Cleared Traditional

K041393 - FASSIER-DUVAL TELSCOPIC IM SYSTEM

K041393 is an FDA 510(k) clearance for FASSIER-DUVAL TELSCOPIC IM SYSTEM, manufactured by Pega Medical, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K041393 · Pega Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
85d
Days
Class 2
Risk

K041393 is an FDA 510(k) clearance for the FASSIER-DUVAL TELSCOPIC IM SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Pega Medical, Inc. (Montreal (Quebec), CA). The FDA issued a Cleared decision on August 17, 2004 after a review of 85 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 Pega Medical, Inc. devices

FDA 510(k) Submission Details - K041393

510(k) Number K041393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2004
Decision Date August 17, 2004
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
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 K041393.
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K040336 · Synthes (Usa) · Apr 2004
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K040462 · Smith & Nephew, Inc. · Mar 2004