Cleared Special

Hand Trauma Threaded Nail System (K230908) - FDA 510(k) Clearance

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

K230908 · Skeletal Dynamics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
28d
Days
Class 2
Risk

K230908 is an FDA 510(k) clearance for the Hand Trauma Threaded Nail System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Skeletal Dynamics, Inc. (Miami, US). The FDA issued a Cleared decision on April 28, 2023 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 K230908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2023
Decision Date April 28, 2023
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K230908.
Bone Bolt System
K230867 · University of Utah, Department of Orthopaedics · Jun 2023
Cut Screw - Percutaneous Compression Screw
K230397 · GM Dos Reis Industria e Comercio Ltda. · Jun 2023
Acumed Acutrak 3 Headless Compression Screw System
K230744 · Acumed, LLC · Jun 2023
SimpliFix Hip System
K230053 · Stabiliz Orthopaedics, Inc. · Apr 2023
TriMed Threaded Intramedullary Nail System
K230749 · TriMed, Inc. · Apr 2023
REVCON (TM) Screw System
K223392 · Voom Medical Devices, Inc. · Feb 2023