Cleared Traditional

K913289 - MASTERPIECES(TM)/MICRO/MINI SYSTEMS (FDA 510(k) Clearance)

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

K913289 · Storz Instrument Co. · Orthopedic device
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Sep 1991
Decision
43d
Days
Class 2
Risk

K913289 is an FDA 510(k) clearance for the MASTERPIECES(TM)/MICRO/MINI SYSTEMS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on September 5, 1991 after a review of 43 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 Storz Instrument Co. devices

Submission Details

510(k) Number K913289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1991
Decision Date September 05, 1991
Days to Decision 43 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 122d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 1306
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