Cleared Special

Valkyrie Thoracic Fixation System (K211695) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K211695 · Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices · Orthopedic device
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Jun 2021
Decision
21d
Days
Class 2
Risk

K211695 is an FDA 510(k) clearance for the Valkyrie Thoracic Fixation System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices (Gwinn, US). The FDA issued a Cleared decision on June 23, 2021 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices devices

Submission Details

510(k) Number K211695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2021
Decision Date June 23, 2021
Days to Decision 21 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K211695.
Acumed Clavicle Hook Plating System
K210750 · Acumed, LLC · Jul 2021
TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
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Smith & Nephew Plates and Screws
K210837 · Smith & Nephew, Inc. · Jun 2021
DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
K211051 · DePuy Synthes · Jun 2021
DRPx Locking Distal Radius Plate System
K202971 · Orthopaedic Implant Company · May 2021
JACE Medical Thoracic Plating System
K210290 · Jace Medical, LLC · Apr 2021