Cleared Traditional

K123363 - SUPER STAPLE(TM) CLASSIC

K123363 is an FDA 510(k) clearance for SUPER STAPLE(TM) CLASSIC, manufactured by Metric Medical Devices, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 63-day FDA review.

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

FDA 510(k) Submission Details - K123363

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
Combination Product No
PCCP Authorized No
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.

JDR Device Classification - Class 2, Special Controls

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 210
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K123363.
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VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
K112837 · Vilex, Inc. · Oct 2012
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K102387 · Mediscope Manufacturing, Inc. · Oct 2011
SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM
K102143 · Suspension Orthopaedic Solutions, LLC · Dec 2010