Cleared Special

Freefix Forearm Plating System (K242055) - FDA 510(k) Clearance

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

K242055 · Skeletal Dynamics, Inc. · Orthopedic device
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Aug 2024
Decision
17d
Days
Class 2
Risk

K242055 is an FDA 510(k) clearance for the Freefix Forearm Plating 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 Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on August 1, 2024 after a review of 17 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 Skeletal Dynamics, Inc. devices

Submission Details

510(k) Number K242055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2024
Decision Date August 01, 2024
Days to Decision 17 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
105d faster than avg
Panel avg: 122d · This submission: 17d
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 K242055.
RibFix Titan™ Fixation System
K241282 · Riverpoint Medical · Aug 2024
NCB® Polyaxial Locking Plate System
K241754 · Zimmer Switzerland Manufacturing GmbH · Aug 2024
CoLink NeoFuse MIS Plating System (see attached parts list)
K241387 · In2bones USA · Aug 2024
Activmotion S
K241539 · Newclip Technics · Jul 2024
VOLT™ Proximal Humerus 3.5 Plating System
K233994 · Synthes GmbH · Jul 2024
Gaudi Proximal Humerus Plate
K241296 · Netbiologics, LLC · Jul 2024