Cleared Special

K032898 - T2 RECON NAIL SYSTEM

K032898 is the FDA 510(k) clearance for T2 RECON NAIL SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Special 510(k) pathway after a 22-day FDA review.

K032898 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
22d
Days
Class 2
Risk

K032898 is an FDA 510(k) clearance for the T2 RECON NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on October 9, 2003 after a review of 22 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K032898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2003
Decision Date October 09, 2003
Days to Decision 22 days
Submission Type Special
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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 323
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K032898.
GAMMA3 NAIL SYSTEM
K034002 · Howmedica Osteonics Corp. · Jan 2004
DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
K033329 · Depuy, Inc. · Nov 2003
T2 NAILING SYSTEM
K032523 · Howmedica Osteonics Corp. · Oct 2003
TRIGEN STRAIGHT HUMERAL NAIL SYSTEM
K032722 · Smith & Nephew, Inc. · Oct 2003
IP-XS COMPRESSION NAIL SYSTEM
K032548 · Plus Orthopedics · Sep 2003
S2 NAIL SYSTEM
K032579 · Howmedica Osteonics Corp. · Aug 2003