Atlas FDA

ONN

18 FDA 510(k) clearances · Product code

149 daysmedian time to decision
427 days90th percentile
18clearances measured

FDA profile

Official device name
Intraoperative Orthopedic Joint Assessment Aid
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4560
Medical specialty
Neurology
FDA definition
Measurement and interpretation of orthopedic joint information.
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RecordFirmDate
Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) (K262253)Orthalign, Inc.2026-07-31
Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee (K253507)Orthalign, Inc.2026-06-02
Quadsense (Quadsense and Quadsense Pro) (K252524)Eventum Orthopaedics, Ltd.2025-09-09
QUADSENSE (K241298)Eventum Orthopaedics, Ltd.2024-10-04
Lantern® Hip (K242616)Orthalign, Inc.2024-10-03
TrueBalance™ Surgical System (K220830)These Three Medical, LLC2022-09-15
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.2020-08-25
VERASENSE for Stryker Triathlon (K200665)Orthosensor, Inc.2020-04-12
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.2020-04-01
VERASENSE for Zimmer Biomet Persona (K180459)Orthosensor, Inc.2018-06-07
XO1 Knee Balancing System (K162237)Xpandortho, Inc.2017-04-25
VERASENSE Knee System (K150372)Orthosensor, Inc.2016-04-15
ELIBRA SOFT-TISSUE FORCE SENSOR (K132104)Kamm & Associates2014-03-21
ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM (K131767)Orthosensor, Inc.2013-11-08
ORTHOSENSOR KNEE BALANCER (K130380)Orthosensor, Inc.2013-06-13
ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES (K093046)Synvasive Technology, Inc.2011-03-22
ORTHOREX INTRA-OPERATIVE LOAD SENSOR (K090474)Orthosensor, Inc.2009-10-19
ELIBRA DYNAMIC KNEE BALANCER (K070108)Synvasive Technology, Inc.2007-04-04

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Every clearance here is in the API, with alerts when new ones post.