(28 days)
Identity Imprint CR KRS
The Identity Imprint CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
· Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis or osteonecrosis of the knee.
· Post traumatic loss of joint function
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
· Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartmental implants
· Revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
Identity Imprint PS KRS
The Identity Imprint PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
· Painful joint disease due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, polyarthritis or osteonecrosis of the knee.
- · Post traumatic loss of joint function
- · Moderate varus, valgus or flexion deformity
- · Failed osteotomies, hemiarthroplasties, and unicondylar, patellofemoral or bicompartental implants
- · Revision procedures provided that the anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
The Conformis Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS hereafter referred as Identity Imprint KRS Knee Replacement System (KRS) represents a family of standardized Posterior Stabilized (PS) knee implants, Cruciate Retaining (CR) knee implants, and compatible system component product offerings based on the Identity Imprint PS and CR knee replacement systems. The total knee replacement system for each size includes a femoral implant, tibial tray, polyethylene inserts, patientspecific and standardized iligs, as well as surgical instrumentation. The system also includes an iView, generated utilizing Conformis' 'Best Fit' planning software. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma.
The femoral components of the subject devices are manufactured from cobalt chromium molybdenum (CoCrMo) alloy. The tibial component includes a metal tray manufactured from titanium alloy and polyethylene inserts. The patellar components are manufactured from UHMWPE.
For user convenience, single-use, standard and patient-specific ancillary orthopedic manual surgical instruments designed for use with the selected Identity Imprint implants are provided to assist in the positioning of the total knee replacement components intraoperatively and in guiding of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
I am sorry, but the provided text (K231233 510(k) Premarket Notification) does not contain information about an AI/ML-based medical device. This document is for a Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis (a physical knee implant), not a software or AI-driven diagnostic/therapeutic tool.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, human reader performance, ground truth establishment, or training set specifics, as these concepts are not applicable to the type of device described in the document.
The document primarily focuses on:
- The device name and classification.
- Indications for Use.
- Device description (materials, components).
- Comparison to predicate devices.
- Non-clinical performance evaluation for changes like sterilization methods and shelf life extension.
There is no mention of an algorithm, image analysis, AI assistance, or any study involving human readers or ground truth for diagnostic accuracy.
§ 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.