Cleared Traditional

SUPER STAPLE(TM) CLASSIC (K123363) - FDA 510(k) Clearance

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

K123363 · Metric Medical Devices, Inc. · Orthopedic device
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Jan 2013
Decision
63d
Days
Class 2
Risk

K123363 is an FDA 510(k) clearance for the SUPER STAPLE(TM) CLASSIC. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Metric Medical Devices, Inc. (Helotes, US). The FDA issued a Cleared decision on January 3, 2013 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Metric Medical Devices, Inc. devices

Submission Details

510(k) Number K123363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2012
Decision Date January 03, 2013
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 66
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K123363.
ExoToe Staple
K172205 · Exotoe, LLC · Jan 2018
Arthrex DynaNite Nitinol Staple
K172052 · Arthrex, Inc. · Dec 2017
MEMORY METAL STAPLES, EASYCLIP
K122113 · Stryker Corp. · Mar 2013
ARTHREX COMPRESSION STAPLE
K080111 · Arthrex, Inc. · Feb 2008
MEMORY STAPLE
K060746 · DePuy Orthopaedics, Inc. · May 2006
COMPRESSION STAPLE AND SIMPLE STAPLE
K043059 · Wrightmedicaltechnologyinc · Jan 2005