Cleared Traditional

K173910 - Impress SFS System

K173910 is the FDA 510(k) clearance for Impress SFS System by Cable Fix Medical, LLC. It is a Class 2 Orthopedic device (product code JDQ) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K173910 · Cable Fix Medical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Cable Fix Medical, LLC devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 122d · 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 Consultant

Msquared Associates, Inc.
Janet Akil

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 - JDQ Cerclage, Fixation

All 82
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K173910.
Sternal Cable System
K193479 · A & E Medical Corporation · Mar 2020
Tritium Sternal Cable Plate System
K193468 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Mar 2020
Thorecon Rigid Fixation System
K181607 · A & E Medical Corporation · Oct 2018
SuperCable® Iso-Elastic™ Cerclage System
K181749 · Kinamed, Incorporated · Aug 2018
DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional
K172975 · Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · Jun 2018
Sternal Cable System
K180582 · A & E Medical Corporation · May 2018