Cleared Traditional

K961759 - CEMENT AND BONE REMOVAL KIT

K961759 is an FDA 510(k) clearance for CEMENT AND BONE REMOVAL KIT, manufactured by Maillefer Instruments S.A.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K961759 · Maillefer Instruments S.A. · Orthopedic device
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Jun 1996
Decision
37d
Days
Class 1
Risk

K961759 is an FDA 510(k) clearance for the CEMENT AND BONE REMOVAL KIT. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Maillefer Instruments S.A. (Moorpark, US). The FDA issued a Cleared decision on June 13, 1996 after a review of 37 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 Maillefer Instruments S.A. devices

FDA 510(k) Submission Details - K961759

510(k) Number K961759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1996
Decision Date June 13, 1996
Days to Decision 37 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 122d · This submission: 37d
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 K961759.
CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER
K962215 · U.S. Medical Products, Inc. · Aug 1996
POWERCUT GOLD SURGICAL SYSTEM
K962022 · Baxter Healthcare Corp · Aug 1996
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
K961970 · Stryker Corp. · Jul 1996
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