Cleared Traditional

K090474 - ORTHOREX INTRA-OPERATIVE LOAD SENSOR

K090474 is an FDA 510(k) clearance for ORTHOREX INTRA-OPERATIVE LOAD SENSOR, manufactured by Orthosensor, Inc.. The device is a Class 2 Orthopedic device with product code ONN cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K090474 · Orthosensor, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
237d
Days
Class 2
Risk

K090474 is an FDA 510(k) clearance for the ORTHOREX INTRA-OPERATIVE LOAD SENSOR. Classified as Intraoperative Orthopedic Joint Assessment Aid (product code ONN), Class II - Special Controls.

Submitted by Orthosensor, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on October 19, 2009 after a review of 237 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 Orthosensor, Inc. devices

FDA 510(k) Submission Details - K090474

510(k) Number K090474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2009
Decision Date October 19, 2009
Days to Decision 237 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
115d slower than avg
Panel avg: 122d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K090474.
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