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Mantis Spinal System & Mantis Redux Spinal System

by Stryker Spine

510(k) K102235

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK102235 Date24 Aug 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mantis Spinal System & Mantis Redux Spinal System is a percutaneous pedicle screw system featuring standard and reduction cannulated screws for less invasive fixation of the thoracolumbar spine. It is designed for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation and incorporates components from the Stryker Spine Radius Spinal System, including Ø5.5mm titanium and Vitallium rods.

The system is supplied as a sterile, single-use device intended for use in surgical settings. It has received FDA 510(k) clearance under K102235 with product code NKB and is manufactured by Stryker Spine.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Mantis Spinal System used for?

    The Mantis Spinal System is designed for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the thoracolumbar spine, providing less invasive stabilization using standard and reduction cannulated screws.

  • How is the Mantis Spinal System supplied and is it reusable?

    The system is supplied as a sterile, single-use device intended for use in surgical settings, meaning each component is designed for one procedure only and must not be reprocessed or reused.

  • What components are included in the Mantis Spinal System?

    The system incorporates components from the Stryker Spine Radius Spinal System, including Ø5.5mm titanium and Vitallium rods, along with standard and reduction cannulated percutaneous pedicle screws for thoracolumbar fixation.