Cleared Traditional

K941681 - ARTHREX CIRCULAR HARVESTING SAW

K941681 is an FDA 510(k) clearance for ARTHREX CIRCULAR HARVESTING SAW, manufactured by Arthrex, Inc.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K941681 · Arthrex, Inc. · Orthopedic device
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Aug 1994
Decision
142d
Days
Class 1
Risk

K941681 is an FDA 510(k) clearance for the ARTHREX CIRCULAR HARVESTING SAW. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on August 25, 1994 after a review of 142 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.

FDA 510(k) Submission Details - K941681

510(k) Number K941681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1994
Decision Date August 25, 1994
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

HSZ Device Classification - Class 1, General Controls

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & 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 - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

All 55
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K941681.
SPINALPLANE
K934336 · Synvasive Technology, Inc. · Mar 1995
FILTER, DIFFUSER
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TAVA WIRE-DRIVER
K935367 · Tava Surgical Instruments · Apr 1994
PNEUMATIC WIRE TENSIONER
K934431 · Smith & Nephew Richards, Inc. · Jan 1994
THE DE SOUTTER M193 REAMER
K930784 · De Soutter Medical, Ltd. · Oct 1993
K941681 · ARTHREX CIRCULAR HARVESTING SAW
Download PDF Arthrex, Inc.