Cleared Traditional

K153208 - Internal Joint Stabilizer - Elbow

K153208 is an FDA 510(k) clearance for Internal Joint Stabilizer - Elbow, manufactured by Skeletal Dynamics, LLC. The device is a Class 2 Orthopedic device with product code OZI cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K153208 · Skeletal Dynamics, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Skeletal Dynamics, LLC devices

FDA 510(k) Submission Details - K153208

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

OZI Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
John J Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT01944670 Completed Interventional Industry-sponsored

Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow

Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow ("IJS-E")

26
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Trauma; Chronic Elbow Dislocation
Study design Single group
Eligibility All sexes · 21 Years+ · Healthy volunteers accepted
Principal investigator David Ring, MD
Sponsor Skeletal Dynamics, LLC (industry)
Started 2013-08-01 → Primary completion 2015-06-01 → Completed 2015-09-01
Primary outcome
Broberg Morrey Functional Rating
View full study on ClinicalTrials.gov