Cleared Traditional

K163486 - DRACO Locking Bone Screws (FDA 510(k) Clearance)

Also includes:
DRACO Compression Screws DRACO MetaFuse L Plates DRACO MetaFuse BLP Plates DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates

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

K163486 · Hnm Total Recon, LLC · Orthopedic device
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Jul 2017
Decision
224d
Days
Class 2
Risk

K163486 is an FDA 510(k) clearance for the DRACO Locking Bone Screws. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Hnm Total Recon, LLC (Miami, US). The FDA issued a Cleared decision on July 24, 2017 after a review of 224 days - an extended review 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: 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 Hnm Total Recon, LLC devices

Submission Details

510(k) Number K163486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date July 24, 2017
Days to Decision 224 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 122d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

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