Cleared Traditional

K953968 - AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON)

K953968 is an FDA 510(k) clearance for AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON), manufactured by Aesculap, Inc.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K953968 · Aesculap, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
167d
Days
Class 1
Risk

K953968 is an FDA 510(k) clearance for the AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON). Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on February 5, 1996 after a review of 167 days - an extended review 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: 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K953968

510(k) Number K953968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1995
Decision Date February 05, 1996
Days to Decision 167 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
45d slower than avg
Panel avg: 122d · This submission: 167d
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 52
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K953968.
CEMENT AND BONE REMOVAL KIT
K961759 · Maillefer Instruments S.A. · Jun 1996
EXACTECH STERILE MODULAR DRILL BIT
K960720 · Exactech, Inc. · Apr 1996
HALL MODULAR ACETABULAR REAMER SYSTEM
K960852 · Linvatec Corp. · Mar 1996
3M MINI-DRIVER ELECTRIC SYSTEM
K955098 · 3M Company · Jan 1996
MICROAIRE SMARTDRIVE SYSTEM
K955591 · Microaire Surgical Instruments, Inc. · Jan 1996
CONSENSUS(TM) ORTHOPEDIC DRILL BIT
K950013 · U.S. Medical Products, Inc. · May 1995