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The PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow, or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric and small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.

The PediFlex™ Flexible Nail System includes stainless steel and titanium flexible nails, interlocking clamps, clamp screws and end caps for the application of aiding bone fracture repair and healing. All the implants are MR conditional. The system is implanted using Class II and Class I exempt surgical instruments. The PediFlex™ flexible nails are provided in 316L stainless steel and titanium alloy (Ti-6Al-4V). The 316L stainless steel flexible nails are available in diameters ranging from 1.5 mm to 4.0 mm in increments of 0.5 mm. The titanium alloy (Ti-6Al-4V) flexible nails are available in diameters ranging from 1.5 mm to 4.5 mm in increments of 0.5 mm. The PediFlex™ interlocking clamps are designed to hold flexible nails in place after insertion by clamping the nail and being fixed to the bone. The use of the interlocking clamps is optional. The interlocking clamps are manufactured from both 316L stainless steel and titanium alloy (Ti-6Al-4V) materials. The 316L stainless steel interlocking clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm and 4.0 mm which are to be used with 316L stainless steel flexible nails in diameters of 3.0 mm, 3.5 mm and 4.0 mm. The 316L stainless steel clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The titanium alloy (Ti-6Al-4V) interlocking clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm which are to be used with titanium alloy (Ti-6Al-4V) flexible nails in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm. The titanium alloy (Ti-6Al- 4V) clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The material of the clamp must match the material of the nail and screw in the surgery. The PediFlex™ end caps are designed to affix to the exposed nail tip to help prevent soft tissue irritation. The use of the end cap is optional. They are not a structural element and impart no additional strength to the construct. The subject end caps are manufactured in titanium alloy (Ti-6Al-4V) and are available in diameters ranging from 1.5mm to 4.5mm with 0.5mm increments which are to be used with titanium alloy (Ti-6Al-4V) flexible nails in diameters ranging from 1.5mm to 4.5mm with 0.5mm increments. The material of the end cap must match the material of the nail used in the surgery. The flexible nails, interlocking clamps, clamp screws and end caps in PediFlex™ Flexible Nail System are offered both sterile and non-sterile. All other Class II implants and instruments of the PediFlex™ Flexible Nail System are offered non-sterile to be sterilized by the end-user.

The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

Kirschner Wires are used for; · As guide pins for insertion of other implants · Bone reconstructions · Fixation of bone fractures and osteotomies · Implanted through the skin for traction applied to the skeletal system

Biomet Inc manufactures a variety of internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Biomet Kirschner Wires (K-wires) are rigid yet malleable wires with penetrating tips such that they may be inserted through tissue and into bone to alow for traction of bone fragments as desired or for alignment quides for other bone fixation implants. These wires are available in multiple diameters, same length and unthreaded (smooth) versions. Biomet Kirschner Wires are single use and provided in both sterile configurations. Unless supplied sterile, metallic internal fixation devices must be sterilized prior to surgical use.

The OSSIO® Pin Product Family is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace) in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. OSSIOfiber® Compression Screws are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, ostectomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace) in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The OSSIOfiber® devices are made of degradable poly (L-lactide-co-D, L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alphahydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The Hammerdesis™ Interphalangeal Fusion System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

The Hammerdesis™ Interphalangeal Fusion system is composed of a counter rotation ring implant, recovery dowel and K-wire to be used in conjunction with a peg and hole fusion of the phalanges. The implant comes in two different sizes to accommodate differing anatomies. The counter rotation ring has axial spikes that prevent either side of the joint from rotating and allow fusion of the joint.

OSSIOfiber® Cannulated Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The OSSIOfiber® Cannulated Trimmable Fixation Nails are fixation devices made of degradable poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the fibers are made from materials that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. The OSSIOfiber® Cannulated Trimmable Fixation Nails are cannulated, supplied sterile, for single patient use only, and non-pyrogenic. The additional device included in this submission is 100 mm long and 3.5mm core diameter (4.0 mm outer diameter). The OSSIOfiber® Cannulated Trimmable Fixation Nails are designed to be used with commonly available orthopedic surqical tools such as ISO 9714 compatible instrumentations.

Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include: - Osteotomies or arthrodesis of fractures management in the foot or hand - Fixation of small bone fragments, in long bones or small bones fractures

The Electro-Spec Steri-Caps are indicated for use in protection of protruding ends of wires. Examples of procedures that may leave protruding wires include: - Osteotomies or arthrodesis of fractures management in the foot or hand - Fixation of small bone fragments, in long bones or small bones fractures- Fixation of small bone fragments, in long bones or small bones fractures Steri-Caps are comprised of a pin ball intended to be placed on the end of a wire or pin protruding from bone, secured with a setscrew, and used to protect the user and wire. The pin balls are offered in diameters of 8.95mm and 12.13mm, and designed to accommodate K-wires or pins less than 1.65mm in diameter. The set screws are offered in lengths of 3.30mm. The longer of the set screws is referred to as the Long Set Screw. Each set screw is threaded with an M4 x 0.7 outer thread, and has a 2.50mm diameter hexagonal cannulation for use with the 2.5mm driver. The 2.5mm driver is used to set the set screw once the pin or wire has been placed through the pin ball. Each pin ball and set screw is offerent materials, namely 6A4V ELI Titanium per ASTM F136, 304 SST, or 17-4 SST, Heat Treat to condition H900. The component is then treated with an ES (Electro-Spec) Surface Treatment, intended to add hardness, scratch resistance, hydrophobicity, and wear resistance. The ES Surface Treatment is a 4-to-15-micron thick, electroplated alloy that can be plated on numerous types of surfaces providing better scratch-resistance, corrosion, and tarnish properties than conventional surfaces can provide due to its hardness and hydrophobic properties. A satin finish is provided on all components. All components and the instrument are offered non-sterilization before use

The Tyber Medical Pin and Wire System is indicated for use in fixation of small bone fragment(s) of hand or foot), bone reconstructions, and as guide pins for inplants or implantation through the skin so that traction may be applied to the skeletal system.

The Tyber Medical Pin and Wire System is designed for hand, foot, and small bone fragment repairs or fusions. Uses include fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants. It is manufactured from stainless steel, and Titanium Alloy. They are available in a variety of lengths, and tips to accommodate different anatomic sizes of patients. The devices are provided non-sterile, single use. Non-sterile devices are intended to be sterilized at the point of use. The pins and wires are made from stainless steel (316L per ASTM F-138) and titanium alloy (Ti-Al-4V ELI per ASTM F136).

The HTS is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the HTS can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.

The SECURE-LOCK is indicated for fixation of bone or soft tissue to bone, and is intended as a fixation device, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair such as Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.

The SECURE-LOCK fixation device consists of a sterile and non-absorbable polyester and ultrahigh molecular weight polyethylene blended braid that forms a loop on a titanium alloy button. The button sits on the cortex over the exit to a bone tunnel, suspending the loop inside the tunnel to provide secure, strong fixation for ligament repair and reconstruction. The SECURE-LOCK fixation device is supplied with polyester sutures that are used to assemble and deliver the device.