(101 days)
The Identity Imprint 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 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, traumatoid arthritis, polyarthritis, polyarthritis or osteonecrosis of the knee.
- · Post traumatic loss of joint function.
- · Moderate varus, valgus of flexion deformity.
- · 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.
The subject device, Identity Imprint Knee Replacement System, is a new device offering of a knee replacement system including standardized implant sizes combined with standard and patient-specific ancillary surgical instrumentation. As with all Conformis Knee Replacement Systems (KRS). the Identity Imprint Knee Replacement System 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 (either CT or MR scans), a standard implant is selected that best meets the geometric and anatomic requirements of the specific patient. 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 the cutting of bone. In addition, reusable orthopedic manual surgical instruments are provided separately.
This FDA 510(k) K210191 document describes the Identity Imprint Knee Replacement System. However, the provided document does not contain any information about acceptance criteria, device performance, a specific study proving the device meets acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
The document is a premarket notification for a medical device and primarily focuses on establishing substantial equivalence to previously cleared predicate devices. It lists indications for use, technological characteristics, and mentions some non-clinical performance evaluations (cadaver/bioskills lab, femoral implant fatigue test, implant range of motion evaluation).
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and a study proving device performance as requested, as this information is not present in the provided text.
The document states:
- Non-Clinical Performance Evaluation: "The following confirmatory testing was performed: Cadaver/bioskills lab, Femoral implant fatigue test, implant range of motion evaluation."
- Conclusion: "Based on a comparison of the intended use and technological characteristics to the predicate devices and on the results of confirmatory testing it is concluded that the proposed Identity Imprint KRS is substantially equivalent."
This indicates that some testing was performed to support the substantial equivalence claim, but the details of acceptance criteria, specific performance metrics, sample sizes, ground truth, or study methodology are not disclosed in this summary document.
§ 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.