Orthosensor Inc
United StatesFDA applicant, unverified
- Devices
- 180
- FDA recalls
- 8
At a glance
Market reach
- United States
- FDA recalls
What Orthosensor Inc makes
Orthosensor Inc manufactures intraoperative load sensors and software applications designed for knee and shoulder joint replacements, including systems like the VERASENSE Knee System and the ORTHOSENSOR KNEE BALANCER. These devices integrate with specific implant brands, such as Stryker, Exactech, and Zimmer Biomet, to provide real-time feedback during surgical procedures. Additional offerings include standalone intraoperative load sensors like the ORTHOREX INTRA-OPERATIVE LOAD SENSOR and evaluation kits for testing. The VERASENSE Software Application for Shoulder is also part of the portfolio, enabling data collection during shoulder arthroplasty.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. medical device regulations. Orthosensor Inc operates from the United States, where its portfolio is subject to FDA oversight.
Catalogue
Search and filter all 180 devicesShowing 1-50 of 180
Company details
- DUNS number
- 005788130
- [email protected]
- Phone
- 954-577-7770
FDA recalls
FDA recall records list 8 recalls initiated by ORTHOSENSOR INC, the earliest on 2012-02-04 and the most recent on 2018-07-12. By recorded status: 8 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 6
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 12 Jul 2018 Z-0082-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Full distribution text
- 12 Jul 2018 Z-0083-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Full distribution text
- 12 Jul 2018 Z-0084-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Full distribution text
- 12 Jul 2018 Z-0085-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Full distribution text
- 12 Jul 2018 Z-0086-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Full distribution text
- 12 Jul 2018 Z-0087-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
Full distribution text
- 12 Jul 2018 Z-0082-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
2014
- 5 Dec 2014 Z-1029-2015 Class II Terminated Presence of one inoperable (dead) sensor pad.
2012
- 4 Feb 2012 Z-0122-2013 Class II Terminated 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
Frequently asked questions
How many devices does ORTHOSENSOR INC have in the registry?
The registry currently lists 180 devices for ORTHOSENSOR INC. Devices recorded under merged duplicate company entries are counted once.
Which registries list ORTHOSENSOR INC's devices?
Among its 50 most recently registered devices, ORTHOSENSOR INC has devices listed in FDA GUDID (50 devices).
What risk classes do ORTHOSENSOR INC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for ORTHOSENSOR INC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ORTHOSENSOR INC?
FDA recall records list 8 recalls initiated by ORTHOSENSOR INC, the most recent initiated on 12 Jul 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from ORTHOSENSOR INC in the registry?
The most recently registered devices listed for ORTHOSENSOR INC include LinkStation MINI, VERASENSE for Zimmer NexGen PS E-F/3-4, VERASENSE and VERASENSE for Stryker Triathlon size 3.