(87 days)
The KMI Universal Total Wrist™ System is indicated for intractable pain resulting from traumatic arthritis, osteo arthritis, theumatoid arthritis, trauma induced osteo arthritis of the radial / Carpal joint. To replace functionality of the joint due to deformity or elements stated above.
The KM1 will be offered in three sizes (small, medium, and large) with the poly bearing implant also offered in three sizes to match the carpal plate implants. The Universal total Wrist implant is constructed of materials that have a long clinical history of proven acceptance and performance. This system is intended for use with cement and will be promoted as such in the UTW surgical protocol
The provided text describes a medical device, the Universal Total Wrist™ System, and its regulatory submission to the FDA. However, it does not contain information about acceptance criteria for the device's performance in a study, nor does it detail any specific study that proves the device meets such criteria.
The document focuses on:
- Regulatory Information: Company details, classification, and substantial equivalence to other existing devices.
- Device Description: Materials used (meeting ASTM standards), sizes, indication for use, and sterilization methods.
- Performance Standards: It explicitly states, "No performance standards applicable to semi-constrained wrist implant have been established by the FDA." It then mentions that the materials used (titanium alloy, CrCoMo) meet chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM).
- Summary: Highlights the long clinical history of similar wrist implant systems and the understanding of their uses, indications, and limitations.
Therefore, I cannot provide the requested table or details about a study demonstrating acceptance criteria because this information is not present in the provided text.
§ 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist 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 either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.