Cleared Traditional

VERASENSE Knee System (K150372) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K150372 · Orthosensor, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
427d
Days
Class 2
Risk

K150372 is an FDA 510(k) clearance for the 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 April 15, 2016 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Orthosensor, Inc. devices

Submission Details

510(k) Number K150372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2015
Decision Date April 15, 2016
Days to Decision 427 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
305d slower than avg
Panel avg: 122d · This submission: 427d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - ONN Intraoperative Orthopedic Joint Assessment Aid

All 16
Devices cleared under the same product code (ONN) and FDA review panel - the closest regulatory comparables to K150372.
Packaged Assembly, Reusable Navigation Unit
K253507 · Orthalign, Inc. · Jun 2026
Quadsense (Quadsense and Quadsense Pro)
K252524 · Eventum Orthopaedics, Ltd. · Sep 2025
QUADSENSE
K241298 · Eventum Orthopaedics, Ltd. · Oct 2024
Lantern® Hip
K242616 · Orthalign, Inc. · Oct 2024
TrueBalance™ Surgical System
K220830 · These Three Medical, LLC · Sep 2022
VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder
K200587 · Orthosensor, Inc. · Aug 2020