Orthosensor
FDA Regulatory Profile
Orthosensor appears in FDA public data with 8 recalls, 8 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0084-2019, Class II) was initiated on July 12, 2018. Its most recent 510(k) clearance was granted on August 25, 2020.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 8
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0084-2019 | Class II | OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L. | July 12, 2018 |
| Z-0085-2019 | Class II | OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R. | July 12, 2018 |
| Z-0087-2019 | Class II | OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R. | July 12, 2018 |
| Z-0086-2019 | Class II | OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L. | July 12, 2018 |
| Z-0082-2019 | Class II | OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L. | July 12, 2018 |
| Z-0083-2019 | Class II | OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R. | July 12, 2018 |
| Z-1029-2015 | Class II | Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynami | December 5, 2014 |
| Z-0122-2013 | Class II | "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***S | February 4, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200587 | VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation | August 25, 2020 |
| K200665 | VERASENSE for Stryker Triathlon | April 12, 2020 |
| K193580 | VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 | April 1, 2020 |
| K180459 | VERASENSE for Zimmer Biomet Persona | June 7, 2018 |
| K150372 | VERASENSE Knee System | April 15, 2016 |
| K131767 | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM | November 8, 2013 |
| K130380 | ORTHOSENSOR KNEE BALANCER | June 13, 2013 |
| K090474 | ORTHOREX INTRA-OPERATIVE LOAD SENSOR | October 19, 2009 |