Search Results

The Intraosseous Fixation System is indicated to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges.

The Intraosseous Fixation System consists of various size implants to stabilize and aid in the fixation of fracture, fusions, and osteotomies of the phalanges. The implants are offered in different lengths and diameters. All implants are manufactured from implant grade titanium alloy or PEEK.

The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.

The MaxLock Extreme System™ is indicated for the following: •The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle. • The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle. • The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients. • The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

The MaxLock Extreme™ System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy or PEEK.

The OrthoHelixTM Syndesmosis Fixation Devices are indicated as adjunct fixation in repair involving metaphyseal and periarticular small bone fragments and surrounding soft-tissues where screws are not indicated and as an adjunct in external and intramedullary fixation systems involving plates and rods with fracture braces and casting. Specifically, the Syndesmosis Fixation Devices are intended to provide fixation during the healing process following a syndesmotic trauma such as fixation of ankle syndesmosis disruptions in connection with Weber B and C ankle fractures, as well as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The OrthoHelixTM Syndesmosis Fixation Devices are implant assembly constructs of metallic buttons and non-absorbable suture intended to aid in the reconstruction of bones in the hand, wrist, elbow, shoulder, foot, and ankle, particularly in the reconstruction of the syndesmosis joint in the ankle and the AC joint in the shoulder. The syndesmosis devices are offered in different configurations, one to be used with and one to be used without a plate. All metallic implant components are manufactured from titanium alloy. All suture implant components are UHMWPE non-absorbable suture.

The MaxLock Extreme System is indicated for the following: • The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle. • The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle. • The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients. • The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

The MaxLock Extreme™ System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium allov or PEEK.

The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.

The MaxTorque™ Screw System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments. The MaxTorque™ Screw System is indicated for use in long and small bone fracture, fusion, and osteotomy fixation, which includes but is not limited to the following: - Fractures of the tarsal and metatarsals - Fractures of the olecranon, distal humerus - Fractures of the radius and ulna - Patellar fractures - Distal tibia and pilon fractures - Fractures of the fibula, medial malleolus, os calcis - Tarso-metatarsal and metatarsal-phalangeal Arthrodesis - Metatarsal and Phalangeal osteotomies - Osteochondritis dissecans - Ligament fixation - Other small fragment, cancellous bone fractures and osteotomies

The submission is a modification to the MaxTorque™ Screw System to add additional screw styles and lengths. No modifications were made to the existing implants. The MaxTorque™ Screw System consists of screws of various diameters, lengths and thread configurations. The system also includes correspondingly sized washers, the use of which is optional.

The MaxLock Extreme System is indicated for the following: •The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation and fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle. • The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle. •The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients. • The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

The MaxLock Extreme® System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy or PEEK

The MaxLock Extreme System is indicated for the following: - •The MaxLock Extreme Universal Module is indicated for use in adult or pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include internal fixation of the tibia, fibula, femur, humerus, ulna, radius, and bones in the hand, wrist, foot and ankle. - · The MaxLock Extreme Clavicle Module is indicated for fractures, fusions and osteotomies of the clavicle and bones in the hand, wrist, foot and ankle. - ·The MaxLock Extreme Foot Module is indicated for fractures, fusions and osteotomies of bones in the hand, wrist, foot and ankle in pediatric and adult patients. - ·The MaxLock Extreme Distal Radius Module is indicated for fractures and osteotomies of the distal radius in adult patients.

The MaxLock Extreme® System consists of various size plates and screws used to stabilize and aid in the fusion or repair of fractured bones and bone fragments. The plates are offered in different lengths and sizes. The screws are offered in different diameters and lengths. All implantable components are manufactured from implant grade titanium alloy or PEEK

The Mini MaxLock Extreme® Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.

The submission is a modification to the Mini MaxLock Extreme® Plating System to add additional plate styles. No modifications were made to the existing plates or screws