Cleared Special

K130380 - ORTHOSENSOR KNEE BALANCER

K130380 is an FDA 510(k) clearance for ORTHOSENSOR KNEE BALANCER, manufactured by Orthosensor, Inc.. The device is a Class 2 Orthopedic device with product code ONN cleared through the Special 510(k) pathway after a 119-day FDA review.

K130380 · Orthosensor, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2013
Decision
119d
Days
Class 2
Risk

K130380 is an FDA 510(k) clearance for the ORTHOSENSOR KNEE BALANCER. Classified as Intraoperative Orthopedic Joint Assessment Aid (product code ONN), Class II - Special Controls.

Submitted by Orthosensor, Inc. (Sunrise, US). The FDA issued a Cleared decision on June 13, 2013 after a review of 119 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

FDA 510(k) Submission Details - K130380

510(k) Number K130380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2013
Decision Date June 13, 2013
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Modification to existing cleared device.

ONN Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ONN Intraoperative Orthopedic Joint Assessment Aid

All 9
Devices cleared under the same product code (ONN) and FDA review panel - the closest regulatory comparables to K130380.
VERASENSE for Stryker Triathlon
K200665 · Orthosensor, Inc. · Apr 2020
VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left
K193580 · Orthosensor, Inc. · Apr 2020
VERASENSE for Zimmer Biomet Persona
K180459 · Orthosensor, Inc. · Jun 2018