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Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

• · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed; and
• · Treatment of fractures that are unmanageable using other techniques.

Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.

The subject of this Special 510(k) is the Journey II Unicompartmental Knee System (Journey II UK). The subject device is a unicondylar femoral and tibial implant set for treatment of unicompartmental osteoarthritis. The device is intended for appropriate unicondylar, medial or lateral, ACL and PCL preserving joint treatment (partial knee replacement).

Components of this premarket notification consist of a femoral implant, tibia baseplate, modular articular insert, and requisite US Class II surgical instrumentation required will consist of femoral instruments used to make appropriate resections to prepare the femur for said implants and tibial instruments used to make a planar resection and implant preparation of the proximal tibia.

The Journey II UK is a line extension of the Smith & Nephew Unicompartmental Knee line, incorporating previously cleared Smith & Nephew products. It contains design aspects of the existing Journey II Uni Tibial Baseplate and Inserts (S.E. K152315), the Journey Uni (S.E. K102069), and the ZUK (S.E. K160738).

Femoral components are manufactured from Oxinium (Zr-2.5Nb), and feature ten sizes each in left medial/right lateral and right medial/left lateral side (hand) configurations.

Tibial baseplates are manufactured from Titanium alloy (Ti-6Al-4V). They are available in:

• . Ten sizes of implant with a medial primary / lateral secondary use offered in both left and right handedness (listed henceforth as "medial primary"), and
• . Eight sizes of implant with a lateral primary / medial secondary use offered in both left and right handedness (listed henceforth as "lateral primary").

Each are expected to be used in its primarily listed compartment most often, but are designed for use in either medial or lateral compartments.

Modular articular implants are manufactured from cross-linked polyethylene (XLPE) and are available in medial and lateral configurations for use with corresponding baseplate. They are symmetric for use in either right or left hand.

The provided text is a 510(k) summary for the Journey II Unicompartmental Knee System. This document is a premarket notification for a medical device and does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. Instead, it details mechanical verification testing for an orthopedic implant.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study from this document, as it pertains to a different type of medical device and regulatory submission.

Specifically, the document states: "Clinical data was not needed to support the safety and effectiveness of the subject device." This indicates that no human clinical study, which would typically involve performance metrics and acceptance criteria as outlined in your request, was conducted. The device's safety and effectiveness were established through mechanical testing and comparison to predicate devices, not through a study involving human subjects or AI performance.

To reiterate, the requested information elements (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set) are not applicable to the content of this 510(k) summary for a knee implant.

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