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REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT) The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cementless application while the glenoid baseplate (metal-back or porous) is intended for cementless application with the addition of bone screws for fixation.

The ARROW® Reverse porous glenoid base is used in total reverse shoulder prosthesis and is designed to articulate with the ARROW® Reverse shoulder system (cleared in K112193). The porous glenoid base is used with bone screws for fixation (cleared in K112193). The ARROW® Reverse porous glenoid is intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis: simple humeral prosthesis, total anatomical prosthesis and reverse prosthesis.

BePOD® 3A cannulated screws are designed for the following indications: - Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy. - Compressive osteosynthsis of fractures of several bones in the forefoot. BePOD® percutaneous cannulated screws are designed for the following indications: - Treatment of Hallux Valgus of the first metatarsal shaft (big toe) by compressive osteosynthesis, following distal and proximal metatarsal and phalangeal osteotomy. - Compressive osteosynthesis of fractures of several bones in the forefoot.

BePOD® Foot Screws includes the following elements: BePOD® 3A cannulated screws BePOD® percutaneous cannulated screws The BePOD® Foot Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

BePOD® EZ Weil screws are designed for the following indication: -Treatment of metatarsalgia on the lateral metatarsal shafts (side toes), by Weil osteosynthesis, following osteotomies carried out: - by the opened surgery (standard Weil) technique, - by the DMMO percutaneous technique (Distal Metatarsal Mini Invasive Osteotomy).

The BePOD® EZ Weil Screws are threaded titanium screws which are self-drilling and selftapping designed for use in the foot. Once completely implanted, the screw is designed so the surgeon can snap off the introducer at the snap off axis. The BePOD® EZ Weil Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

THE ARROW ANATOMICAL POROUS GLENOID, DEPENDING ON THE COMPONENTS USED, IS DESIGNED FOR: - CENTRED GLENOHUMERAL OSTEOARTHRITIS - - RHEUMATOID POLYARTHRITIS - - POST-TRAUMATIC SEQUELA WITH GLENOID INJURY - - -FRACTURES OF THE PROXIMAL HUMERUS WITH GLENOID INJURY - REVISION FOR GLENOID LOOSENING - - GLENOID BONE LOSS. WHERE BONE GRAFT IS NEEDED - - A FUNCTIONAL ROTATOR CUFF IS NECESSARY TO USE THIS DEVICE THE POROUS GLENOID BASE IS INTENDED FOR CEMENTLESS APPLICATION WITH THE ADDITION OF BONE SCREWS FOR FIXATION

The ARROW anatomical porous glenoid consists of a glenoid insert and a porous glenoid base. The porous glenoid base is used with bone screws for fixation (cleared in K112193). The glenoid inserts and the porous glenoid bases are used in total anatomical prosthesis and are designed to articulate with the ARROW anatomical shoulder system (cleared in K093599). The ARROW anatomical porous glenoid is intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis namely: simple humeral prosthesis, total anatomical prosthesis (cemented glenoid implant with 4 pegs), total anatomical prosthesis (porous glenoid implant), pending, and reverse prosthesis.

Arthrodesis cannulated screws are designed for the following indication: Arthrodesis of the metatarsal-phalangeal joint of the big toe.

BePOD® Cannulated Arthrodesis Screws includes the following elements: BePOD® Arthrodesis cannulated screws. The BePOD® Cannulated Arthrodesis Screws is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

ARROW® Humeral stems size 6 and 16, depending on the components used, are designed for: SIMPLE HUMERAL PROSTHESIS: - Fracture dislocation or complex four part fracture of the proximal humerus - Humeral head necrosis without injury to the glenoid cavity. - Extensive humeral head cartilage damage without injury to the glenoid cavity - Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant. - Rheumatoid polyarthritis with thin rotator cuff. - Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°. TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS): - Centred glenohumeral osteoarthritis with functional rotator cuff - Rheumatoid polyarthritis with functional rotator cuff - Fracture sequela, functional rotator cuff with glenoid injury. REVERSE PROSTHESIS: The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

The ARROW® Humeral stems are composed of two stems size 6 and 16. These devices are designed to articulate with ARROW® anatomical shoulder system cleared in K093599 and ARROW® reverse shoulder system cleared in K112193. ARROW® Humeral stems size 6 and 16 are intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis (and identical to those for ARROW® anatomical (K093599) and reverse shoulder system (K112193).

The CalcaNail Orthopedic Nail is intended for fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus.

The CalcaNail is orthopaedic nail for the repair of articular fractures of the calcaneus. The device consists of an orthopedic titanium 10 mm nail available in 3 lengths (45 mm, 50 mm and 55 mm) for fracture repair. The system also includes a series of 5 mm cannulated screws for fixation available in 17 lengths (24 mm - 80 mm)

The CalcaNail Orthopedic Arthrodesis Nail is intended for subtalar arthrodesis in the treatment of patients with: - Comminuted fractures of the calcaneus - Post-traumatic osteoarthritis and/or poor function resulting from calcaneal fracture sequelae - Osteoarthritis of the posterior subtalar joint, or - Valgus flatfoot deformities

The CalcaNail is orthopaedic nail for the repair of articular fractures of the calcaneus. The device consists of an orthopedic titanium 12 mm nail available in 3 lengths (65 mm, 75 mm and 85 mm) for subtalar arthrodesis. The system also includes a series of 5 mm cannulated screws for fixation available in 17 lengths (24 mm - 80 mm)

The ARROW® Reverse Shoulder long keel and short keel glenoid base is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.

The ARROW® Reverse Shoulder long keel and short keel glenoid base consist of a metal-back glenoid base, used with bone screws for fixation and assembled with previously cleared glenosphere. These components are used in total reverse prosthesis and are designed to articulate with ARROW® Reverse Shoulder System cleared in K112193. The bone fixation screws are cleared in K112193. The ARROW® Reverse Shoulder long keel and short keel glenoid base is intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis (and identical to those for ARROW® anatomical (K093599) and reverse shoulder system (K112193)).

The CoLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.

The CoLS® Fixation System is composed of the following elements: The CoLS® tendon anchoring screw, implantable device, used for the fixation of the CoLS® tendon anchoring tape to the bone. The CoLS® tendon anchoring tape, it is a non absorbable surgical suture, used for the ACL and PCL reconstruction, to which the tendon graft is attached. This implantable tendon anchoring tape is used with accessories non implantable: tape support, passing wire and scalpel blade. The CoLS® Fixation System is provided sterile and it is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.