(28 days)
The Identity™ Imprint™ Porous Cruciate Retaining (CR) Total Knee Replacement System with Cruciate Sacrificing (CS) Insert 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, 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
The Ildentity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert is intended for uncemented use, but porous implants may be used with cement if desired by the surgeon.
The CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.
The subject device, Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert, is proposed to be a modification from Identity™ Imprint™ Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System (K223316) to be compatible with the Identity™ Imprint™ Cruciate Sacrificing (CS) Tibial Insert cleared in K230844. This submission also seeks the inclusion of the cleared AIM2Surf software (K230846) for use with the subject device. This software is used by CAD to do preliminary surface planning. No software version change is required as the surface planning is unchanged between the predicate and subject devices. The Porous Ancillary Reusable instrument tray was modified and clearance of the modification is also sought.
The subject device, Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrficing (CS) Insert, is a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. It 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.
Using patient imaging (CT scan), an Identity Imprint Porous implant is selected that best meets the geometric and anatomic requirements of the specific patient. The femoral component is manufactured from a cobalt chromium molybdenum (CoCrMo) alloy with a porous Commercially Pure titanium (CPTi) scaffold on the interior surface. The tibial tray is manufactured from a titanium alloy (Ti6Al4V-EL), with a CPTi 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 (Ti6A4V-ELI) and CPTi porous metal backing. Porous tibial, femoral, and patellar implants are designed for use without cement, but may be used with a cemented technique if necessary. The ldentity™ 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. The subject CS (cruciate sacrificing) insert option should be utilized when additional anterior-posterior constraint is desired.
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 Cruciate Sacrificing tibial insert of iPoly™ XE is offered in thicknesses of 6mm to 18mm and is the same insert as cleared with Identity™ Imprint™ Cruciate Retaining (CR) Knee Replacement System (KRS) with CS insert (K230844).
This document is a 510(k) premarket notification for a knee replacement system, which focuses on demonstrating substantial equivalence to previously cleared devices. It does not contain information about an AI/ML-based medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as these concepts are typically applied to the validation of AI/ML algorithms, not mechanical medical devices like knee implants.
The document discusses:
- Device Name: Identity™ Imprint™ Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts
- Purpose of Submission: To demonstrate compatibility of a previously cleared Cruciate Sacrificing (CS) tibial insert with an existing porous knee replacement system and to include an existing software (AIM2Surf) for preliminary bone surface planning.
- Testing Performed: Only "Tibial Micromotion Testing" is mentioned to confirm the CS insert's intended function. This is a biomechanical test, not an AI/ML performance study.
- Conclusion: The device is substantially equivalent to predicate devices based on intended use, technological characteristics, and confirmatory testing.
Since no AI/ML software performance study is described, the requested information elements (acceptance criteria for AI, sample sizes for AI test sets, AI ground truth, MRMC studies, etc.) are not present in this document.
§ 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.