Cleared Traditional

K153208 - Internal Joint Stabilizer - Elbow (FDA 510(k) Clearance)

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

K153208 · Skeletal Dynamics, LLC · Orthopedic device
Dec 2015
Decision
56d
Days
Class 2
Risk

K153208 is an FDA 510(k) clearance for the Internal Joint Stabilizer - Elbow. Classified as Internal Hinged Elbow Fixator (product code OZI), Class II - Special Controls.

Submitted by Skeletal Dynamics, LLC (Miami, US). The FDA issued a Cleared decision on December 31, 2015 after a review of 56 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.

Submission Details

510(k) Number K153208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2015
Decision Date December 31, 2015
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 116d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OZI Internal Hinged Elbow Fixator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
Definition The Hinged Internal Fixator Is Intended To Treat Joint Dislocations, More Specifically Of The Elbow Joint. The Device Is Intended To Be Removed Once Stability Is Achieved.
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.