(173 days)
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. Journey BCS Knee components are indicated for use only with cement and are single use devices.
This premarket notification seeks only to add kinematics claims for the existing Journey BCS Knee System cleared via K042515. No new total knee components being introduced as a result of this premarket notification.
The provided 510(k) summary for the Smith & Nephew JOURNEY BCS Knee System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as it pertains to AI/algorithm performance.
This document is a 510(k) premarket notification for a traditional medical device (knee implant), not an AI/ML-driven device. The focus of this submission is to add kinematics claims for an existing device, establishing substantial equivalence to a predicate device based on its physical properties and intended use, rather than algorithmic performance.
Therefore, the specific information about AI/algorithm acceptance criteria, performance studies, sample sizes, ground truth, and expert involvement for AI adjudication is not applicable and cannot be extracted from this document.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.