Cleared Traditional

K912099 - 3M FLUID CONTROL SYSTEM SMALL JOINT COP...

K912099 is an FDA 510(k) clearance for 3M FLUID CONTROL SYSTEM SMALL JOINT COP..., manufactured by 3M Company. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K912099 · 3M Company · Orthopedic device
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Dec 1991
Decision
210d
Days
Class 2
Risk

K912099 is an FDA 510(k) clearance for the 3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 210 days - an extended review 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: 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.

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FDA 510(k) Submission Details - K912099

510(k) Number K912099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1991
Decision Date December 09, 1991
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
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 393
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K912099.
INTEGRATED ENDOSCOPY SYSTEM 1000
K920800 · Biomet, Inc. · Jun 1992
MODEL AR-6300 INFUSION PUMP
K915721 · Arthrex, Inc. · Mar 1992
DANEK SPINALSCOPE
K901692 · Danek Medical, Inc. · Feb 1992
ARTHRO-FLOW IRRIGATION 2 SYSTEM
K913028 · Davol, Inc. · Oct 1991
CONCEPT MICROMILL
K912957 · Concept, Inc. · Oct 1991
INSIDE JOB
K912871 · 3M Health Care, Ltd. · Aug 1991