Cleared Traditional

K900210 - BONE HARVESTER SYSTEM & OSTEOTOME SYSTE...

K900210 is an FDA 510(k) clearance for BONE HARVESTER SYSTEM & OSTEOTOME SYSTE..., 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 16-day FDA review.

K900210 · Micro-Aire Surgical Instruments, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
16d
Days
Class 1
Risk

K900210 is an FDA 510(k) clearance for the BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500. 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 February 2, 1990 after a review of 16 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 - K900210

510(k) Number K900210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1990
Decision Date February 02, 1990
Days to Decision 16 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
106d faster than avg
Panel avg: 122d · This submission: 16d
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 K900210.
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
INTERMEDICS POWER BROACH IMPACTOR
K895121 · Intermedics Orthopedics · Sep 1989
CONCEPT POWER SYSTEM
K881954 · Concept, Inc. · Nov 1988
ARTUS DISPOSABLE SHEATHS/CUTTERS
K880881 · Acufex Microsurgical, Inc. · May 1988