Cleared Traditional

K133941 - MITEK ARTHROSCOPES

K133941 is an FDA 510(k) clearance for MITEK ARTHROSCOPES, manufactured by Medos International SARL. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K133941 · Medos International SARL · Orthopedic device
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Apr 2014
Decision
116d
Days
Class 2
Risk

K133941 is an FDA 510(k) clearance for the MITEK ARTHROSCOPES. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on April 18, 2014 after a review of 116 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 Medos International SARL devices

FDA 510(k) Submission Details - K133941

510(k) Number K133941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2013
Decision Date April 18, 2014
Days to Decision 116 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 122d · This submission: 116d
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 530
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K133941.
NUVIS ARTHROSCOPE
K140903 · Integrated Endoscopy, Inc. · Jul 2014
VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
K141002 · Visionsense, Ltd. · Jun 2014
SCHOELLY ARTHROSCOPE
K133682 · Scholly Fiberoptic GmbH · Jun 2014
DISCOSCOPES, CERVICAL ENDOSCOPES
K130778 · Rz Medizintechnik GmbH · Apr 2014
OSI Q SYSTEM ARTHROSCOPES
K133018 · Orthopedic Sciences, Inc. · Feb 2014
ESPIN SYSTEM
K133061 · Nlt Spine, Ltd. · Nov 2013