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ONN — Intraoperative Orthopedic Joint Assessment Aid Class II

FDA Device Classification

Classification Details

Product Code
ONN
Device Class
Class II
Regulation Number
882.4560
Submission Type
Review Panel
OR
Medical Specialty
Neurology
Implant
No

Definition

Measurement and interpretation of orthopedic joint information.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252524eventum orthopaedicsQuadsense (Quadsense and Quadsense Pro)September 9, 2025
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K220830these three medicalTrueBalance™ Surgical SystemSeptember 15, 2022
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K200665orthosensorVERASENSE for Stryker TriathlonApril 12, 2020
K193580orthosensorVERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer BiometApril 1, 2020
K180459orthosensorVERASENSE for Zimmer Biomet PersonaJune 7, 2018
K162237xpandorthoXO1 Knee Balancing SystemApril 25, 2017
K150372orthosensorVERASENSE Knee SystemApril 15, 2016
K132104kamm and associatesELIBRA SOFT-TISSUE FORCE SENSORMarch 21, 2014
K131767orthosensorORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEMNovember 8, 2013
K130380orthosensorORTHOSENSOR KNEE BALANCERJune 13, 2013
K093046synvasive technologyELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZESMarch 22, 2011
K090474orthosensorORTHOREX INTRA-OPERATIVE LOAD SENSOROctober 19, 2009
K070108synvasive technologyELIBRA DYNAMIC KNEE BALANCERApril 4, 2007