(86 days)
The Howmedica Ostconics Radial Ilead Prosthosis is indicated for replacement of the proximal cond of the radius in cases of theumatoid arthritis; degenerative or posplacement di ine proximation disabilities ulper initial and decreased motion at the radio-humeral andination in the mainted ulnar joint involving joint destruction and/or subluxution visible on x-ray, resilence o conservative treatment; fracture of the radial head; and symptomatic sequela after radial head resection. It is also indicated for use in revision procedures following failed radial head arthroplasty. This device is intended for cemented use only .
The Howmedica Osteonics Radial Head Prosthesis is a highly polished unar bearing surface with a distal stem. The radial head prosthesis is available in a variety of sizes ranging from 8mm to 11mm small and 9mm to 15mm medium components.
The provided text describes a 510(k) premarket notification for the Howmedica Osteonics Radial Head Prosthesis. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, a study proving device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document.
The 510(k) summary explicitly states that the substantial equivalence is "based upon equivalence in intended use, materials, design, and operational principles" to previously cleared devices. This means that the device's performance is assumed to be equivalent to the predicate devices because its fundamental characteristics are similar, and clinical trials or performance studies with defined acceptance criteria are typically not required for this type of submission.
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.