Cleared Special

K131767 - ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K131767 · Orthosensor, Inc. · Orthopedic device
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Nov 2013
Decision
144d
Days
Class 2
Risk

K131767 is an FDA 510(k) clearance for the ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM. Classified as Intraoperative Orthopedic Joint Assessment Aid (product code ONN), Class II - Special Controls.

Submitted by Orthosensor, Inc. (Dania Beach, US). The FDA issued a Cleared decision on November 8, 2013 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orthosensor, Inc. devices

Submission Details

510(k) Number K131767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2013
Decision Date November 08, 2013
Days to Decision 144 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 122d · This submission: 144d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ONN Intraoperative Orthopedic Joint Assessment Aid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Measurement And Interpretation Of Orthopedic Joint Information.
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.