(64 days)
The Sulzer Orthopedics Fluted Stems are intended for cemented use in the following diagnostic indications:
- Patient conditions, including but not limited to, inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis).
- Correctable valgus-varus deformity and moderate flexion contracture.
- Those patients with failed previous surgery where pain, deformity, or dysfunction persist.
- Revision of previously failed knee arthroplasty.
The Sulzer Orthopedics Fluted Stems, manufactured from forged or wrought Titanium alloy (ASTM F620 or F136, respectively), fit into the intermedullary canal of either the femur or tibia and provide additional implant stability. The stems are available in straight or offset versions in a variety of lengths and diameters. The flutes ensure rotational stability. The stems have been designed with male taper mechanisms which are capable of mating with the stem boss of the components. Rotational stability is afforded by the key feature at the base of the taper. Further assurance of stem-taper connection to the maing component is provided by a small set screw. This device is intended for use with the following devices:
- Natural-Knee II Revision Femoral Component
- Natural-Knee II Constrained Femoral Component
- Apollo Revision/Constrained Knee Femoral Component and Tibial Baseplate
This document is a 510(k) summary for a medical device (Sulzer Orthopedics Fluted Stems) seeking clearance from the FDA. It declares substantial equivalence to existing devices rather than presenting a performance study with acceptance criteria.
Therefore, the requested information elements related to acceptance criteria, device performance, study design, and ground truth are not present in the provided text. This type of submission (510(k)) focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing it has the same technological characteristics and intended use, rather than through extensive clinical trials with specific performance endpoints.
The document explicitly states: "We have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic 'bone cement.'"
Since no performance study designed to meet specific acceptance criteria is described, the requested table and details about sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this text.
§ 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.