Cleared Traditional

Syntec Tibial Nail System (K191617) - FDA 510(k) Clearance

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

K191617 · Syntec Scientific Corporation · Orthopedic device
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Sep 2019
Decision
77d
Days
Class 2
Risk

K191617 is an FDA 510(k) clearance for the Syntec Tibial 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 September 3, 2019 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Syntec Scientific Corporation devices

Submission Details

510(k) Number K191617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2019
Decision Date September 03, 2019
Days to Decision 77 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
45d faster than avg
Panel avg: 122d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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
Kavin Chu

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 262
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K191617.
Pediatric Nailing PlatformFemur
K190321 · OrthoPediatrics Corp. · Oct 2019
PRECICE System
K191336 · Nuvasive Specialized Orthopedics, Inc. · Sep 2019
TTC Phantom Intramedullary Nail System
K191782 · Paragon 28, Inc. · Sep 2019
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