Cleared Traditional

K083458 - INTRAMEDULLARY FIXATION ROD (IFS)

K083458 is an FDA 510(k) clearance for INTRAMEDULLARY FIXATION ROD (IFS), manufactured by Novalign Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K083458 · Novalign Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
80d
Days
Class 2
Risk

K083458 is an FDA 510(k) clearance for the INTRAMEDULLARY FIXATION ROD (IFS). Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Novalign Orthopaedics, Inc. (Memphis, US). The FDA issued a Cleared decision on February 9, 2009 after a review of 80 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 Novalign Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K083458

510(k) Number K083458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2008
Decision Date February 09, 2009
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
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 398
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K083458.
AOS PROXIMAL HUMERAL NAIL
K090478 · Advanced Orthopaedic Solutions, Inc. · Mar 2009
PEDINAIL INTRAMEDULLARY NAILING SYSTEM
K083726 · OrthoPediatrics Corp. · Mar 2009
ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS
K083497 · Zimmer, Inc. · Feb 2009
AEQUALIS HUMERAL NAIL SYSTEM
K082754 · Tornier · Jan 2009
MODIFICATION TO T2 RECON NAIL SYSTEM
K083437 · Howmedica Osteonics Corp. · Dec 2008
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL
K082770 · Zimmer, Inc. · Dec 2008