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The Arthrosurface Total Wrist Arthroplasty System is indicated for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis. The device is a single-use implant intended to be used with bone cement.

The Arthrosurface Total Wrist Arthroplasty (TWA) System is a modular joint restoration system that consists of both a radial implant assembly and carpal implant assembly. The radial implant assembly is comprised of a metallic stemmed tray component and Ultra-High-Molecular-Weight-Polyethylene (UHMWPE) articular component. The carpal implant assembly consists of a taper post component, a carpal plate, an articular component and two auxiliary bone screw components, all of which are metallic. The system is designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint.

Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement or without bone cement.

The Arthrosurface MTP implant incorporates an articular resurfacing component and a taper post component that mate together via a morse taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface. Per K132496, the MTP can be used in conjunction with the Arthrosurface Proximal Phalanx Implant as a Total Toe option. K132496 also cleared the most recent version of the mating articular component. Fixation components are being included in the system that contain an additional ring of material intended to improve stabilization in a first metatarsal that presents with a distal bone void. The articulating component and taper configuration are unchanged. The phalangeal implant is unchanged.

Intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The Patello-Femoral Wave《hung Arthroplasty System is a line extension to the Sponsor's previously cleared and commercially marketed HemiCAP™ Patello-Femoral Resurfacing System. The line extension consists of a larger femoral component for increased coverage of the trochlear groove. The additional sizes will address larger defects of the superior aspect of the trochlea and provide greater coverage superiorly. The system also includes larger mating UHMWPE patella components as described within. The larger PF Kahuna trochlear Patello-Femoral Wave"«ከ«ባ articular component is designed to mate with the currently marketed Arthrosurface Patello-Femoral fixation component. The majority of the implantation technique steps are the same. The PF Kahuna trochlear component is implanted using the same Instrumentation Set as with the HemiCAP™ Patello-Femoral Resurfacing System, with the addition of a reaming operation to create the superior ream. The reamers, associated implant trials etc. are contained within an adjunct Patello-Femoral WaveKahuna Instrumentation Kit.

For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck and glenoid be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used for hemiarthroplasty or in conjunction with the Arthrosurface glenoid component for total shoulder arthroplasty. Both humeral and glenoid components of the OVOMotion™ Shoulder Arthroplasty System are intended for cemented use only.

The OVOMotion™ Humeral prosthesis incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface. The Arthrosurface OVOMotion™ Shoulder Arthroplasty System is intended as hemiarthroplasty or in conjunction with Sponsor's previously cleared and commercially marketed glenoid prosthesis (K091196) to repair and replace a shoulder joint when both articular surfaces of the joint are affected. Humeral articular components are manufactured from CoCrMo and mate with corresponding Ti fixation component. Glenoid components are made from Ultra High Molecular Weight Polyethylene (UHMWPE). Both humeral and glenoid components are available in multiple sizes and curvatures and are intended to be implanted using bone cement.

The Arthrosurface Bone Screws (2.0-3.0 mm solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist. The Arthrosurface Bone Screws (3.5 mm and larger, solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, shoulder, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula.

The Arthrosurface Bone Screws have diameters ranging from 2.0 mm to 4.0 mm and lengths ranging from 8 mm to 50 mm. The screws are either partially or fully threaded, solid or cannulated, self-tapping or self-drilling and are manufactured from implant grade stainless steel or titanium alloy. Depending on their size, these bone screws are intended to be used for different indications for use.

Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.

The ToeMATE® Hammertoe Correction System consists of two intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery. The implants are offered in three size options, x-small, small and large. The taper lock pin provides a press fit connection between the two screws with light contact pressure and is available in straight and angled configurations. The implant components are manufactured using implant grade titanium alloy and cobalt-chrome alloy.

Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

The AlignMATE™ Lapidus Arthrodesis System consists of bone plates and bone screws (locking, non-locking and interfragmentary), which are intended to be used for surgical fusion or arthrodesis between two bone segments (ex. 1st metatarsalcuneiform fusion as in a Lapidus procedure). All implant components are manufactured from implant grade titanium alloy.

Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

The Arthrosurface Bone Screws have a diameter of 2.0/2.7 mm and are made available in lengths varying from 8 mm to 24 mm with 2 mm increments. The bone screws have a snap-off feature and are designed to work with a powered wire driver, and are manufactured from implant grade stainless steel or titanium allov.

Hemi-Arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

The HemiCAP® MTP Resurfacing Hemi-Arthroplasty System-Phalangeal HemiCAP® incorporates an articular resurfacing component and a cancellous taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface. The enclosed phalangeal base HemiCAP® implant is intended for hemiarthroplasty only. Do not use in conjunction with metallic metatarsal implant. The present device modification includes the addition of modified phalangeal base (concave) implants and a corresponding taper post to the existing system.

Indicated for use as a partial replacement of wrist joint(s) disabled by pain, deformity and/or limited motion caused by: - Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis and avascular necrosis - Rheumatoid arthritis . - Revision where other devices or treatments have failed ● - Scapholunate Advanced Collapse (SLAC) and other functional deformities ● - Trauma, including fractures of the carpal bones ● The device is a single use implant intended to be used with bone cement.

The Arthrosurface HemiCAP® Wrist Hemiarthroplasty System consists of a contoured articular implant designed to articulate with the natural radius bone, a taper post and set of instruments used for implant site preparation and delivery. The resurfacing components are manufactured using implant grade cobalt-chrome alloy and will be offered in two diameters, and four articular radii. The taper post is manufactured using implant grade titanium alloy and is offered in one fixed size designed to work with all resurfacing implants.