Cleared Traditional

K163486 - DRACO Locking Bone Screws

Also marketed or referenced as:
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

K163486 is an FDA 510(k) clearance for DRACO Locking Bone Screws, manufactured by Hnm Total Recon, LLC. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K163486 · Hnm Total Recon, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K163486

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
Combination Product No
PCCP Authorized No
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.

KTT Device Classification - Class 2, Special Controls

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 Consultant

D2d Development, LLC
Craig Pagan

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

All 394
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K163486.
Spider Frame External Fixation System
K170482 · Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S · Sep 2017
OIC External Fixation System
K171211 · Orthopaedic Implant Company · Sep 2017
The Locking Pediatric Osteotomy Plate (LolliPOP) System
K170704 · Pega Medical, Inc. · Sep 2017
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
K170650 · Orthofix Srl · May 2017
Hoffmann LRF System
K163656 · Stryker GmbH · Apr 2017
Dolphix® External Fixation System MR Conditional
K163323 · Citieffe S.R.L. · Mar 2017
K163486 · DRACO Locking Bone Screws
Download PDF Hnm Total Recon, LLC