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The indications for the I.T.S. Intramedullary Nailing System (INS) - Proximal Femur include intramedullary treatment of fractures and stabilization after tumor resection in the area of the proximal femur, as well as combinations that additionally affect the shaft area using the long nails. The indications for use of the I.T.S. INS Proximal Femur include: All Nails: - · Stable and unstable pertrochanteric fractures - · Intertrochanteric fractures - · Combinations of fractures listed above Additionally for Long Nails: - Subtrochanteric fractures - · Proximal fractures as listed above associated with shaft fractures - · Pathological fractures in regions as listed above - · Nonunions and malunions in regions as listed above

The I.T.S. INS Proximal Femur Nail consists of the following implants: 1) Nails: The Proximal Femur Nails are designed for the treatment of femoral fractures. The Femur Nails are available in distal diameters ranging from 9 to 14mm and lengths of 180mm (short nail), 240mm (intermediate nail), and 260 to 480mm in 20mm increments (long nail). 180mm and 240mm nails have a single, oblong hole distally, while all nails with a length over 260 have a round hole, an oblong hole and another round hole for distal fixation. The oblong hole allows for both static and dynamic locking configurations. All Trochanteric Nails are locked proximally with a Lag Screw. The set screw engages with the lag screw and allows translation while preventing rotation. Endcaps close the top of the nail and are available in 0mm, 5mm, 10mm, 15mm and 20mm lengths. 2) Lag Screw Lag screws are cannulated with a major diameter of 10.5mm and lengths ranging from 70mm to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136. 3) Set Screw There are two types of set screws available. Inferior short and standard with a diameter of 6.6mm. The Length of the inferior short version is 45mm and the standard lengths are 70 to 130mm in 5mm increments. They are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136. 4) Distal Cortical Locking Screw Distal locking screws are fully threaded, with a diameter of 5.0mm and lengths ranging from 25mm to 120mm in 5mm increments (2.5mm increments available from 25-70mm). Thev are available in titanium alloy (Ti-6Al-4V ELI) per ASTM F136. 5) Instrumentation I.T.S. INS Proximal Femoral Nail Instrumentation consists of implant-specific targeting devices which help facilitate insertion of the nails, lag screws, and distal locking screws. Targeting devices are manufactured from stainless steel and carbon fibre reinforced PEEK. Other instrumentation includes drills, drill guides, k-wires and screwdrivers. All nails and screws are provided Sterile for single-use.

The I.T.S. Pelvic Reconstruction Systems (PRS RX & PRS Phoenix) are indicated to stabilize one or more pelvic bone fractures in the pelvis in an adult patient. Indications for use of the I.T.S. Pelvic Reconstruction System (PRS RX) include: - Fractures of the acetabulum - Fractures of the pelvic ring - Fractures of the quadrilateral surface - Fractures of the symphysis - Fractures of the ilium - Fractures of the SIJ - Ilio-iliac distance osteosynthesis - Symphysis pubis disruptions, osteotomies, arthrodesis and sacroiliac joint dislocations - Revision surgery of pseudoarthroses, non-unions and mal-unions The I.T.S. PRS RX System is not intended for spinal use. Indications for use of the I.T.S. Pelvic Reconstruction System (PRS Phoenix) include: - Fractures involving the Posterior Wall & Posterior Column - Fractures involving the Anterior Column of the Acetabulum - Fractures involving the Quadrilateral Surface - Symphyseal Disruptions & Para-symphyseal Fractures - Fractures of the ilium - Fractures of the SIJ - Dorsal neutralization plating for posterior pelvic ring fractures - Osteotomies, arthrodesis and sacroiliac joint dislocations - Revision surgery of pseudoarthroses, non-unions and mal-unions The I.T.S. PRS Phoenix System is not intended for spinal use. Indications for use of the I.T.S. Infra-acetabular screw placement include: - Fractures involving the anterior column, e.g. anterior column plus posterior hemitransverse (ACPH) and associated both column (ABC) fractures The I.T.S. Infra-acetabular screw is not intended for spinal use. Indications for use of the I.T.S. 8.5mm Cannulated Screws & Washer include: - Pelvic fractures The I.T.S. 8.5mm Cannulated Screws & Washer are not intended for spinal use.

The I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) encompasses a number of fracture fixation subsystems of multiple plate designs for fracture fixation and reconstruction of pelvic ring fractures in the pelvis. The I.T.S. Pelvic Reconstruction Plating System (PRS RX & PRS Phoenix) consists of the following plate types: 1) A Curved Plate at a 2.5mm thickness with 4 to 16 hole length sizes, 2) A Straight Plate at a 2.5mm thickness with 10 to 14 hole length sizes, 3) A SIJ Closed Plate at a 2.5mm thickness in a 4-hole size, 4) A SIJ L-Plate at a 2.5mm thickness in a 5-hole size, 5) A J-Plate at a 2.5mm thickness with 6 to 16 hole length sizes, 6) A Symphysis Plate at a 4.0mm thickness in a 4 & 6 hole size, 7) A Symphysis Plate Curved at a 4.0mm thickness in a 6 & 8 hole size, 8) A RIM Plate at a 2.5mm thickness in a 10 & 14 hole, Right & Left size. 9) A Posterior Wall Plate at a 2.5mm thickness in a 6 hole, Right & Left size. 10) A Posterior Wall Plate II at a 2.5mm thickness in a 7 & 8 hole, Right & Left size, 11) A Quadrilateral Column Plate at a 2.5mm thickness in a Small & Large, Right & Left size, 12) A Quadrilateral Supporting Plate at a 2.5mm thickness in a Right & Left size. 13) A Posterior Wall Plate Extended at a 2.5mm thickness in a Small & Large, Right & Left size, 14) A Posterior Column Plate at a 2.5mm thickness in a 8-hole, Right & Left size, All plate designs are low profile in thickness and made from Implant Grade 2 CP Titanium material (to ASTM F67). The PRS RX & PRS Phoenix Plating System encompasses a 3.5mm Cortical Locking and Standard Screw and a 4.2mm Cancellous Locking Screw in various lengths. All bone screws are pre-drilling and self-tapping in design and manufactured from Implant Grade 5 high strength 6-4 Alloyed Titanium (to ASTM F136). A threaded Spike allows inter-operative plate fixation to bone fragments. The Spike is also manufactured from Implant Grade 5 high strength 6-4 Alloyed Titanium material (to ASTM F136). All components (plates, screws, spike) have a anodize 'DOTIZE' Type II surface treatment preparation. Ancillary instrumentation (Drills, Drill Guides, Insertion Guides, Clamps, Bending Heaver, Measuring Gauges, and Screwdrivers) is made available for bone fragment reduction and plate/screw placement and insertion. All plates, screws, spike are provided Non-Sterile for single-use.

The intended use of the I.T.S. Hand Locking Plates System - HLS is to draw two or more aligned bone fragments together to facilitate healing in an adult patient. The I.T.S. Hand Locking Plates System - HLS is indicated for use in fracture fixation of: - the phalanges, - the metacarpal bones, - the carpal bones, - for arthrodesis, - for corrective osteotomies, and - for subcapital radial head fractures. The I.T.S. Hand Locking Plates System is not for spinal use.

The I.T.S. Hand Locking Plates System -- HLS consists of Predicate small bone trauma implant components commonly found with large companies with orthopedic markets in the United States. The I.T.S. HLS System consists of 1.0 and 1.5mm thick plates in Straight, T-Shape, Y-Shape, L-Shape (Left & Right), Extended and Square Plate configurations (with multiple hole sizing) that utilize both Locking and Non-Locking self-tapping Screws in 1.5mm, 1.8mm and 2.3mm sizes in various lengths. A 2.0mm Headless Compression Screw in various lengths is also available. All small plate components are manufactured from Commercialy Pure (CP) Titanium material to ASTM F67 and allow for minor intra-operative forming/contouring by the surgeon to fit the small bone anatomy. All screws consist of a 6-4 Alloyed Titanium material to ASTM F136. All I.T.S. small plates and screws are processed with an anodize DOTIZE surface treatment. The low-profile and contoured small plate design minimizes soft-tissue irritation for the patient. Associated instrumentation such as Plate Holder, Drills, Drill Guides, Depth Guage, Countersink Reamers, Guide Wire and ancillary instrumentation is available. All small plates and screws are provided Non-Sterile.

The intended use of the I.T.S. IM Nail Systems is to stablilize and fix long bone fractures to facilitate healing in an adult patient and is composed of the following categories: The I.T.S. CFN - Cannulated Femur Nail System is indicated for use in long bone femur fracture fixation which include: Open and closed femur shaft fractures; Intertrochanteric, supracondylar and ipsilateral fractures; High subtrochanteric fractures; Combined inter and subrochanteric fractures; Pertrochanteric fractures; Pseudoarthrosis and correction osteotomy; Non-union, malunion and delayed union fractures; Pathological fractures, impending pathologic fractures, and tumor resections and; Fractures proximal to a total knee arthroplasty; The system is not for spinal use. The I.T.S. CTN - Cannulated Tibia Nail System is indicated for use in long bone tibia fracture fixation which include: Proximal, metaphyseal, epiphyseal and distal shaft fractures; Segmental, simple, compound and comminuted fractures; Transverse, oblique and spiral fractures; Surgically created defects using osteotomies,such as for leg length discrepencies or deformity; Pathologic fractures; Pseudoarthrosis, non-union, mal-union and delayed union of the tibia; Fractures involving osteopenic and osteoporotic bone; Open fractures of the tibia and; Reconstruction of the tibia after tumor resection and/or bone loss. The system is not for spinal use. The I.T.S. CHN - Cannulated Humeral Nail System is indicated for use in long bone humerus fracture fixation which include: Dislocated, unstable 2, 3 and 4 part fractures of the proximal humerus; Valgusimpacted 4 part fractures of the proximal humerus; Proximal humeral fractures with diaphyseal extension into the shaft; Pseudoarthrosis, non-unions, mal-unions and malalignments of the proximal humerus and; Pathological and impending pathological fractures. The system is not for spinal use.

The I.T.S. IM Nail Systems CFN-CTN-CHN consists of Predicate type intramedullary nail trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'Intramedullary (IM) Nail trauma implant devices' consist of the following categories: 1. CFN - Cannulated Femur Nail System 2. CTN - Cannulated Tibia Nail System 3. CHN - Cannulated Humeral Nail System A brief and concise description of each system is enclosed as follows: 1. CFN - Cannulated Femur Nail System: The I.T.S. CFN -Cannulated Femur Nail System is a curved/bowed Intramedullary(IM) Nail in a right and left configuration to fit the natural bow of the femur and is inserted proximally/antegrade over 3.5/3.0mm calibrated guide wires. The CFN - IM Nail is composed of various nail diameters in sizes of 9.0, 10.0, 11.0, 12.0 and 13.0mm and various lengths from 240mm to 480mm in 20mm increments. The CFN - IM Nail accepts a 6.5mm Cortical Screw in various lengths for cross-screw fixation in the larger diameter proximal region of the nail and a 4.7mm Triple-lead Cortical Screw in various lengths for crossscrew fixation in the distal portion of the nail. A dynamization slot is located in the distal portion of the nail and an End Cap (in +0, +5, +10, +15, +20, +25 & +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole/slot location. All CFN - JM Nail, End Cap and Screw components are manufactured from Alloyed 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment. Associated instrumentation such as Insertion Guide accessories, guide pins, drill sleeves, drill guides, drills, screwdriver, depth gauge with removal instruments are available with the system. All CFN - IM Nails, End Caps and Screws are provided Non-Sterile. 2. CTN - Cannulated Tibia Nail System: The I.T.S. CTN -Cannulated Tibia Nail System is a universal straight Intramedullary(IM) Naïl with a 50 proximal and distal bend configuration to fit the anatomy of the tibia and is inserted proximally/antegrade over 3.5/3.0mm calibrated guide wires. The CTN - IM Nail is composed of various nail diameters in sizes of 9.0, 10.0. 11.0. and 12.0mm and various lengths from 240mm to 420mm in 1 5mm increments. The CTN - IM Nail accepts only the 4.7mm Triple-lead Cortical Screw in various lengths for cross-screw fixation in both the proximal/distal portion of the nail. A dynamization slot is located in the proximal portion of the nail and an End Cap (in +0, +5, +10, +15, +20, +25, +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole/slot and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole location. All CTN - IM Nail, End Cap and Screw components are manufactured from Alloved 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment. Associated instrumentation such as Insertion Guide accessories, guide pins, drill sleeves, drill guides, drills, screwdriver, depth gauge and removal instruments are available with the system. All CTN - IM Nails, End Caps and Screws are provided Non-Sterile. 3. CHN - Cannulated Humeral Nail System: The I.T.S. CHN -Cannulated Humeral Nail System is a right and left Intramedullary (IM) straight Nail with a 4 proximal bend configuration to fit the anatomy of the humerus and is inserted proximally over 2.0/2.5mm calibrated guide wires. The CHN - IM Nail is composed of various nail diameters in sizes of 7.0. 8.0. and 9.0mm and various lengths from 140mm to 320mm in 10 and 20mm increments. The CHN - IM Nail accepts only a 3.5mm Double-lead Cortical Screw in various lengths for cross-screw fixation in both the proximal/distal portion of the nail. An End Cap (in +0, +5, +10, +15, +20, +25 & +30 lengths) is available for proximal closing of the nail. The nail proximal cross-screw insertion uses Insertion Guide instrumentation for location of the hole and screw insertion preparation throught the bone cortex and nail. The nail distal cross-screw insertion uses x-ray fluoroscopic imaging for nail distal hole location. All CHN - IM Nail, End Cap and Screw components are manufactured from Alloyed 6-4 Titanium material to ASTM F136 and are processed with an anodize DOTIZE surface treatment. Associated instrumentation such as Insertion Guide accessories, guide pin, drill sleeves, drill guides, drills, screwdriver, depth gauge and removal instruments are available with the system. All CHN -IM Nails, End Caps and Screws are provided Non-Sterile.

The intended use of the I.T.S. Extemity Fixation Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following catagories: The I.T.S. FLS - Foot Locking Plates System is indicated for use in internal fixation, reconstruction or arthrodesis of small bones including the fore, mid and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and treatment of fractures. Not for spinal use. The I.T.S. HCS - Headless Compression Screw System for sizes of 3.5mm or smaller is indicated for use in fixation small bone fractures or for small bone reconstruction including; mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalageal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fractures (articular fragments), ulnar styloid fractures, radial head fractures, capitellum fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions. And for sizes 4.3mm or larger is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degeneralive transformations of long bones in the hindfoot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen compression screw should be adapted to the specific indication. Not for spinal use The I.T.S. HOL – Hallyx Osteotomy Locking Plate System is indicated for use as an intramedullary self-locking plate for distal metatarsal osteotomies and for Hallux Valgus osteotomies up to a corrective angle of 25°. Not for spinal use. The I.T.S. Twist-Off Screw System is indicated for use for small bone fixation of bone fractures or for bone reconstruction. Examples include small bone fragments, Weil-Osteotomy, Mono-Cortical fixation, Osteotomies and fractures fixation in the foot and hand. Not for spinal use.

The I.T.S. Extremity Fixation Systems consists of Predicate extremity trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'extremity trauma implant devices' consist of the following categories: 1. FLS - Foot Locking Plates System 2. HCS - Headless Compression Screw System 3. HOL- Hallux Osteotomy Locking Plate 4. Twist-Off Screws A brief and concise description of each system is enclosed as follows: 1. FLS - Foot Locking Plates System: The I.T.S. FLS - Foot Locking Plates System is composed of various plate types(13) designed to address a wide variety of indications for fractures in the foot. The overall system is composed of a smaller bone series of locking plates (12 types) utilizing 2.4mm, 2.7mm and 3.0mm locking/non-locking screws and a larger bone calcaneus plate utilizing 3.5mm and 4.2mm locking/non-locking screws. The smaller bone system of twelve(12) plate designs consist of the following: (1) MTP Plate, (2) Curved Plate, (3) Straight Plate, (4) H-Shape Plate, (5) Square Plate, (6) I -- Shape Plate, (7) L-Shape Extended Plate, (8) L-Shape Extended, 1mm Step Plate, (9) L-Shape Extended 45º Plate, (10) T-Shape Plate, (11) T-Shape Extended Plate, and (12) TMT Plate. The larger bone system consists of a (13) Calcaneus Plate. All plate systems are manufactured from Commercially Pure (CP) Titanium material to ASTM F67 and allow for minor intra-operative forming/ contouring by the surgeon to fit the bone anatomy. All screws consist of 6-4 Alloyed Titanium material to ASTM F136. Small holes in the plate allow intermediate 'k-wire' bone fracture segment positioning for reducing and aligning the fracture bone segments while positioning the plate and introduction of multiple sizes of locking/non-locking screws as needed for stabilizing the fracture - when using x-ray fluroscopy. All I.T.S. Plates and Screws are processed with an anodize DOTIZE surface treatment. The low-profile and contoured plate design minimizes soft-tissue irritation for the patient. Associated instrumentation such as disposable drills, mills & wires/guide wires, and ancillary instrumentation is available. All plates and screws are provided Non-Sterile. HCS - Headless Compression Screw System: The I.T.S. 2. HCS - Headless Compression Screw System consists of six(6) sizes of compression screws (in sizes 2.0, 2.5, 3.0, 3.5, 4.3 and large/long bone 7.5mm) for small bone extremity and reconstruction fixation/arthrodesis procedures. All screws consist of a 6-4 Alloyed Titanium material to ASTM F136. All I.T.S. Compression Screws are processed with an anodize DOTIZE surface-treatment. Associated instrumentation such as disposable wires/guide wires, cannulated spiral drills, countersink drills, and ancillary instrumentation is available. All screws are provided Non-Sterile. 3. HOL - Hallux Osteotomy Locking Plate: The I.T.S. HOL -Hallux Osteotomy Locking Plate consists of a Nail Plate in three(3) sizes with Screws in various lengths for Halux and distal metatarsal foot/toe bone deformities. The Nail Plate is manufactured from CP Titanium to ASTM F67 and the Screws from 6-4 Alloyed Titanium to ASTM F136. All I.T.S. Nail Plate and Screws are processed with an anodize DOTIZE surface treatment. Associated instrumentation such as guide wire, disposable drill, template, insertion/removal and ancillary instrumentation is available. All Plates and Screws are provided Non-Sterile. 4. Twist-Off Screws: The I.T.S. Twist-Off Screws consist of a 2.0mm and 2.7mm twist-off shank screws in various lengths. All Turn-Off Screws are manufactured from 6-4 Alloyed Titanium to ASTM F136 and are utilized in metatarsal/phalangeal small bone fixation/osteotomy procedures. All I.T.S. Twist-Off Screws are processed with an anodize DOTIZE surface treatment. All Screws are provided Non-Sterile.

The Indications for Use of the I.T.S. GmbH - Distal Ulna Locking (DUL) and Ulna Osteotomy Locking (UOL) Plate Systems is to stabilize fractures/osteotomy in the long bone of the distal and mid-ulna of an adult patient. The I.T.S. GmbH - Ulna Locking Plate (DUL & UOL) Systems are not intended for spinal use.

The I.T.S. Ulna Locking Plates are composed of the DUL (Distal Ulna Locking) & UOL (Ulna Osteotomy Locking) Systems which are fracture fixation plating systems for repairing bone factures located in the distal and mid-ulna bone in the human body. The DUL System consist of three(3) Standard plate lengths of 3, 4, & 6 hole and one(1) Small pre-contoured plate shape in a left/right configuration to fit the distal ulna. The UOL System consists of a single, 5 hole, straight plate for mid-ulna bone osteotomy procedures. Both plate systems are manufactured from Commercialy Pure (CP) Titanium material to allow for minor intra-operative forming/contouring by the surgeon. The plate design concept offers various type locking screw fixed-angle constructs using angular stability locking screws into the plate. Both locking and non-locking high strength 6-4 Alloyed Titanium screws in sizes of 2.4mm cortex locking, 2.7mm cortical non-locking, and 3.0mm cancellous/ cortical locking screws are offered. All screws are self-tapping for insertion into bone. Small holes in the plate allow intermediate 'k-wire' bone fracture segment positioning for reducing and aligning the fracture bone segments while positioning the plate and introduction of multiple sizes of locking/non-locking screws as needed for stabilizing the fracture -- when using x-ray fluroscopy. All I.T.S. Ulna Locking Plates and Screws are processed with an anodize 'DOTIZE' surface treatment. The low-profile and contoured plate design minimizes soft-tissue irritation for the patient. A full compliment of instrumentation is available for use with the system.