Orthosensor Inc

United StatesFDA applicant, unverified

Devices: 180
FDA recalls: 8

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue180

Newest first, rows 51-100 of 180

Search and filter all 180 devices

Rows 51-100 of 180

Showing 51-100 of 180

Company details

DUNS number: 005788130
Email: [email protected]
Phone: 954-577-7770

FDA recalls8

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

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.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 0
2018 6
2019 0
2020 0
2021 0
2022 0
2023 0
2024 0
2025 0
2026 0

2 initiated before 2017

2018
- 12 Jul 2018 Z-0082-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. Distribution: Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no…
  Full distribution text
  Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
  Submission number: K180459
- 12 Jul 2018 Z-0083-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. Distribution: Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no…
  Full distribution text
  Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
  Submission number: K180459
- 12 Jul 2018 Z-0084-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. Distribution: Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no…
  Full distribution text
  Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
  Submission number: K180459
- 12 Jul 2018 Z-0085-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. Distribution: Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no…
  Full distribution text
  Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
  Submission number: K180459
- 12 Jul 2018 Z-0086-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. Distribution: Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no…
  Full distribution text
  Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
  Submission number: K180459
- 12 Jul 2018 Z-0087-2019 Class II Terminated Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. Distribution: Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no…
  Full distribution text
  Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.
  Submission number: K180459
2014
- 5 Dec 2014 Z-1029-2015 Class II Terminated Presence of one inoperable (dead) sensor pad. Distribution: US Distribution to the states of : IL, MI, NY, CA, VA and NV. Submission number: K130380
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 Distribution: Nationwide Distribution including the states of CA, FL, MI and NY.