Cleared Traditional

K955591 - MICROAIRE SMARTDRIVE SYSTEM

K955591 is an FDA 510(k) clearance for MICROAIRE SMARTDRIVE SYSTEM, manufactured by Microaire Surgical Instruments, Inc.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K955591 · Microaire Surgical Instruments, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
42d
Days
Class 1
Risk

K955591 is an FDA 510(k) clearance for the MICROAIRE SMARTDRIVE SYSTEM. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Microaire Surgical Instruments, Inc. (Charlottesville, US). The FDA issued a Cleared decision on January 18, 1996 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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 Microaire Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K955591

510(k) Number K955591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1995
Decision Date January 18, 1996
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 47
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K955591.
HALL MODULAR ACETABULAR REAMER SYSTEM
K960852 · Linvatec Corp. · Mar 1996
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)
K953968 · Aesculap, Inc. · Feb 1996
3M MINI-DRIVER ELECTRIC SYSTEM
K955098 · 3M Company · Jan 1996
CONSENSUS(TM) ORTHOPEDIC DRILL BIT
K950013 · U.S. Medical Products, Inc. · May 1995
CONSENSUS(TM) PATELLA REAMER
K946197 · U.S. Medical Products, Inc. · Apr 1995
CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER
K944946 · U.S. Medical Products, Inc. · Feb 1995