Cleared Traditional

K945267 - OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES

K945267 is an FDA 510(k) clearance for OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES, manufactured by Optus, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K945267 · Optus, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
207d
Days
Class 2
Risk

K945267 is an FDA 510(k) clearance for the OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Optus, Inc. (Denver, US). The FDA issued a Cleared decision on May 23, 1995 after a review of 207 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.

View all Optus, Inc. devices

FDA 510(k) Submission Details - K945267

510(k) Number K945267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1994
Decision Date May 23, 1995
Days to Decision 207 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
85d slower than avg
Panel avg: 122d · This submission: 207d
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 394
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K945267.
GORE SMOOTHER GUIDED RASP
K951163 · W.L. Gore & Associates, Inc. · Jun 1995
ARTHROSCOPIC TELESCOPES
K943052 · Karl Storz Endoscopy · May 1995
ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011
K940179 · Richard Wolf Medical Instruments Corp. · May 1995
DANEK RIGID ARTHROSCOPE
K950501 · Sofamor Danek USA,Inc. · May 1995
KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP
K950561 · KARL STORZ Endoscopy-America, Inc. · May 1995
INCLUSIVE ENDOSCOPE
K943356 · Danek Medical, Inc. · May 1995