ONN · Class II · 21 CFR 882.4560

FDA Product Code ONN: Intraoperative Orthopedic Joint Assessment Aid

Measurement And Interpretation Of Orthopedic Joint Information.

Leading manufacturers include Orthosensor, Inc., Orthalign, Inc. and Synvasive Technology, Inc..

18
Total
18
Cleared
172d
Avg days
2007
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 90d recently vs 189d historically

FDA 510(k) Cleared Intraoperative Orthopedic Joint Assessment Aid Devices (Product Code ONN)

18 devices
1–18 of 18
Cleared Jul 31, 2026
Lantern Knee Navigation Unit (406000-03)
K262253
Orthalign, Inc.
Orthopedic · 29d
Cleared Jun 02, 2026
Packaged Assembly, Reusable Navigation Unit
K253507
Orthalign, Inc.
Orthopedic · 211d
Cleared Sep 09, 2025
Quadsense (Quadsense and Quadsense Pro)
K252524
Eventum Orthopaedics, Ltd.
Orthopedic · 29d
Cleared Oct 04, 2024
QUADSENSE
K241298
Eventum Orthopaedics, Ltd.
Orthopedic · 149d
Cleared Oct 03, 2024
Lantern® Hip
K242616
Orthalign, Inc.
Orthopedic · 30d
Cleared Sep 15, 2022
TrueBalance™ Surgical System
K220830
These Three Medical, LLC
Orthopedic · 177d
Cleared Aug 25, 2020
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.
Orthopedic · 172d
Cleared Apr 12, 2020
VERASENSE for Stryker Triathlon
K200665
Orthosensor, Inc.
Orthopedic · 30d
Cleared Apr 01, 2020
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
K193580
Orthosensor, Inc.
Orthopedic · 100d
Cleared Jun 07, 2018
VERASENSE for Zimmer Biomet Persona
K180459
Orthosensor, Inc.
Orthopedic · 107d
Cleared Apr 25, 2017
XO1 Knee Balancing System
K162237
Xpandortho, Inc.
Orthopedic · 259d
Cleared Apr 15, 2016
VERASENSE Knee System
K150372
Orthosensor, Inc.
Orthopedic · 427d
Cleared Mar 21, 2014
ELIBRA SOFT-TISSUE FORCE SENSOR
K132104
Kamm & Associates
Orthopedic · 256d
Cleared Nov 08, 2013
ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
K131767
Orthosensor, Inc.
Orthopedic · 144d
Cleared Jun 13, 2013
ORTHOSENSOR KNEE BALANCER
K130380
Orthosensor, Inc.
Orthopedic · 119d
Cleared Mar 22, 2011
ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES
K093046
Synvasive Technology, Inc.
Orthopedic · 538d
Cleared Oct 19, 2009
ORTHOREX INTRA-OPERATIVE LOAD SENSOR
K090474
Orthosensor, Inc.
Orthopedic · 237d
Cleared Apr 04, 2007
ELIBRA DYNAMIC KNEE BALANCER
K070108
Synvasive Technology, Inc.
Orthopedic · 83d

About Product Code ONN - Regulatory Context

510(k) Submission Activity

18 total 510(k) submissions under product code ONN since 2007, with 18 receiving FDA clearance (average review time: 172 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - ONN Product Code

Recent submissions under ONN have taken an average of 90 days to reach a decision - down from 189 days historically, suggesting improved FDA processing for this classification.

ONN devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →