Cleared Traditional

K161327 - SYNTEC HUMERAL NAIL SYSTEM

K161327 is an FDA 510(k) clearance for SYNTEC HUMERAL 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 392-day FDA review.

K161327 · Syntec Scientific Corporation · Orthopedic device
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Jun 2017
Decision
392d
Days
Class 2
Risk

K161327 is an FDA 510(k) clearance for the SYNTEC HUMERAL 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 June 8, 2017 after a review of 392 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 - K161327

510(k) Number K161327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2016
Decision Date June 08, 2017
Days to Decision 392 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
270d slower than avg
Panel avg: 122d · This submission: 392d
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 Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 366
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K161327.
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