Cleared Traditional

K955098 - 3M MINI-DRIVER ELECTRIC SYSTEM

K955098 is the FDA 510(k) clearance for 3M MINI-DRIVER ELECTRIC SYSTEM by 3M Company. It is a Class 1 Orthopedic device (product code HWE) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K955098 · 3M Company · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
76d
Days
Class 1
Risk

K955098 is an FDA 510(k) clearance for the 3M MINI-DRIVER ELECTRIC SYSTEM. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 76 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 3M Company devices

Submission Details

510(k) Number K955098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1995
Decision Date January 22, 1996
Days to Decision 76 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
46d faster than avg
Panel avg: 122d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 33
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K955098.
EXACTECH STERILE MODULAR DRILL BIT
K960720 · Exactech, Inc. · Apr 1996
HALL MODULAR ACETABULAR REAMER SYSTEM
K960852 · Linvatec Corp. · Mar 1996
AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)
K953968 · Aesculap, Inc. · Feb 1996
STRYKER TOTAL PERFORMANCE SYSTEM
K943589 · Stryker Corp. · Dec 1994
SURGICAL INSTRUMENTS AND ACCESSORIES
K942956 · Stryker Corp. · Sep 1994
TOTAL KNEE KIT
K932918 · Biodynamic Technologies, Inc. · Sep 1994