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The Shotel Ankle Arthrodesis Nail System is intended for the following: - Charcot Foot - Avascular necrosis of the talus - Failed total ankle arthroplasty - Trauma (malunited tibial pilon fracture) - Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease - Revision ankle arthrodesis - Neuroarthropathy - Rheumatoid arthritis - Osteoarthritis - Pseudoarthrosis - Post-Traumatic arthrosis - Previously infected arthrosis - Severe end stage degenerative arthritis - Severe defects after tumor resection - Pantalar arthrodesis

The Shotel Ankle Arthrodesis Nail System is an implantable intramedullary system of fusion nails, bone screws, a nail cap and a set of instruments for primary ankle fusion. The curved fusion nail has 6 screw holes that can accommodate up to 6 bone screws and is available in seven (7) diameters in two configurations, left and right. The four (4) distal cross locking holes provide the surgeon with either a static or dynamic cross locking hole in alternative 90 degree orientation configurations. The 5mm fixation bone screws are offered in 27 lengths and the nail caps are available in two configurations; standard nail cap length and a plus 5 mm nail cap length affording the surgeon the ability to slightly adjust the final nail assembly length. All three implant components are manufactured from titanium Ti-6Al-4V and are single use only. Components are offered sterile and non-sterile.

The intended use of the BioPro Foot Plating Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following bone plate categories: I. Forefoot System: The BioPro Forefoot Plating System is Indicated for Use in fixation of small bones and small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies , nonunions, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient. The Forefoot System is not for Spinal Use. II. Mid & Hindfoot System: The BioPro Mid & Hindfoot Plating System is Indicated for Use in fixation of medium/large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, malunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient. The Mid & Hindfoot System is not for Spinal Use. III. Ankle Fracture System: The BioPro Ankle Fracture System is Indicated for Use in: 1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, perarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; 2). In intra- and extra articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula; 3). In distal tibia/fibula long bones which include the metaphyseal and diaphyseal regions of the tibia and fibula in the ankle. The Ankle Fracture System is not for Spinal Use.

The BioPro Foot Plating Systems consists of Predicate Foot and Ankle Bone Plate and Locking Screw implant components found with many companies with orthopedic markets in the United States. These Foot Bone Plate Systems fracture fixation & osteotomy implant devices consist of the following categories: - 1. Forefoot System - 2. Mid & Hindfoot System - 3. Ankle Fracture System A brief and concise description of each system is as follows: 1. The BioPro Forefoot System is designed to address a variety of indications in forefoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include: 1). Straight Fracture Plates, 2). T-Shaped Fracture Plates, 3). Y-Shape Fracture Plates, 4). L-Shaped Fracture Plates, 5). Cloverleaf Fracture Plates, 6). TMT 1 Medial Fusion Plates, 7). Open Wedge Fusion Plates, 8). MTP Fusion Plates, 9). MTP Fusion Revision Plates, and 10). Dorsal TMT 1 Step Fusion Plates, - in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.0mm, 2.5mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing. A full set of Ancillary Instrumentation (Depth Gauge, Drill Guides, Drill Bits, Screwdrivers, Retractors, Bending Irons, K-wire with stop, Distraction/ Compression Device and MTP Fusion Reamers) is available with the system. The BioPro Forefoot System is offered both EO STERILE and Non-sterile for single-use. 2. The BioPro Mid & Hindfoot System is designed to address a variety of indications in midfoot & hindfoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include: 1). Straight Fracture/Fusion Plates, 2). T-Shaped Fracture/Fusion Plates, 3). L-Shaped Fracture/Fusion Plates, 4). Cloverleaf Fracture/Fusion Plates, 5). X-Shaped Fracture/Fusion Plates, 6). Retangular Fracture/Fusion Plates, 7). Cotton Osteotomy Plates, 8). Dwyer Step Plates, 9). Evans Osteotomy Plates, 10.) Plantar TMT Plates, 11). Distal Medial & 3 - 4 Column Plates and 11). ORIF & Standard Calcaneal Plates - in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to A.STM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing. A full set of Ancillary Instrumentation (Depth Gauge, Drill Guides, Drill Bits, Screwdrivers, Retractors, Reduction Forcepts, Bending Pliers, Osteotomes, K-Wires with stop and Distraction/Compression Device) is available with the system. The BioPro Mid & Hindfoot System is offered both EO STERILE and Non-sterile for single-use. 3. The BioPro Ankle Fracture System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system is composed of many locking plate types which include: 1). Distal Fibula Plates, 2). Medial Distal Tibia Plates, 3). AnteroLateral Distal Tibia Plates, 4). Posterior Distal Tibia T-Plates, 5). Straight Low Contact Plates, and 6). Straight 1/3 Tubular Plates - in various plate shapes, lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.8mm, 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of either Medical Grade CP Titanium (to ASTM F67) or 6-4 Alloyed Titanium (to ASTM F136) materials with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing. A full set of Ancillary Instrumentation (Depth Gauge, Drill Guides, Drill Bits, Screwdrivers, Retractors, Reduction Forcepts, Bending Pliers, Osteotomes, K-Wires with stop, and Distraction/Compression Device) is available with the system. The BioPro Ankle Fracture System is offered both EO STERILE and Non-sterile for single-use.

The BioPro - Infinity™ Plate Anchor System is indicated for ligament reattachment or fixation. The BioPro Infinity™ Plate and Screw(s) is supplied 'sterile' and intended for 'singleuse' only. The system is not intended for spinal use.

The BioPro- Infinity™ Plate Anchor System is a multiple plate system composed of a: 1). 2-hole Curved Plate, 2). 1-hole 10mm Plate, 3). 1-hole 12mm Plate, 4). 1-hole 14mm Plate, 5). 3-hole Flat Straight Plate, and 6). 3-hole T-Plate. Two(2) 3.0mm Cancellous Screws in a 15mm and 20mm length accompany the system for fixing the plate through soft-tissue to bone. Both the plates and screws are manufactured from 6-4 Alloyed Titanium to ASTM F136 with an anodize Type II surface treatment. Ancillary screwdriver and K-wire instrumentation is offered as 'sterile' and disposable and is made available for implantation and removal of the device. The plate and screw implant combination with instrumentation is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.

The BioPro Kwick-Wire™ Universal Screw System is indicated for use in the internal fixation of fractures, fusions and revisions. The system is intended for but not limited to hand surgery, orthopedic surgery and podiatric surgery - but is not intended for Spinal Use.

The BioPro Kwick-Wire™ Universal Screw System comes in two diameter pin sizes of 2.5mm and 3.0mm and in a length of 4.0in. and is used for reduction and fixation of fractures appropriate for the size of the device. A mating compression nut of either the 2.5mm or 3.0mm size is mated with the proper pin size. Both the pin and nut are manufactured from either high strength 6-4 Alloyed Titanium to ASTM F136 or high strength 316 LVM Stainless Steel to ASTM F138. Ancillary instrumentation is available for device implantation and removal. The implant is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.

- A press fit implant for arthritic degradation of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of the normal ambulatory function of the forefoot. - Degenerative arthritis - Rheumetoid arthritis - Bunion deformity associated with arthritis of the metatarsal-phalangeal joint - A titanium version is available for use only in patients susceptible to nickel-chromium allergies. The BioPro Hemi-Edge Toe System is not intended for spinal use.

The BioPro Hemi-Edge Toe System will be available in two material options: it can be manufactured from either Cobalt Chrome (ASTM F1537) or Titanium 6-4 (ASTM F1472). The system will be available in 5 sizes in both porous and non-porous coated versions as a press fit design. The basic implant design is unchanged to the original design which consists of a contoured articulating surface to simulate the normal concave articulation of the proximal phalanx in the toe. The current implant is a modification to the original implant design which includes a partial surrounding lip or rim adjacent the outer perimeter of the articulating surface. The purpose of the lip/rim is to prevent osteophyte bone on-growth to the articular surface that could inhibit function of the device. Two(2) small windows in opposite comers of the lip/rim allow either visual or needle verification in seating of the prosthesis on resected bone. The current implant design still includes the diamond shaped stem which provides a press-fit intra-medullary fixation. Ancillary instrumentation is available for device implantation and removal. The implant is sold in a 'sterile' condition for single-use. The sterilization method used is Ethylene Oxide.

The BioPro Bipolar Head is intended for use in combination with a BioPro PSL femoral stem for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: • Femoral neck and trochanteric fractures of the proximal femur • Osteonecrosis of the femoral head • Revision procedures where other devices or treatments for this indications have failed

The BioPro Bipolar Head consist of a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner in a cobalt chrome outer shell and UHMWPE retention ring with a Ti-6Al-4v spring. These bipolar heads include outer diameters ranging from 38-60mm, in 1mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38-42 mm) have an inner diameter that mates with a 22mm diameter femoral head; the larger bipolar heads (43-60mm) have an inner diameter that mates with a 28mm diameter femoral head. The BioPro Bipolar Head may be used in conjunction with a BioPro PSL femoral stem (K872535 and K871462) for hemiarthroplasty.

| HBS-Mini (2.5mm) | HBS Standard (3.0mm) | |-------------------------------------|---------------------------------| | Scaphoid fractures | Scaphoid fractures | | Lunate fractures | Carpal fractures and non-unions | | Capitate | Capitellum fractures | | Trapezial fractures | Metacarpal fractures | | Metacarpal and metatarsal fractures | Phalangeal fractures | | Phalangeal fractures | Distal radial fractures | | Radial head fractures | Radial head fractures | | Ulnar styloid fractures | Ulnar styloid fractures | | Osteo-chondral | Small joint fusions | | Small joint fusions | Humeral head fractures | | | Glenoid fractures | | | Intercarpal fusions | | | Interphalangeal fractures | | | Metatarsal osteotomies | | | Tarsal fusions | | | Malleolar fractures | | | Patellar fractures | | | Osteo-chondral fractures |

The BioPro HBS screw is designed for hand, foot and small bone fragment repairs or fusions. Uses include osteotomy fixation, joint arthrodesis or post traumatic fragment repair. The BioPro HBS screw is made of titanium in compliance with ASTM F136-02a. The screw is similar to other screws available on the market. The HBS screw is cannulated and comes in two diameters, 2.5mm and 3.0mm. Each screw is available in several lengths ranging from 6mm up to 40mm in length. The screws have a Torx driving head. The new versions of the screw will be provided sterile.

The BioPro Femoral Heads are indicated for use for significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis; revision of failed femoral head replacement, cup arthroplasty, or other hip procedures; proximal femoral fractures, avascular necrosis of the femoral head; non-union of proximal femoral neck fractures; other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. The BioPro hip system (PSL) is for cemented and non-cemented use.

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Indications For Use: The BioPro K-Wire is indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

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The BioPro Bipolar Head is intended for use in combination with a BioPro femoral stem for uncemented primary or revision arthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: - Femoral neck and trochanteric fractures of the proximal femur; . - Osteonecrosis of the femoral head; - Revision procedures where other devices or treatments for these indications . have failed.

The BioPro Bipolar Head consists of a factory assembled UHMWPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm) have with a iiim ater that mates with a 28 mm diameter femoral head. The BioPro Bipolar an infor diamotor that may be a BioPro femoral stem (K882146) for arthroplasty.