Cleared Traditional

K926547 - MEDNEXT 1000 BONE DISSECTING SYSTEM

K926547 is an FDA 510(k) clearance for MEDNEXT 1000 BONE DISSECTING SYSTEM, manufactured by Mednext, Inc.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K926547 · Mednext, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
203d
Days
Class 1
Risk

K926547 is an FDA 510(k) clearance for the MEDNEXT 1000 BONE DISSECTING SYSTEM. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Mednext, Inc. (West Point Beach, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 203 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 Mednext, Inc. devices

FDA 510(k) Submission Details - K926547

510(k) Number K926547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1992
Decision Date July 22, 1993
Days to Decision 203 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 122d · This submission: 203d
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 32
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K926547.
PNEUMATIC WIRE TENSIONER
K942760 · Smith & Nephew Richards, Inc. · Sep 1994
ARTHREX CIRCULAR HARVESTING SAW
K941681 · Arthrex, Inc. · Aug 1994
PNEUMATIC WIRE TENSIONER
K934431 · Smith & Nephew Richards, Inc. · Jan 1994
A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS
K904949 · Micro-Aire Surgical Instruments, Inc. · Nov 1990
OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
K903713 · Micro-Aire Surgical Instruments, Inc. · Sep 1990
THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM
K901455 · Kirschner Medical Corp. · May 1990