Cleared Special

K252524 - Quadsense (Quadsense and Quadsense Pro) (FDA 510(k) Clearance)

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

K252524 · Eventum Orthopaedics, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
29d
Days
Class 2
Risk

K252524 is an FDA 510(k) clearance for the Quadsense (Quadsense and Quadsense Pro). Classified as Intraoperative Orthopedic Joint Assessment Aid (product code ONN), Class II - Special Controls.

Submitted by Eventum Orthopaedics, Ltd. (Leeds, GB). The FDA issued a Cleared decision on September 9, 2025 after a review of 29 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Eventum Orthopaedics, Ltd. devices

Submission Details

510(k) Number K252524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2025
Decision Date September 09, 2025
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
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.

Regulatory Consultant

Hogan Lovells US LLP
Kelliann Payne

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.