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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

by Orthosensor Inc

510(k) K193580

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK193580 Date1 Apr 2020ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ONN
FDA applicant
Orthosensor, Inc.
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VERASENSE is an Intraoperative Orthopedic Joint Assessment Aid, designed to evaluate implant alignment during Total Knee Arthroplasty (TKA). It provides real-time feedback to assist surgeons in adjusting the femoral knee implant, helping to mitigate instability caused by flexion gap asymmetry.

Supplied sterile for single-patient use, the device is intended for intraoperative application in orthopedic procedures. Authorized under FDA 510(k) clearance (K193580), it adheres to Class II regulatory standards (ONN product code) and is intended for use in neurology-related orthopedic assessments. No additional storage or handling instructions are specified beyond standard sterile surgical protocols.

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