(72 days)
Indicated for intractable pain resulting from traumatic arthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint. To replace functionality of the joint due to deformity or elements stated above. Intended for cemented use only.
The KMI Universal Total Wrist™ (UTW) System (either predicate or modification) consists of the following components: the radial implant, the carpal plate implant, the carpal polymer component and two bone screws. The system is offered in three sizes (small, medium, and large), with three matching polymer component sizes, which are available in varying thicknesses (standard, +1 mm, +2 mm). It 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 technique manual.
The provided text is a 510(k) summary for a medical device (Universal Total Wrist™ System), not a study report detailing acceptance criteria and performance against those criteria. Therefore, I cannot extract the requested information as it is not present in the provided document.
The document focuses on:
- Administrative information: Manufacturer, contact, device names, predicate device.
- Intended use: Medical conditions for which the device is indicated.
- System description: Components, sizes, and materials.
- Equivalence to marketed product: Claims of similarity to a predicate device.
- FDA clearance letter: Confirmation of substantial equivalence.
- Indications for Use statement: Formal statement of approved uses.
There is no mention of:
- Specific acceptance criteria (numerical thresholds for performance).
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance, expert qualifications, or adjudication methods for ground truth establishment.
- Comparative effectiveness studies (MRMC) or standalone algorithm performance.
The document describes a modification to an existing device, emphasizing its substantial equivalence to the predicate device based on material composition, intended use, operating principle, and basic design, rather than presenting a performance study with detailed acceptance criteria.
§ 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.