Intraoperative Orthopedic Joint Assessment Aid
Neurology · 21 CFR 882.4560
Measurement and interpretation of orthopedic joint information.
Recent MDR events
6 adverse event reports on file
- LANTERN HIPMay 1, 2025MalfunctionOrthalign, Inc.3007521480-2025-00012
- LANTERN HIPFeb 26, 2025MalfunctionOrthalign, Inc.3007521480-2025-00005
- LANTERN HIPJan 23, 2025MalfunctionOrthalign, Inc.3007521480-2025-00002
- LANTERN HIPJan 17, 2025MalfunctionOrthalign, Inc.3007521480-2025-00003
- LANTERN HIPJan 17, 2025MalfunctionOrthalign, Inc.3007521480-2025-00004
- ORTHOSENSOR VERASENSE KNEE SYSTEMNov 7, 2016MalfunctionOrthosensor 1855 Griffin RoadMW5065944
Event type breakdown
Most-reported manufacturers
Recalls
8 recall events for this product code
- Orthosensor, Inc.TerminatedJan 29, 2015
Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
Presence of one inoperable (dead) sensor pad.
Z-1029-2015 · View FDA record ↗ - OrthosensorTerminatedOct 24, 2012
"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***"
Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was updated to version 1.82, validated on 02/13/12). Recall was initiated due to customer feedback which included the line of site between the knee ba lancer and the Link station was obstructed by OR metal stands or trays or the knee balancer device was placed atop of or near the metal stands or trays, interru
Z-0122-2013 · View FDA record ↗ - Orthosensor, Inc.TerminatedUnknown
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Z-0082-2019 · View FDA record ↗ - Orthosensor, Inc.TerminatedUnknown
OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Z-0083-2019 · View FDA record ↗ - Orthosensor, Inc.TerminatedUnknown
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Z-0084-2019 · View FDA record ↗ - Orthosensor, Inc.TerminatedUnknown
OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Z-0085-2019 · View FDA record ↗ - Orthosensor, Inc.TerminatedUnknown
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Z-0086-2019 · View FDA record ↗ - Orthosensor, Inc.TerminatedUnknown
OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Z-0087-2019 · View FDA record ↗
Registered firms
15 firms currently registered for this product code
Andersen Caledonia Ltd
Bellshill Scotland, GB
Orthalign, Inc.
Irvine, CA, US
Immetech Industrial Co.,ltd
Dongguan City Guangdong, CN
Medacta International Sa
Rancate Ticino, CH
Sterigenics U.s., Llc
Salt Lake City, UT, US
Europlaz Technologies Ltd.
Southminster Essex, GB
Medacta International Sa
Castel San Pietro Ticino, CH
Depuy Ireland Uc
Co. Cork Munster, IE
Zimmer Cas
MONTREAL, QUEBEC, CA
Eventum Orthopaedics Ltd
Leeds, GB
510(k) clearances
18 clearances for this product code
- Orthalign, Inc.Jul 31, 2026
K262253 · Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03)
- Orthalign, Inc.Jun 2, 2026
K253507 · Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee
- Eventum Orthopaedics, Ltd.Sep 9, 2025
K252524 · Quadsense (Quadsense and Quadsense Pro)
- Eventum Orthopaedics, Ltd.Oct 4, 2024
K241298 · QUADSENSE
- Orthalign, Inc.Oct 3, 2024
K242616 · Lantern® Hip
- These Three Medical, LLCSep 15, 2022
K220830 · TrueBalance Surgical System
- Orthosensor, Inc.Aug 25, 2020
K200587 · 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
- Orthosensor, Inc.Apr 12, 2020
K200665 · VERASENSE for Stryker Triathlon