(30 days)
VERASENSE is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.
For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry.
VERASENSE is sterile, for single patient use.
The VERASENSE device is an intelligent disposable tibial insert trial that measures dynamic loads in the medical and lateral compartments of the knee and wirelessly transmits the measured load data to the LinkStation MINI and LinkStation MINI Evaluation Kit with VERASENSE Software Application (VSA). The VSA provides the surgeon with a graphical and numerical presentation of the load magnitude and center of load (COL) location (weighted average) of the femoral to the tibial component in each of the medial and lateral compartments of the knee for reference only. Individual VERASENSE devices are packaged sterile, for single patient use with a shim set for thickness adjustments.
This document describes a 510(k) premarket notification for the VERASENSE for Stryker Triathlon device. It is a re-submission for a device that has previously been cleared for other implant systems (VERASENSE for Zimmer Biomet Persona, K180459). Therefore, the provided text focuses on demonstrating substantial equivalence to existing predicate devices, rather than a full de novo acceptance criteria and performance study for a novel device.
As a result, many of the typical elements of an acceptance criteria and performance study (like specific performance metrics from a clinical study, sample size for testing, expert validation process, MRMC studies) are not present in this document, as the primary goal is to show that the modified device functions similarly and safely to already-cleared devices.
However, I can extract the information that is present and highlight what is not available based on the request.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria for this 510(k) submission are not expressed as specific performance thresholds for a new clinical trial, but rather as demonstrating substantial equivalence to predicate devices. The "performance" is demonstrated by showing that the subject device meets the same specifications and standards as the predicate devices, despite minor technological differences.
Table of Acceptance Criteria (vs. Predicate Device) and Reported Device Performance:
| Feature/Criteria | Predicate Device (K180459) | Subject Device (VERASENSE for Stryker Triathlon) | Reported Performance / Substantial Equivalence |
|---|---|---|---|
| Classification | 21 CFR 882.4560 (Class II, Stereotaxic Instrument) | 21 CFR 882.4560 (Class II, Stereotaxic Instrument) | Substantially Equivalent |
| Product Code | ONN | ONN | Substantially Equivalent |
| Intended Use | Dynamic knee balancing during TKA | Dynamic knee balancing during TKA | Substantially Equivalent (VERASENSE provides a means for orthopedic surgeons to dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA)). |
| Indications for Use | Same as Subject Device. | Indicated for any medical condition in which primary or revision TKA would be indicated, as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. Sterile, single patient use. | Substantially Equivalent |
| Environment | Hospital | Hospital | Substantially Equivalent |
| Electrical Safety | IEC 60601-1 | IEC 60601-1 | Substantially Equivalent |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | IEC 60601-1-2 | Substantially Equivalent |
| Usability | IEC 62366 | IEC 62366 | Substantially Equivalent |
| Load Range and Accuracy | 5-40 lbf |
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).