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Valkyrie Thoracic Fixation System

by Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices

510(k) K202889

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 · Traditional NumberK202889 Date2 Mar 2021ClearedStatusActive

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  • Withdrawn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)

Full name
Able Medical Devices Valkyrie Thoracic Fixation System
510(k) Number
FDA Product Code
HRS
FDA applicant
Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Valkyrie Thoracic Fixation System is a spinal orthopedic device classified as a Thoracic Fixation Device under the FDA’s orthopedic nomenclature. It is designed to provide internal fixation for the thoracic spine, stabilizing vertebrae through surgical implantation of screws, rods, and connectors to promote proper alignment and fusion during spinal reconstruction or correction procedures.

This system is intended for surgical use in controlled hospital or clinical settings and is supplied sterile for single-use. The device is regulated under the FDA’s 510(k) clearance process, with a traditional review pathway under the Orthopedic (OR) advisory committee. It adheres to 21 CFR Part 820 quality systems requirements and is distributed with model-specific components for precise thoracic fixation, ensuring compliance with medical device manufacturing standards.

Other devices from Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices

Questions

AI-generated answers, 19 Sep 2026

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

  • What types of spinal procedures is the Valkyrie Thoracic Fixation System intended for, and how does it stabilize the thoracic spine?

    The Valkyrie Thoracic Fixation System is designed for surgical use in stabilizing the thoracic spine during procedures like spinal reconstruction or correction. It achieves this through the implantation of screws, rods, and connectors, which work together to promote proper vertebral alignment and facilitate spinal fusion. This internal fixation helps maintain stability in the thoracic region, supporting recovery and structural integrity post-surgery.

  • Is the Valkyrie Thoracic Fixation System intended for reuse, or is it meant to be used only once?

    The Valkyrie Thoracic Fixation System is supplied sterile and explicitly intended for single-use only. This ensures patient safety and compliance with medical device standards, as reuse could compromise sterility and device integrity.

  • How is the Valkyrie Thoracic Fixation System regulated by the FDA, and what does that mean for clinicians?

    The Valkyrie System is regulated under the FDA’s 510(k) clearance process, specifically through a traditional review with the Orthopedic (OR) advisory committee. This means it was evaluated for substantial equivalence to a predicate device and meets 21 CFR Part 820 quality systems requirements. Clinicians can rely on its compliance with FDA standards, ensuring safety and performance for thoracic spine fixation procedures.

  • What components does the Valkyrie Thoracic Fixation System include, and are they interchangeable across models?

    The Valkyrie System is distributed with model-specific components—including screws, rods, and connectors—tailored for precise thoracic fixation. While the design allows for modular assembly, the components are not universally interchangeable across all models; compatibility must be verified per the manufacturer’s instructions to ensure proper function and safety during surgery.

  • How should the Valkyrie Thoracic Fixation System be stored, and what precautions should be taken?

    Since the system is supplied sterile for single-use, it must be stored in its original, unopened packaging to maintain sterility. Storage should follow the manufacturer’s guidelines, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination or exposure to moisture, as this could compromise the device’s integrity before use.