(118 days)
The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.
General total knee arthroplasty indications include:
- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
- Post-traumatic loss of knee joint configuration and function
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
- Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
- Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
- The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament
The Unity Total Knee System is indicated for cemented, single use only.
The Corin Unity Knee System is a fixed bearing total knee replacement system that consists of a femoral component, tibial insert, tibial tray and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee System is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The Unity posterior stabilized variant is utilized when total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The Unity system patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides augments including femoral wedges, tibial wedges, a short keel extension and stem extensions.
The Unity Total Knee system was originally cleared in K113060. This submission is for the size of stem extension size to the range, a size 30mm in two available diameters 10mm and 14mm. Like the originally cleared stem extensions the 30mm has the same identical modular taper connection.
This document is a 510(k) summary for the Unity Total Knee System. It details the device's technical specifications and how it relates to predicate devices, but it does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of device performance metrics such as sensitivity, specificity, or accuracy.
The provided text describes a submission for an orthopedic implant (a knee replacement system), not a diagnostic or AI-driven medical device that would have performance metrics like those typically associated with acceptance criteria in the input request.
Therefore, I cannot extract the requested information from this document. The document primarily focuses on:
- Device Name: Unity Total Knee System
- Regulation Number: 21 CFR 888.3560
- Regulatory Class: Class II
- Product Code: JWH
- Indications for Use: Detailed for total knee arthroplasty in skeletally mature patients to increase mobility and reduce pain by replacing the damaged knee joint.
- Device Description: Discusses the components (femoral, tibial insert, tibial tray, patellar component), variants (cruciate retaining and posterior stabilized), and augments (femoral/tibial wedges, stem extensions).
- Substantial Equivalence: Claims equivalence to the predicate Corin Unity Total Knee System (K113060) based on identical intended use, indications, materials, and similar design for the new stem extension size.
- Non-Clinical Testing: Mentions fatigue endurance and fretting properties testing, concluding that the device is expected to be safe and effective.
- Clinical Testing: Explicitly states that clinical testing was not necessary to determine substantial equivalence.
In summary, the document does not contain the information required to answer your specific questions related to acceptance criteria and performance study details for an AI/diagnostic device.
§ 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.