Cleared Traditional

K912108 - BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS

K912108 is an FDA 510(k) clearance for BLADES, manufactured by Microaire Advanced Surgical Products. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K912108 · Microaire Advanced Surgical Products · Orthopedic device
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Jul 1991
Decision
50d
Days
Class 2
Risk

K912108 is an FDA 510(k) clearance for the BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Microaire Advanced Surgical Products (Valencia, US). The FDA issued a Cleared decision on July 2, 1991 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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.

FDA 510(k) Submission Details - K912108

510(k) Number K912108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date July 02, 1991
Days to Decision 50 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 630
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K912108.
PALMER ARCH SUPPRESSOR
K913347 · Smith & Nephew Dyonics, Inc. · Sep 1991
INTELIJET TM FLUID MANAGEMENT SYSTEM
K912453 · Smith & Nephew Dyonics, Inc. · Aug 1991
INSIDE JOB
K912871 · 3M Health Care, Ltd. · Aug 1991
ARTHROSCOPY INSTRUMENT CANNULA
K911205 · Davol, Inc. · Jun 1991
STRYKER ARTHROSCOPIC INFUSION PUMP
K910858 · Stryker Corp. · May 1991
FLEXMEDICS MALLEABLE CANNULA
K910674 · Flexmedics · Apr 1991
K912108 · BLADES, WHISKERS, TRIMMERS, CUTTERS, AND BURS
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