Cleared Traditional

K942660 - HALL MICROCHOICE ELECTRIC POWERED SYSTEM

K942660 is an FDA 510(k) clearance for HALL MICROCHOICE ELECTRIC POWERED SYSTEM, manufactured by Hall Surgical, Division of Zimmer, Inc.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K942660 · Hall Surgical, Division of Zimmer, Inc. · Orthopedic device
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Sep 1994
Decision
93d
Days
Class 1
Risk

K942660 is an FDA 510(k) clearance for the HALL MICROCHOICE ELECTRIC POWERED SYSTEM. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Hall Surgical, Division of Zimmer, Inc. (Carpinteria, US). The FDA issued a Cleared decision on September 7, 1994 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Hall Surgical, Division of Zimmer, Inc. devices

FDA 510(k) Submission Details - K942660

510(k) Number K942660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1994
Decision Date September 07, 1994
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
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 53
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K942660.
CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER
K945208 · U.S. Medical Products, Inc. · Jan 1995
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
INTERMEDICS ORTHOPEDICS DRILL BITS
K931734 · Intermedics Orthopedics · Feb 1994
ARTHREX AR-8200 SHAVER SYSTEM
K932699 · Arthrex, Inc. · Jan 1994