(37 days)
The Journey Unicondylar Femoral Implant components are indicated for restoring either compartment of a knee that has been affected by the following:
- Noninflammatory 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.
The Journey Unicondylar Femoral Implant components are single use only and are intended for implantation only with bone cement.
The Journey Unicondylar Femoral Implant components will consist of various size and hand femoral implants for medial and lateral tibiofemoral compartment replacement. The femoral implants are anatomically shaped and are available in right and left, medial-lateral hand configurations (LL/RM and RL/LM). The femoral implants are offered in sizes 1-7.
I am sorry, but the provided text is a 510(k) summary for a medical device (Smith & Nephew Journey Unicondylar Femoral Implants). This document does not contain information about acceptance criteria, device performance metrics, or details of a study involving AI, human readers, or ground truth establishment.
The document primarily focuses on:
- Intended Use: What the device is for.
- Device Description: What the device is made of and its types.
- Substantial Equivalence: Comparing the new device to previously approved devices.
- Regulatory Information: FDA approval letter, classification, and contact information.
Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about acceptance criteria, study details, sample sizes, or expert qualifications from this document.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.