Cleared Traditional

K151456 - Small Bone Nail Implant

K151456 is an FDA 510(k) clearance for Small Bone Nail Implant, manufactured by Vilex IN Tennessee, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K151456 · Vilex IN Tennessee, Inc. · Orthopedic device
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Oct 2015
Decision
150d
Days
Class 2
Risk

K151456 is an FDA 510(k) clearance for the Small Bone Nail Implant. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Vilex IN Tennessee, Inc. (Mcminnville, US). The FDA issued a Cleared decision on October 29, 2015 after a review of 150 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Vilex IN Tennessee, Inc. devices

FDA 510(k) Submission Details - K151456

510(k) Number K151456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2015
Decision Date October 29, 2015
Days to Decision 150 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
28d slower than avg
Panel avg: 122d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 Consultant

Vilex, Inc.
ABRAHAM LAVI

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.

Regulatory Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K151456.
Cardinal Health Trochanteric IM Nail System
K150769 · Cardinalhealth · Dec 2015
SIGN Hip Construct (SHC)
K152757 · Sign Fracture Care International · Nov 2015
Talon DistalFix Antegrade/Retrograde Femoral Nail
K152295 · Orthopedic Designs North America, Inc. · Nov 2015
GPC Intramedullary Nailing Systems
K143245 · Gpc Medical Limited · Sep 2015
Piccolo Composite Nailing System
K151010 · CarboFix Orthopedics , Ltd. · Jul 2015
The Simple Locking IntraMedullary (SLIM) System
K143355 · Pega Medical, Inc. · Jul 2015