Cleared Traditional

K162237 - XO1 Knee Balancing System

K162237 is an FDA 510(k) clearance for XO1 Knee Balancing System, manufactured by Xpandortho, Inc.. The device is a Class 2 Orthopedic device with product code ONN cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K162237 · Xpandortho, Inc. · Orthopedic device
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Apr 2017
Decision
259d
Days
Class 2
Risk

K162237 is an FDA 510(k) clearance for the XO1 Knee Balancing System. Classified as Intraoperative Orthopedic Joint Assessment Aid (product code ONN), Class II - Special Controls.

Submitted by Xpandortho, Inc. (La Jolla, US). The FDA issued a Cleared decision on April 25, 2017 after a review of 259 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 Xpandortho, Inc. devices

FDA 510(k) Submission Details - K162237

510(k) Number K162237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2016
Decision Date April 25, 2017
Days to Decision 259 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 122d · This submission: 259d
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 K162237.
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K193580 · Orthosensor, Inc. · Apr 2020
VERASENSE for Zimmer Biomet Persona
K180459 · Orthosensor, Inc. · Jun 2018