Verasense
VERASENSE is an intraoperative knee system for primary or revision total knee arthroplasty, with an instrumented trial tibial insert containing an array of load sensors. After insertion…
VERASENSE is an intraoperative knee system for primary or revision total knee arthroplasty, with an instrumented trial tibial insert containing an array of load sensors.
After insertion between the tibia and femur, its sensors measure forces on the insert and angular position information such as alignment and slope positioning.
Stated Use
The filing describes its use as a tool to adjust the femoral knee implant to reduce instability from flexion gap asymmetry. It is sterile and for single patient use, and the summary lists compatible knee implant systems.
1manufacturer
140catalogue numbers in this listing
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) | K150372 |
| Record published | 2017-04-21 |
| Record revised | 2023-05-03 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 47 to 106 KiloPascal; Handling environment humidity 30 to 100 % RH; Handling environment temperature 15 to 37 °C; Storage environment atmospheric pressure 36 to 106 KiloPascal; Storage environment humidity 10 to 80 % RH; Storage environment temperature 0 to 50 °C |
| Distribution end date | 2023-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VERASENSE for Smith & Nephew Journey II CR 1-2 Right | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 1-2 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 3-4 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 7-8 Right | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 1-2 Left | Withdrawn | |
| VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 3-4 | Withdrawn | |
| VERASENSE for Stryker Triathlon size 7 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 5-6 Left | Withdrawn | |
| VERASENSE for Zimmer NexGen PS C-D/3-4 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 1-2 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 7-8 Right | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 5-6 | Withdrawn | |
| VERASENSE for Zimmer NexGen PS C-D/3-4 | Withdrawn | |
| VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right | Withdrawn | |
| VERASENSE for Stryker Triathlon size 6 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 5-6 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 3-4 Right | Withdrawn | |
| VERASENSE for Zimmer NexGen CR C-H/3-4 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 5-6 Left | Withdrawn | |
| VERASENSE for Biomet Vanguard CR size 79/83 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 1-2 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 1-2 | Withdrawn | |
| VERASENSE for Zimmer NexGen CR C-H/3-4 | Withdrawn | |
| VERASENSE for Stryker Triathlon size 5 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 5-6 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 3-4 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 5-6 Right | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 1-2 Right | Withdrawn | |
| VERASENSE for Biomet Vanguard PS size 79/83 | Withdrawn | |
| VERASENSE for Stryker Triathlon size 5 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 1-2 Left | Withdrawn | |
| VERASENSE for Stryker Triathlon size 7 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 7-8 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 1-2 Right | Withdrawn | |
| VERASENSE for Stryker Triathlon size 6 | Withdrawn | |
| VERASENSE for Zimmer NexGen PS C-D/3-4 | Withdrawn | |
| VERASENSE for Biomet Vanguard CR size 79/83 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 3-4 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 5-6 Right | Withdrawn | |
| VERASENSE for Biomet Vanguard CR size 71/75 | Withdrawn | |
| VERASENSE for Biomet Vanguard PS size 63/67 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 5-6 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 3-4 | Withdrawn | |
| VERASENSE for Stryker Triathlon size 5 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 3-4 Right | Withdrawn | |
| VERASENSE for Zimmer NexGen CR C-H/5-6 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 5-6 Left | Withdrawn | |
| VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 5-6 Right | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 5-6 Left | Withdrawn | |
| VERASENSE for Zimmer NexGen PS E-F/5-6 | Withdrawn | |
| VERASENSE for Stryker Triathlon size 7 | Withdrawn | |
| VERASENSE for Biomet Vanguard PS size 79/83 | Withdrawn | |
| VERASENSE for Stryker Triathlon size 2 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 5-6 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 3-4 Left | Withdrawn | |
| VERASENSE for Zimmer NexGen CR C-H/7-10 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 1-2 Right | Withdrawn | |
| VERASENSE for Stryker Triathlon size 2 | Withdrawn | |
| VERASENSE for Zimmer NexGen CR C-H/7-10 | Withdrawn | |
| VERASENSE for Biomet Vanguard PS size 63/67 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 5-6 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 3-4 Right | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 7-8 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 5-6 Right | Withdrawn | |
| VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left | Withdrawn | |
| VERASENSE for Stryker Triathlon size 3 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 7-8 Right | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 7-8 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 5-6 Right | Withdrawn | |
| VERASENSE for Biomet Vanguard CR size 63/67 | Withdrawn | |
| VERASENSE for Biomet Vanguard CR size 79/83 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 7-8 Right | Withdrawn | |
| VERASENSE for Biomet Vanguard CR size 63/67 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 7-8 Right | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 5-6 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 7-8 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 7-8 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 1-2 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 1-2 | Withdrawn | |
| VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left | Withdrawn | |
| VERASENSE for Stryker Triathlon size 4 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 3-4 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 7-8 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 1-2 Right | Withdrawn | |
| VERASENSE for Zimmer NexGen CR C-H/5-6 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 1-2 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 7-8 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 7-8 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 1-2 | Withdrawn | |
| VERASENSE for Stryker Triathlon size 3 | Withdrawn | |
| VERASENSE for Biomet Vanguard PS size 71/75 | Withdrawn | |
| VERASENSE for Zimmer NexGen CR C-H/7-10 | Withdrawn | |
| VERASENSE for Zimmer NexGen PS E-F/3-4 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 5-6 | Withdrawn | |
| VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 7-8 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 1-2 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 3-4 Right | Withdrawn | |
| VERASENSE for Zimmer NexGen PS E-F/3-4 | Withdrawn | |
| VERASENSE for Zimmer NexGen PS E-F/5-6 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 3-4 Left | Withdrawn | |
| VERASENSE for Stryker Triathlon size 2 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 3-4 Right | Withdrawn | |
| VERASENSE for Stryker Triathlon size 4 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 7-8 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 3-4 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 1-2 Right | Withdrawn | |
| VERASENSE for Biomet Vanguard CR size 71/75 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 1-2 | Withdrawn | |
| VERASENSE for Biomet Vanguard CR size 71/75 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 1-2 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 1-2 | Withdrawn | |
| VERASENSE for Biomet Vanguard PS size 71/75 | Withdrawn | |
| VERASENSE for Zimmer NexGen CR C-H/3-4 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 3-4 Left | Withdrawn | |
| VERASENSE for Biomet Vanguard PS size 71/75 | Withdrawn | |
| VERASENSE for Biomet Vanguard PS size 63/67 | Withdrawn | |
| VERASENSE for Stryker Triathlon size 4 | Withdrawn | |
| VERASENSE for Zimmer NexGen PS E-F/5-6 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 5-6 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 5-6 | Withdrawn | |
| VERASENSE for Stryker Triathlon size 3 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 7-8 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion CR size 3-4 | Withdrawn | |
| VERASENSE for Zimmer NexGen CR C-H/5-6 | Withdrawn | |
| VERASENSE for Biomet Vanguard PS size 79/83 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 7-8 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 3-4 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 3-4 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II BCS 3-4 Right | Withdrawn | |
| VERASENSE for Biomet Vanguard CR size 63/67 | Withdrawn | |
| VERASENSE for Smith & Nephew Legion PS size 7-8 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 7-8 Right | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 7-8 Left | Withdrawn | |
| VERASENSE for Stryker Triathlon size 6 | Withdrawn | |
| VERASENSE for Zimmer NexGen PS E-F/3-4 | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 3-4 Left | Withdrawn | |
| VERASENSE for Smith & Nephew Journey II CR 5-6 Right | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Trolly | 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 Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orthosensor, Inc. | UDI-DI | 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 |
| Orthosensor, Inc. | UDI-DI | 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 |
| Orthosensor, Inc. | UDI-DI | 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 |
| Orthosensor, Inc. | UDI-DI | 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 |
| Orthosensor, Inc. | UDI-DI | 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 |
| Orthosensor, Inc. | UDI-DI | 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 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 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.