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The intended use of the Ortho Solutions UltOS Plating System fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing. The Ortho Solutions UltOS Plating System is Indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the feet, ankles, and toes skeleton. This implant should only be used with the Ortho Solutions UltOS Plating System. Combination with other implants or instrumentation is not permissible. The Ortho Solutions UltOS Plating System is not intended for spinal use.

The Ortho Solutions UltOS Plating System is designed to address a variety of indications in rearfoot, midfoot, and forefoot reconstuctive fixation surgery. The overall system is composed of Twelve(12) Plate Types that accept both a smaller 2.7mm and larger 3.5mm Locking/ Non-locking Screw ( in various lengths of 8mm thru 50mm) with all screw heads of uniform size to fit any plate type. The UltOS System 'Twelve(12) Plate Types' consist of the following: 1). A Arthrodesis Wedge Plate (AWP) in 5 sizes of 0, 2, 4, 6 & 8mm. plate wedge widths, 2). A General Fusion Straight Plate (GFS) in 2 sizes of a 2 & 4 screw hole plate. 3). A General Fusion "T" Plate (GFT) in 3 sizes of a 2, 4 & 6 screw hole plate. 4). A Metatarsophalangeal Plate (MTP) in 3 sizes, Left & Right, of a Small, Medium & Large plate size, 5). A Opening Wedge Locking Plate (OWL) in 6 sizes of 0, 3, 4, 5, 6 & 7mm plate wedge widths, 6). A Opening Wedge Plate (OWP) in 6 sizes of a 0, 2.5, 3, 4, 5 & 7mm plate wedge widths. 7). A Calcaneal Step Plate (CSP) in 3 sizes of 8, 10 & 12mm plate step heights. 8). A General Fusion "X" Plate (GFX) in 4 sizes of a Extra Small, Small. Medium & Large plate size, 9). A Lapidus Plate (LAP) in 4 sizes, Left & Right, of a 0, 2, 4 & 6mm plate offset heights, 10). A Rearfoot Reconstruction Plate (RRP) in 3 sizes of a 6, 8 & 14 screw hole plate. 11). A Tarsal Fusion Plate (TFP) in 3 sizes of a 12, 14 & 16mm plate length, and 12). A Universal Locking Plate (ULP) in 5 sizes of a 12, 16, 20, 24 & 30mm plate length. Screw diameters of 2.7mm and 3.5mm with either Locking or Non-Locking features and Cannulated 3.5mm self tapping screws in various lengths are also included in the UltOS Plating System. Associated instrumentation such as compression and distraction pliers, disposable drills & wires/guide wires, drill guides, T8 torx screwdrivers and ancillary instrumentation is available. All plates and screws are manufactured from Alloyed Titanium Ti-6Al-4V to ASTM F136. All plates, screws, drills and K-wires are offered both 'Sterile' and 'Non-Sterile' to the customer.

The Ortho Solutions Limited Oxford Ankle Fusion Nail (AFN) System is a tibiotalocalcaneal (TTC) solid fusion system that has been developed for the following indications: - Failed ankle replacement - Arthritis of ankle and subtalar joint - Correcting neuromuscular imbalance of hindfoot, where bone fusion is required - Revision of failed ankle and/or subtalar fusion - Revision of failed Tibiotalocalcaneal (TTC) fusion - Talar Avascular Necrosis (AVN) - Charcot - Trauma - Neuroarthropathy - Pseudoarthrosis - Rheumatoid arthritis

The Ortho Solutions Oxford Ankle Fusion Nail (AFN) System is composed of three(3) diameter (10, 11 & 12mm) sizes by two(2) lengths (150 & 180mm) as a straight nail, cannulated, to accept a 3.9mm Guide Pin. The cannulated nail is inserted through a dorsal heel incision over a guide wire using x-ray fluoroscopy within the ankle boney anatomy and distal tibia medullary canal. The guidewire is used to achieve adequate positioning. A Revision Nail in all sizes is also offered where the angled transverse hole is removed. A low-profile head 5.0mm Cortical Transverse Bone Screw (in 26 lengths of 20 - 115mm in 2 & 5mm increments) is used for proximal and distal multiple 'cross-screw' fixation after compression of the ankle joint space. Dynamization Slots(2) are located at the Proximal End of the nail. Also offered is a Standard and Locking End Cap for closing the distal end of the nail. The Locking End Cap rests and locks against the most distal Transverse 5.0mm Cortical Screw. For completion of long bone fractures, End Caps in 3 lengths (+0, +5 & +10) and in 3 diameters (10, 11 & 12mm) are used for distal IM Nail Length Extension as necessary. As well, all End Caps seal the end of the nail to avoid ingrowth of tissues. All bone hole preparation and bone screw insertion is with the assistance of intra-operative x-ray fluoroscopy. All implant components are offered 'Sterile' for Single Use. With the Intramedullary Nail inserted into the ankle bone, an instrument 'Targeting Arm' with alignment holes is attached to the distal end of the nail. This external Targeting Arm allows proper orientation, preparation, and alignment of the proper cannula for transverse and angled drilling of bone screw holes into the nail and ankle anatomy cortical and cancellous bone. The bone hole preparation is for proper alignment to the referenced transverse and angled holes within the Intramedullary Nail for insertion of Transverse 5.0mm Cortical Bone Screws. All implant components are made from 6-4 Alloyed Titanium material to ASTM F 136 and are anodized with a Type II surface preparation. The IM Nail, End Cap and Transverse Screws may be removed when long bone fracture(s) are healed or the ankle joint space is fused. A full complement of instrumentation (external Targeting Arm Main Jig. guide wire/pins, drill guides/sleeves, cannulated tissue protector sleeves, depth gauge, reamers, reaming rod, drills, drivers, cannulated guide tube & trocar, etc.) is available with the system. A 'sterile single use' disposable pack is available encompassing a guide pin, guide rod, drills, reamer, reaming rod and exchange tube. A implant extraction/removal instrumentation set is also made available.

The intended use of the Ortho Solutions Trauma Plates for Osteosynthesis of fixation device(s) is to draw two or more aligned bone fragments together to facilitate healing. Ortho Solutions Bone Plates, Bone Screws, and Washers System is indicated for use in fixation of various fractured bones. Mini plates and screws 3.5mm or smaller are intended for use in small bones in the hand or foot and include the metacarpal, metatarsal, and phalange bones. Small and large plates and screws 4.0mm and larger are intended for use in large and long bones which can include the clavicle, scapula, pelvis, calcaneus, talus and long bones (humerus, ulna, radius, femur, tibia, and fibula) in the skeletal anatomy. Ortho Solutions Compression Hip Screw CHS/SCS System is indicated for fracture fixation in the proximal and distal regions of the human anatomy skeletal femur. Specific indications include: intracapsular fractures of the femoral neck; trochaneric and subtrochanteric neck fractures; osteotomies for patients with diseases or deformities of the hip; hip arthrodesis; supracondylar fractures and distal femoral fractures. The Ortho Solutions Trauma Plates for Osteosynthesis is not intended for spinal use.

The Ortho Solutions Trauma Plates for Osteosynthesis consists of general predicate type trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'general trauma implant devices' consist of the following categories: 1. Bone Plates, Bone Screws and Washers System 2. Adult Compression Hip Screw (CHS/SCS) System 1. Bone Plates, Bone Screws and Washers System: This implant system consists of a Mini Fragment System (MFS), a Small Fragment System (SFS), and a Large Fragment System (LFS). The Mini Fragment System is composed of 2.7mm A.C.P Plates in various hole lengths. These mini plates are secured to bone using 1.5mm, 2.0mm, and 2.7mm Cortical Screws. All Mini Fragment System plates and screws are intended for use in small bone extremity skeletal anatomy. The Small Fragment System is composed of 1/3 Tubular, 3.5mm A.C.P., 3.5mm Reconstruction, 3.5mm Cloverleaf, and 3.5mm 'T' - Plates in various hole lengths, Left, Right, and Oblique configurations. These small fragment plates are secured to bone using 3.5mm and 4.0mm cortical and cancellous screws, selftapping, partial, and fully threaded. A 7 x 3.6mm Washer is also offered. All Bone Screws with or without the washer can be used separate from the plates. All Small Fragment plates and screws are intended for use in small bone skeletal anatomy. The Large Fragment System is composed of 4.5mm Narrow A.C.P, 4.5mm Broad A.C.P., 'T', 'T-Buttress', and 'L-Buttress' Left & Right Angled Plates in various hole length configurations. These large plates are secured to bone using 4.5mm, 4.0mm Malleolar, and 6.5mm cortical and cancellous screws, self-tapping, partial, and fully threaded. A washer is also offered. All bone screws with or without the washer can be used separate from the plates. All large fragment plates and screws are intended for use in large and long bone skeletal anatomy. All bone plates, bone screws, and washers are made of surgical grade 316LVM Stainless Steel to ASTM F138. All plates, screws, and washers are offered 'sterile' to the customer. 2. Adult Compression Hip Screw (CHS/SCS) System: This implant system consists of various angled (950 for SCS, 130°, 135°, and 150° for CHS) high strength forged plates in multiple hole lengths, various Lag Screw lengths with various length Compression Screws, and various length 4.5mm Cortical Screws for securing the plate to femoral bone. Associated guide pin, drills, and ancillary instrumentation is available. The system is intended for use in repair of fractures of the femoral hip neck/head and supra-condylar area of the skeletal femur. All components are manufactured of surgical grade 316LVM Stainless Steel to ASTM F138. All plates and screws are offered 'sterile' to the customer.

The intended use of the Ortho Solutions Extremity Fixation Implants for Osteosymthesis System of bundled fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing. The Ortho Solutions Extremity Fixation Implants for Osteosynthesis System is used in adult patients. The Ortho Solutions Foot Plating System (FPS) is indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet, ankles, and toes skeleton. The Ortho Solutions Memo Staple System is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis. The Memo Staple is also indicated for use in fixation of soft tissue to bone such as anterior cruciate reconstruction. The Ortho Solutions Foot Osteotomy System (FOS) is indicated for alignment and stabilization of small bone fractures including: fixation of small bones, such as those in the foot and ankle for treatment of fractures, non-unions, or mal-unions; ligament reconstructions; osteochondritis dissecans; arthrodesis of the foot and ankle; small bone osteotomies, including first metatarsal head osteotomy and metatarsal osteotomies. The Ortho Solutions Staples System is indicated for fixation of bone fractures or bone reconstruction. The staples are also indicated for use in fixation of soft tissue to bone. The Ortho Solutions Compression Screws System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The Ortho Solutions TwistFix™ Snap-Off Screws System is indicated for fixation of bone fractures or for bone reconstruction. Examples include: 1) Fixation of small bone fragments, 2) Weil Osteotomy, 3) Mono-cortical fixation, and 4) Osteotomies and fractures fixation in the foot and hand. The Ortho Solutions Extremity Fixation System (EFS) of a low profile head screw is indicated for use in fixation of small bone fractures, nonunions, arthrodesis, and osteotomies of the small bones in the hand or foot. The Ortho Solutions Extemity Fixation Implants for Osteosynthesis System is not intended for spinal use.

The Ortho Solutions Extremity Fixation Implants for Osteosynthesis consists of Predicate Trauma Implant components commonly found with large companies with orthopedic markets in the United States. These 'small bone extremity trauma implant devices' consist of the following categories: 1. Foot Plating System (FPS) 2. Memo Staple System 3. Foot Osteotomy System (FOS) 4. Staples System 5. Compression Screws System 6. TwistFix™ Snap-Off Screws System 7. Extremity Fixation System (EFS) A brief and concise description of each system is enclosed as follows: 1. Foot Plating System (FPS): The Ortho Solutions Foot Plating System (FPS) is designed to address a variety of indications in rearfoot, midfoot, and forefoot reconstuctive fixation surgery. The overall system is composed of a smaller 2.7mm and larger 3.5mm locking/nonlocking plating category of system(s). The 2.7mm system of three(3) plate designs consisting of a Universal Locking Plate 2.7 (ULP-2.7), a MetaTarso Phalangeal Plate (MPT), and a Open Wedge Locking Plate (OWL) - all utilized with either a locking or non-locking 2.7mm Screw in various lengths. The 3.5mm system of seven(7) plate designs consisting of a Universal Locking Plate 3.5 (ULP-3.5), a Lapidus Plate(LAP), a Arthrodesis Wedge Plate (AWP), a Rearfoot Reconstuction Plate (RRP), a Tarsal Fusion Plate (TFP), a Calcaneal Step Plate (CSP), and a Calcaneal Locking Plate (CLP) - all utilized with either a locking or non-locking 3.5mm Screw in various lengths. A 3.5mm Cannulated Screw System in various lengths with Washer is also included in the FPS System. Associated instrumentation such as trial plates, disposable drills & wires/guide wires, and ancillary instrumentation is available. All plates, screws, and washer are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136. All plates, screws and washer are offered 'sterile' to the customer. 2. Memo Staple System: The Ortho Solutions Memo Staple System consists of four(4) staple sizes (at 10mm, 12mm, 20mm, and 25mm) manufactured from a Nickel-Titanium Nitinol material according to ASTM 2063 for foot reconstruction fixation/arthrodesis procedures. Only the room temperature superelastic properties of the nitinol material with the use of 'spreader/expander instrumention' is utilized in the surgical procedure to enact compression. Associated instrumentation such as templates, spreaders, expanders, guides, disposable drills and ancillary instrumentation is available. All Memo Staples are offered 'sterile' to the customer. 3. Foot Osteotomy System (FOS): The Ortho Solutions Foot Osteotomy System(FOS) consists of a Nail Plate/Staple with Screws in various lengths and Cannulated/Non-cannulated Compression Screws in various lengths for performing metatarsal/phalangeal osteotomies and/or small bone fixation reconstruction. All components are manufactured from CP Titanium to ASTM F67 and high strength 6-4 Alloyed Titanium to ASTM F136. Associated instrumentation such as guide wires, disposable drills and ancillary instrumentation is available. All staple plate/screw and compression screws are offered 'sterile' to the customer. 4. Staples System: The Ortho Solutions Staples System is composed of a Varisation Staple (smooth), a Compression Varisation Staple (tapered and ribbed), a Compression Staple (in 11mm, 12mm, 13mm, 15mm, and 20mm and width sizes), and a Blount Staple (in 22mm and width sizes) that are barbed/ribbed, angled, and smooth staple components manufactured from high strength 316LVM surgical grade stainless steel material according to ASTM F138. These staple systems are utilized for fixation of bone fractures or bone reconstruction and for fixation of soft tissues. A 'spreader instrument' is used to deform the compression staple diamond shape for bone compression fixation. Associated instrumentation such as spreaders and expanders with disposable drills and ancillary instrumentation is available. All Staples are offered 'sterile' to the customer. 5. Compression Screws System: The Ortho Solutions Compression Screws System consists of Cannulated Meta Compression and Cannulated Compression Screws in various lengths at a diameter of 3.0mm and is used for bone reconstruction in small bone extremities. All compression screws are manufactured from high strength alloyed Titanium to ASTM F136. Associated instumentation such as guide wires and disposable drills and ancillary instrumentation is available. All compression screws are offered 'sterile' to the customer. 6. TwistFix™ Snap-Off Screws System: The Ortho Solutions TwistFix™ Snap-Off Screws System comes in a 2.0mm and 2.5mm diameter with various lengths. All TwistFix™ Snap-Off Screws are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136 and CP Titanium to ASTM F67 and are utilized in metatarsal/ phalangeal small bone fixation/osteotomy procedures. Ancillary instrumentaion with disposable drills is available. All TwistFix™ Snap-Off screws are offered 'sterile' to the customer. 7. Extremity Fixation System (EFS): The Ortho Solutions Extremity Fixation System (EFS) consists of various Cannulated and Non-cannulated Flat Head low profile Fixation Screws in diameter sizes of 2.0mm, 2.4mm, 2.7mm, and 3.5mm, in various lengths and are manufactured from high strength 6-4 Alloyed Titanium material to ASTM F136. These flat head screws allow for a low-profile head-on the cortex bone surface for reduction of tissue irritation. Associated instrumentation such as guide wires, disposable drills and ancillary instrumentation is available. All Flat Head Screws are offered 'sterile' to the customer.

The intended use of the Ortho Solutions Trauma Implants for Osteosynthesis System is to draw two or more aligned bone fragments together to facilitate healing. Ortho Solutions K-Wires, Steinman Pins, Guide Pins, Fixation Pins, & Rush Pins are indicated for use in fixation of bone fractures, for bone reconstruction, for skeletal traction in alignment of long bone fractured segments, and as guide pins & wires for insertion of other implants. Ortho Solutions Cerclage Wire is indicated for use for bone fracture fixation. osteotomy, arthrodesis, correction of deformity, revision procedures where other treatments or devices have been unsuccessful, and bone reconstruction procedures. Ortho Solutions Cannulated Bone Screws and Washers are indicated for use over a guide pin or wire for aligned bone fracture fixation and bone fragment fixation. Washers of matching size to the cannulated bone screw may be used in certain applications. Cannulated bone screw sizes (with optional washer) of 4.0mm. 4.5mm. 5.0mm, 6.5mm, and 8.0mm are to be used with large and long bones in the skeletal anatomy. Specific indications, which are dependent in part on the diameter of the screw include: Minimally invasive fracture/joint reconstructions: Additive osteosynthesis for complex joint fractures; Multiple-fragment joint fractures; Femoral neck and femoral head fractures; Femoral supracondylar fractures; Tibial plateau fractures; Fractures of the head of the humerus & tibia; Cooper fractures of the tibia; Fractures of radius, wrist, ankle, elbow, and shoulder: Ligament fixation of the proximal humerus: Fractures of the acetabulum and dorsal pelvic ring: Condylar fractures; Ligament avulsion injuries; Malleolar and navicular fractures; Fractures of the calcaneus and talus; Arthrodesis of the ankle joint; and Avulsion fractures. The Ortho Solutions Trauma Implants for Osteosynthesis System is not intended for spinal use.

The Ortho Solutions Trauma Implants for Osteosynthesis consists of general predicate type trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'general trauma implant devices' consist of the following categories: 1. K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins, and Cerclage Wire 2. Cannulated Bone Screws & Washers A brief and concise description of each system is as follows: 1. K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins and Cerclage Wire: These implant devices are offered in various diameters and lengths. These devices are also offered in various point configurations on one or both ends and can be partially threaded, fully threaded, smooth, or calibrated. K-Wires, Steinman Pins and Rush Pins_position and draw fractured bone together to facilitate healing. Guide Pins are used to guide other implant devices into a fractured bone site area. External Fixation Pins are driven through the skin into bone and provide position and traction of fractured bone to allow bone healing. Cerclage Wire is soft to allow a 'wrap around' of fractured bones and draw fractured bone together to facilitate healing. All K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins and Cerclage Wires are made of surgical grade 316LVM Stainless Steel to ASTM F138 and/or 6-4 Alloyed Titanium to ASTM F136. All K-Wires, Steinman Pins, Guide Pins, Fixation Pins, Rush Pins and Cerclage Wires are offered 'Sterile' to the customer. 2. Cannulated Bone Screws & Washers: These implant devices consist of various length cannulated cortical and cancellous screws in a 4.0mm, 4.5mm, 5.0mm, 6.5mm, and 8.0mm thread diameter size in a full, partial, reverse-cutting, and self-tapping configurations. Washers of various sizes are matched to each screw type. Associated guide pin, drills, and ancillary instrumentation is available. The cannulated screws are intended for use over a guide pin or wire for bone fracture and bone fragment fixation. All cannulated screws and washers are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136. All cannulated screws and washers are offered 'sterile' to the customer.

Ortho Solutions sterile drill bits are intended to bore a hole into bone for insertion of a screw, wire, cable, plate, pin, bolt, etc.

All Ortho Solutions Sterile Single-Use Drills Bits are manufactured from common Stainless Steel materials that are either cold-worked or heat treated for hardness cutting durability and for corrosion resistance. Ortho Solutions sterile drill bits are available in various sizes and lengths, have a fluted design, and are either in a solid or cannulated form and may be calibrated. The Ortho Solutions drill bits have various end coupling mechanisms. Ortho Solutions drill bits will be provided to the user 'sterile'. Gamma Radiation will be used to sterilize the device.