Verasense Software Application
Catalogue number 5.6.1.138, listed by Orthosensor, Inc., United States, under Intraoperative Orthopedic Joint Assessment Aid. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
8510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Immetech Industrial Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Orthosensor, Inc., United States |
|---|---|
| FDA product code | ONN |
| Device type | Intraoperative Orthopedic Joint Assessment Aid |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| 510(k) | K200665 |
| Record published | 2022-08-24 |
| Record revised | 2023-07-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Distribution end date | 2023-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5.6.1.138 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Verasense | Orthosensor, Inc. | 140 |
| Lantern | OrthAlign, Inc. | 24 |
| LinkStation Mini | Orthosensor, Inc. | 8 |
| Linkstation Mini Evaluation Kit | Orthosensor, Inc. | 8 |
| Verasense for Stryker Triathlon | Orthosensor, Inc. | 6 |
| Verasense for Zimmer Biomet Persona | Orthosensor, Inc. | 6 |
| Lantern ASC | OrthAlign, Inc. | 4 |
| eLIBRA® | Synvasive Technology, Inc. | 2 |
| Verasense for Exactech Equinoxe Reverse | Orthosensor, Inc. | 2 |
| Lantern Surgical Assistant | OrthAlign, Inc. | 1 |
| Dongle Assembly | Eventum Orthopaedics Ltd | 1 |
| Quadsense Pro | Eventum Orthopaedics Ltd | 1 |
Showing 12 of 15. All products under Intraoperative Orthopedic Joint Assessment Aid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200587 | 2020-08-25 |
| K200665 | 2020-04-12 |
| K193580 | 2020-04-01 |
| K180459 | 2018-06-07 |
| K150372 | 2016-04-15 |
| K131767 | 2013-11-08 |
| K130380 | 2013-06-13 |
| K090474 | 2009-10-19 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-07-12 | Class II | Under Investigation by firm | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | 56 devices | 2019-06-27 |
| 2018-07-12 | Class II | Under Investigation by firm | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | 37 devices | 2019-06-27 |
| 2018-07-12 | Class II | Under Investigation by firm | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | 84 devices | 2019-06-27 |
| 2018-07-12 | Class II | Under Investigation by firm | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | 36 devices | 2019-06-27 |
| 2018-07-12 | Class II | Under Investigation by firm | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | 41 devices | 2019-06-27 |
| 2018-07-12 | Class II | Under Investigation by firm | Some sensors were reported to have fluid inside the posterior lateral corner post-surgery. | 68 devices | 2019-06-27 |
| 2014-12-05 | Class II | Under Investigation by firm | Presence of one inoperable (dead) sensor pad. | 22 devices | 2015-03-13 |
| 2012-02-04 | Class II | Software design | 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 | 9 | 2012-12-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.