(266 days)
The Identity Imprint Porous Cruciate Retaining Total 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 a unicondylar, patellofemoral or bicompartmental prosthesis.
The Indications for Use include:
- · Painful joint disease due to osteoarthritis, traumatoid 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.
The Identity Imprint Porous Cruciate Retaining Total Knee Replacement System is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.
The subject device, Identity Imprint Porous Total Knee Replacement System (including Identity Imprint Porous Cruciate Retaining Total Knee Replacement System) is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with other Conformis Knee Replacement Systems (KRS), the Identity Imprint Porous Knee Replacement System (KRS) is semi-constrained knee implants which consist of a femoral, tibial, and/or patellar components. The products are intended for treatment of severe pain and/or disability of the knee damaged by osteoarthritis or trauma. The device is intended for cementless fixation however the surgeon may also use cement.
Using patient imaging (CT scans), an Identity Imprint set of implants is selected. The femoral component is manufactured from a cobalt chromium molybdenum (CoCrMo) alloy with a porous Commercially Pure titanium (CP Ti) scaffold on the interior surface. The tibial tray is manufactured from alloy (Ti6Al4V-ELI), with a CP Ti porous scaffold on the interior surface. The tibial insert component is manufactured from highly cross-linked ultra-high molecular weight Vitamin-E enriched polyethylene (iPoly XE). The patellar component is manufactured and offered in ultra-high molecular weight polyethylene (iPoly) with a solid titanium alloy (Ti6Al4V-EL) and CPTi porous metal backing. The layer of CPTi scaffolding bonded to the femoral, tibial, and patellar implants provides a surface for porous ingrowth, promoting biological fixation and obviating the need for bone cement to achieve fixation. Porous tibial, femoral, and patellar implants are designed for use without cement, but may be used with a cemented technique if necessary.
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. These guides are pre-navigated to fit the contours of the patient's femoral and tibial anatomies and to facilitate a simpler surgical technique. The ilig instrument set is designed for single-use, and manufactured from biocompatible nylon material and supplied sterile along with the implants. In addition, reusable orthopedic manual surgical instruments are provided separately.
The device is intended to be used in a sterile field by trained orthopedic surgeons (Use Environment).
The Imprint Porous Knee Replacement System is compatible with cemented Identity Imprint CR KRS implants. Cemented and uncemented implants may be used together for a hybrid technique.
Unfortunately, the provided text does not contain the information needed to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.
The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device (Identity Imprint Porous Total Knee Replacement System). While it discusses non-clinical performance evaluation, it outlines the types of testing performed for substantial equivalence to a predicate device, rather than specifying:
- Quantitative acceptance criteria for each test (e.g., "Fatigue life shall be X cycles without failure").
- Reported device performance against those specific criteria.
- Details on a human-in-the-loop study (MRMC) or a standalone algorithm performance study, as these typically relate to AI/software device performance, which is not the primary focus of this submission for a knee replacement system that involves physical implants and surgical instruments.
- Information regarding sample sizes for training/test sets for AI models, expert qualifications, adjudication methods, or ground truth establishment in the context of an AI/software device. These are generally not applicable to the clearance of a mechanical orthopedic implant system.
The "Non-Clinical Performance Evaluation" section mentions:
- Femoral and Tibial Fatigue testing
- Patella Shear Testing
- Patella Tensile Testing
- Porous Bond Shear and Tensile Strength
- Tibial Micromotion
- Patella Durability/Wear Thru Testing
- MRI Compatibility Testing
- Cadaveric Testing
However, it does not provide the specific acceptance criteria or the numerical results of these tests, which would be found in the full 510(k) submission, not typically in the publicly available summary letter.
Therefore, I cannot fulfill the request based on the provided text.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.