Cleared Traditional

K945973 - FMS ARTHROSCOPY CANNULA

K945973 is an FDA 510(k) clearance for FMS ARTHROSCOPY CANNULA, manufactured by Future Medical Systems, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K945973 · Future Medical Systems, Inc. · Orthopedic device
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Mar 1995
Decision
104d
Days
Class 2
Risk

K945973 is an FDA 510(k) clearance for the FMS ARTHROSCOPY CANNULA. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Future Medical Systems, Inc. (New York City, US). The FDA issued a Cleared decision on March 22, 1995 after a review of 104 days - within the typical 510(k) review window.

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.

View all Future Medical Systems, Inc. devices

FDA 510(k) Submission Details - K945973

510(k) Number K945973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1994
Decision Date March 22, 1995
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 514
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K945973.
CLARUS PHOENIX ENDOSCOPE
K940144 · Clarus Medical Systems, Inc. · Apr 1995
CLARUS NEURO ENDOSCOPE (MODEL 2230)
K941188 · Clarus Medical Systems, Inc. · Apr 1995
ACUFEX ARTHROSCOPIC DISCECTOMY SYSTEMS
K941709 · Acufex Microsurgical, Inc. · Apr 1995
ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
K943450 · Arthrocare Corp. · Mar 1995
ARTHROSCOPE ACCESSORIES
K944210 · Stryker Endoscopy · Feb 1995
CTS RELIEF KIT
K941651 · Linvatec Corp. · Jan 1995