Orthosensor, Inc.
Appollo Beach, FL, US
Orthosensor, Inc. appears in FDA device records in Appollo Beach, FL. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 8 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Orthosensor, Inc. between 2009 and 2020. The busiest year on record is 2020, with 3. The most recent is 2020, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2013 | 2 |
| 2016 | 1 |
| 2018 | 1 |
| 2020 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | ONN | Substantially Equivalent | |
| K200665 | VERASENSE for Stryker Triathlon | ONN | Substantially Equivalent | |
| K193580 | 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 | ONN | Substantially Equivalent | |
| K180459 | VERASENSE for Zimmer Biomet Persona | ONN | Substantially Equivalent | |
| K150372 | VERASENSE Knee System | ONN | Substantially Equivalent | |
| K131767 | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM | ONN | Substantially Equivalent | |
| K130380 | ORTHOSENSOR KNEE BALANCER | ONN | Substantially Equivalent | |
| K090474 | ORTHOREX INTRA-OPERATIVE LOAD SENSOR | ONN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0087-2019 | 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. | Class II | Terminated | |
| Z-0086-2019 | 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. | Class II | Terminated | |
| Z-0085-2019 | 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. | Class II | Terminated | |
| Z-0084-2019 | 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. | Class II | Terminated | |
| Z-0083-2019 | 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. | Class II | Terminated | |
| Z-0082-2019 | 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. | Class II | Terminated | |
| Z-1029-2015 | 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. | Class II | Terminated | |
| Z-0122-2013 | "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations. | 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 | Class II | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Orthosensor, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain