(101 days)
ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for single use only in skeletally mature individuals undergoing reconstruction of severely disabled and/or very painful joints.
ACTIFY™ Total Knee System and ACTIFY™ 3D Total Knee System are indicated for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems, and revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
ACTIFY™ Total Knee System is indicated for cemented use only, except for the porous femoral component which is indicated for both cemented and uncemented use.
ACTIFY™ 3D Total Knee System is indicated for cemented and uncemented use.
The ACTIFY™ 3D Total Knee System and ACTIFY™ Total Knee System implants consist of modular femoral, tibial, and patellar implants that are used as part of a complete knee system in total knee arthroplasty. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Femoral components and tibial inserts are available in posterior-stabilized (PS) and cruciate-retaining (CR) designs.
Femurs are manufactured from cobalt chromium alloy (CoCr) with a CoCr coating. Tibial inserts and patella implants are manufactured from ultrahigh molecular weight polyethylene (UHMWPE) with and without Vitamin E. ACTIFY™ 3D Total Knee tibia trays and the patella metal base are additively manufactured from titanium alloy powder per ASTM F3001. ACTIFY™ Total Knee tibia trays are manufactured from titanium alloy per ASTM F136.
The provided document describes the K240669 submission for the ACTIFY™ 3D Total Knee System and ACTIFY™ Total Knee System. This submission focuses on orthopedic implants, specifically knee joint prostheses, not AI/ML-driven medical devices. Therefore, the questions related to AI/ML acceptance criteria, study design for AI models, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, and MRMC studies are not applicable to this 510(k) summary.
The performance data section mentions mechanical testing conducted in accordance with several ASTM standards and a guidance document. These tests are standard for evaluating the mechanical integrity and performance of orthopedic implants and ensure their substantial equivalence to predicate devices, particularly regarding issues such as fatigue, shear, and tensile strength. However, specific acceptance criteria values and reported device performance from these mechanical tests are not explicitly detailed in the provided text.
The document states:
- Performance Data: Mechanical testing (tray fatigue, A-P shear, shear, and tensile) was conducted in accordance with the "Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses - Class II Special Controls Guidance Document for Industry and FDA Staff," January 16, 2003, ASTM F2083, ASTM F1800, ASTM F1044, ASTM F1147, and ASTM F1672. Performance data demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
This indicates that the device's performance was evaluated against the requirements outlined in these standards and guidance documents, and the results supported a finding of substantial equivalence. Without access to the full submission, the specific numerical acceptance criteria and the device's performance against those criteria cannot be provided.
§ 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.