

510(k) K102249

Overview

The Expedium Spine System is a thoracolumbar trauma system that offers single-screw tightening locking technology. It includes cobalt-chromium-molybdenum rods as part of its spinal fixation components.

The system is supplied as a medical device for use in spinal surgery procedures. It is authorized under FDA 510(k) clearance (K102249) with product code NKB and is classified as substantially equivalent to a predicate device. The system is manufactured by Depuy Spine, a Johnson & Johnson Company, and is intended for use in orthopedic spinal applications as indicated by its advisory committee classification.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK102249 Date16 Dec 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Depuy Spine, A Johnson & Johnson Company

Questions

  • What is the Expedium Spine System used for?

    The Expedium Spine System is a thoracolumbar trauma system designed for use in spinal surgery procedures, specifically for orthopedic spinal applications as indicated by its advisory committee classification.

  • How is the Expedium Spine System supplied and what materials does it include?

    The system is supplied as a medical device for spinal surgery and includes cobalt-chromium-molybdenum rods as part of its spinal fixation components, featuring single-screw tightening locking technology.

  • What regulatory pathway was used for the Expedium Spine System?

    The Expedium Spine System was authorized under FDA 510(k) clearance (K102249) and determined to be substantially equivalent to a predicate device, with product code NKB and special clearance type.