Cleared Traditional

Fassier-Duval Telescoping IM System (K241983) - FDA 510(k) Clearance

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

K241983 · Orthopediatrics Canada Ulc Dba Pega Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
228d
Days
Class 2
Risk

K241983 is an FDA 510(k) clearance for the Fassier-Duval Telescoping IM System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthopediatrics Canada Ulc Dba Pega Medical (Laval, CA). The FDA issued a Cleared decision on February 21, 2025 after a review of 228 days - an extended review 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: 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 Orthopediatrics Canada Ulc Dba Pega Medical devices

Submission Details

510(k) Number K241983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2024
Decision Date February 21, 2025
Days to Decision 228 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
106d slower than avg
Panel avg: 122d · This submission: 228d
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 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 K241983.
ARIX Femur Nail System
K242247 · Jeil Medical Corporation · Apr 2025
FitboneTM Trochanteric
K250112 · Orthofix Srl · Apr 2025
Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
K250623 · OrthoPediatrics Corp. · Apr 2025
Affixus Tibial Nailing System - 4mm screws
K243907 · Zimmer, Inc. · Feb 2025
Arthrex Intramedullary Nails
K243890 · Arthrex, Inc. · Jan 2025
TRIGEN META-TAN Trochanteric Antegrade Nail
K243364 · Smith & Nephew, Inc. · Dec 2024