Search Results

Indications for use when used with a hemi-elbow implant:

The SBi rHead Radial Head is indicated for use in replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:

• . Joint destruction or subluxation visible on x-ray
• Resistance to conservative treatment .

Primary replacement after fracture of the radial head

• . Symptomatic sequelae after radial head resection
• Revision following failed radial head arthroplasty .

Indications for use when used with a uni-elbow implant:

The SBi Radial-Capitellar Implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions:

• Non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis
• . Inflammatory degenerative joint disease including rheumatoid arthritis
• Correction of functional deformity .
• Revision procedures where other treatments and devices have failed and .
• . Treatment of fractures that are unmanageable using other technologies

The SBirHead, tHead Lateral, and rHead Recon prostheses are implants that are intended to replace the proximal end of the radius. The implants consist of two (2) parts, the head and a stem, which fit together. The rHead™ Standard is designed with a Morse taper coupling mechanism to firmly attach the head onto the stem. The rHead™ RECON is designed with a "ball/socket" (bipolar) coupling mechanism between the head and stem which adds an element of alignment flexibility. The rHead™ Lateral is designed using a dovetail coupling mechanism.

The stem is made from a Cobalt Chrome alloy (CoCrMo) with or without a powder titanium (Ti) coating. The radial stem geometry is designed to anatomically fit within the intramedullary canal. The intramedullary surfaces of the stem are roughened to assist in optimal fixation. A version of the stem may be plasma sprayed with a powder titanium coating to further assist in optimal fixation. The extended stem provides additional fixations where excess bone loss due to trauma has occurred. Stems are for cemented or uncemented use when used with the rHead heads.

Each component is supplied in various sizes to support the differences in human anatomies. Each implant can be used in either the right or left arm and the heads and stems are modular.

rHead Radial Head Extended Stems are made from a Cobalt Chrome alloy (CoCrMo) with or without a powder titanium (Ti) coating. rHead Radial Head Extended Stems are configured to fit the rHead, rHead Recon, and rHead Lateral heads as well as rHead, rHead Recon, and rHead Lateral heads that fit the Radial Capitellum radial head implants.

The rHead, rHead Lateral, and rHead Recon prostheses are used with trials and surgical instruments including a sterilization tray.

The implants are intended for single use only.

The provided text is a 510(k) Premarket Notification Summary for the SBi rHead™ Radial Head Extended Stems. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's description, intended use, and materials.

However, this document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table and study details. The document states that "Documentation is provided which demonstrated the SBi rHead™ Radial Head Extended Stems to be substantially equivalent to other legally marketed SBi devices," but it does not elaborate on what that documentation entails in terms of performance studies.

Based on the provided text, the answer to your request is that the document does not contain the information needed to describe acceptance criteria and associated performance study details.

Ask a specific question about this device