Cleared Traditional

K181296 - Syntec Femoral Nail System

K181296 is an FDA 510(k) clearance for Syntec Femoral Nail System, manufactured by Syntec Scientific Corporation. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K181296 · Syntec Scientific Corporation · Orthopedic device
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Apr 2019
Decision
330d
Days
Class 2
Risk

K181296 is an FDA 510(k) clearance for the Syntec Femoral Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Syntec Scientific Corporation (Chang Hua, TW). The FDA issued a Cleared decision on April 11, 2019 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Syntec Scientific Corporation devices

FDA 510(k) Submission Details - K181296

510(k) Number K181296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2018
Decision Date April 11, 2019
Days to Decision 330 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
208d slower than avg
Panel avg: 122d · This submission: 330d
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

Syntec Scientific Corporation - Taipei Office
Nicole Tseng

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 365
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K181296.
AOS ES Retrograde Femoral Nail
K191598 · Advanced Orthopaedic Solutions, Inc. · Jul 2019
Zimmer Guide Wire Devices
K191238 · Zimmer, Inc. · Jul 2019
T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
K191271 · Stryker Trauma GmbH · Jun 2019
PRECICE® BONE TRANSPORT™ System
K182170 · Nuvasive Specialized Orthopedics, Inc. · Feb 2019
Estremo Citieffe Nailing System
K181540 · Citieffe S.R.L. · Jan 2019
Small Bone Phantom® Intramedullary Nail System
K182307 · Paragon 28, Inc. · Jan 2019