Cleared Traditional

K023267 - T2 SUPRACONDYLAR NAIL SYSTEM

K023267 is the FDA 510(k) clearance for T2 SUPRACONDYLAR NAIL SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K023267 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
72d
Days
Class 2
Risk

K023267 is an FDA 510(k) clearance for the T2 SUPRACONDYLAR 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 December 11, 2002 after a review of 72 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K023267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2002
Decision Date December 11, 2002
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 323
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K023267.
ACUMED SMALL BONE LOCKING ROD SYSTEM II
K031438 · Acumed, LLC · Jul 2003
MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K031219 · Orthofix, Inc. · May 2003
ACE VERSANAIL
K023115 · DePuy Orthopaedics, Inc. · Dec 2002
TITANIUM ANKLE ARTHRODESIS NAIL
K021786 · Biomet, Inc. · Aug 2002
S2 TIBIAL NAIL
K022481 · Howmedica Osteonics Corp. · Aug 2002
T2 FEMORAL NAIL
K021744 · Howmedica Osteonics Corp. · Jun 2002