Cleared Traditional

Distal Elbow Plating System (K231623) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231623 · Skeletal Dynamics, Inc. · Orthopedic device
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Aug 2023
Decision
87d
Days
Class 2
Risk

K231623 is an FDA 510(k) clearance for the Distal Elbow 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 28, 2023 after a review of 87 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Skeletal Dynamics, Inc. devices

Submission Details

510(k) Number K231623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2023
Decision Date August 28, 2023
Days to Decision 87 days
Submission Type Traditional
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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K231623.
Exactech Equinoxe PHx Fracture System
K223933 · Exactech, Inc. · Sep 2023
KITE Distal Fibula Kit
K230623 · Intrauma S.P.A · Sep 2023
TriMed Clavicle Fixation System
K230805 · TriMed, Inc. · Sep 2023
APS Metal Plate & Screw System
K223150 · A Plus Biotechnology Co., Ltd. · Aug 2023
Pangea Utility Plating System, Pangea Platform
K231257 · Stryker GmbH · Aug 2023
Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System
K231262 · Stryker GmbH · Aug 2023