Cleared Traditional

K020885 - FASSIRE-DUVAL TELESCOPIC IM SYSTEM

K020885 is an FDA 510(k) clearance for FASSIRE-DUVAL TELESCOPIC 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 325-day FDA review.

K020885 · Pega Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
325d
Days
Class 2
Risk

K020885 is an FDA 510(k) clearance for the FASSIRE-DUVAL TELESCOPIC IM SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Pega Medical, Inc. (Quebec, CA). The FDA issued a Cleared decision on February 6, 2003 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Pega Medical, Inc. devices

FDA 510(k) Submission Details - K020885

510(k) Number K020885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date February 06, 2003
Days to Decision 325 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
203d slower than avg
Panel avg: 122d · This submission: 325d
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 K020885.
GAMMA 3 NAIL SYSTEM
K032244 · Howmedica Osteonics Corp. · Aug 2003
ACUMED SMALL BONE LOCKING ROD SYSTEM II
K031438 · Acumed, LLC · Jul 2003
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K031219 · Orthofix, Inc. · May 2003
TELEGRAPH HUMERAL NAIL
K023241 · Fournitures Hospitalieres Industrie · Dec 2002
ACE VERSANAIL
K023115 · DePuy Orthopaedics, Inc. · Dec 2002
T2 SUPRACONDYLAR NAIL SYSTEM
K023267 · Howmedica Osteonics Corp. · Dec 2002