Cleared Traditional

K173910 - Impress SFS System (FDA 510(k) Clearance)

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

K173910 · Cable Fix Medical, LLC · Orthopedic device
Sep 2018
Decision
266d
Days
Class 2
Risk

K173910 is an FDA 510(k) clearance for the Impress SFS System. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Cable Fix Medical, LLC (Hernando, US). The FDA issued a Cleared decision on September 14, 2018 after a review of 266 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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.

Submission Details

510(k) Number K173910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2017
Decision Date September 14, 2018
Days to Decision 266 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 116d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K173910.
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