Cleared Traditional

K093062 - VERTOS MEDICAL MILD DEVICE KIT

K093062 is an FDA 510(k) clearance for VERTOS MEDICAL MILD DEVICE KIT, manufactured by X-Sten Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K093062 · X-Sten Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
127d
Days
Class 2
Risk

K093062 is an FDA 510(k) clearance for the VERTOS MEDICAL MILD DEVICE KIT. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by X-Sten Corp. (Alameda, US). The FDA issued a Cleared decision on February 4, 2010 after a review of 127 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.

FDA 510(k) Submission Details - K093062

510(k) Number K093062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2009
Decision Date February 04, 2010
Days to Decision 127 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 122d · This submission: 127d
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 648
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K093062.
STRYKER ARTHROSCOPE
K093677 · Stryker Endoscopy · Mar 2010
C-MOR VISUALIZATION DEVICE
K093717 · Axis Surgical Technologies, Inc. · Mar 2010
POWERPUMP ARTHROSCOPY SYSTEM
K093409 · Medical Vision AB · Feb 2010
INDISCAL ASPIRATION DEVICE AND ACCESSORIES
K092877 · Baylis Medical Co., Inc. · Nov 2009
MAXMORESPINE TOM STICK
K083552 · Hoogland Spine Products, GmbH · Oct 2009
SPINAL FORAMINOSCOPE
K082841 · Blazejewski Medi-Tech GmbH · Sep 2009
K093062 · VERTOS MEDICAL MILD DEVICE KIT
Download PDF FDA Summary X-Sten Corp.