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The SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for tibiotalocalcaneal arthrodesis of the ankle following: - Post traumatic and degenerative arthritis involving both ankle and subtalar joints, - Rheumatoid arthritis, - Osteoarthritis, - Pseudoarthrosis, - Severe foot/ankle deformity, or - Instability and skeletal defects after tumor resection. These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.

The SBi Anatomic Ankle Arthrodesis Interlocking Nail System consists of implants, associated instruments, and trays. The implants are made of implantable grade titanium while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials. This Premarket Notification is to add 5.0mm Tibial Locking Screws in 20 to 24mm lengths, 5.0 mm Talar Screws with Threaded Head in 40 to 44mm lengths, and 6.0mm Calcaneal Locking Screws with Threaded Head in 50 to 68mm lengths to the system.

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 SBi Mini Rail External Fixation System is intended for fixation, compression, and distraction osteo-genesis of small bones, such as metacarpal and metatarsal. The system also includes the instruments with which to place the pins and assemble the construct. A tray is available for conveying and storing the system. The system is not intended for spinal use. The SBi Mini Rail External Fixation System is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.

The SBi Mini Rail External Fixation System consists of pins of various diameters and lengths as well as the rails and accessories with which to connect and stabilize them. The system also includes instruments to implant the pins and connect the external components. A tray is included to store and transport the set. The devices are supplied non-sterile.

The SBi Forefoot Set is indicated for bone fixation of the hand and foot following trauma or osteotomy.

The SBi Forefoot Set consists of screws and washers that provide internal fixation of bones. The devices are supplied non-sterile and are available in various sizes and configurations.

The SBI Radio-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: 1) non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The SBI Lateral Assembly Radio-Capitellar implant is intended for cemented use only.

The SBI Lateral Radio Capitellar Implant provides an alternative to hemi-arthroplasty of the proximal radial head. The implant is used for the treatment of degenerative joint disorders of the radio-capitellar joint allowing activities of daily living to be performed with no or significantly reduced pain. The radio-capitellar implant is designed to be used with the radial stem components of the rHead and rHead Recon stem implants cleared for market under 510(k) K011819 and K023604 respectively.