Cleared Traditional

K904949 - A.O. SYNTHES

K904949 is an FDA 510(k) clearance for A.O. SYNTHES, manufactured by Micro-Aire Surgical Instruments, Inc.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K904949 · Micro-Aire Surgical Instruments, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Nov 1990
Decision
24d
Days
Class 1
Risk

K904949 is an FDA 510(k) clearance for the A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on November 26, 1990 after a review of 24 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 Micro-Aire Surgical Instruments, Inc. devices

FDA 510(k) Submission Details - K904949

510(k) Number K904949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1990
Decision Date November 26, 1990
Days to Decision 24 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
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 31
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K904949.
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
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
BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
K900210 · Micro-Aire Surgical Instruments, Inc. · Feb 1990