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The TITANEX® Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.

The TITANEX® Screw Systems contain cannulated bone screws and general instrumentation as a reconstruction solution for foot and ankle applications. The screws are provided in various diameters and lengths with headed, headless, partially, and fully threaded configurations. The implants are composed of titanium alloy. The instrumentation are composed of stainless steels. The devices are provided non-sterile and are intended to be steam sterilized prior to use.

The TACTIX Vector Syndesmosis System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following syndesmotic trauma using a TACTIX Vector Suture Loop and Buttons. The TACTIX Vector System features the following advantageous characteristics: a tensioner to apply suture tension for surgical repair, line lock suture technology without the need to tie a knot, removal of periosteum through a minimal medial skin nick, a larger medial button, and a small thru hole in the bone, only large enough to pass a 2.0 mm suture loop. The TACTIX Vector Syndesmosis System can be used in conjunction with Vilex fibular bone plates and screws, as deemed necessary by the surgeon.

The TACTIX Vector Syndesmosis System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the TACTIC Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma using a TACTIX Vector suture loop and buttons. The TACTIX Vector System features the following advantageous characteristics: a tensioner to apply suture tension for surgical repair, line lock suture technology without the need to tie a knot, removal of periosteum through a minimal medial button, and a small thru hole in the bone, only large enough to pass a 2.0 mm suture loop. The TACTIX Vector Syndesmosis System can be used in conjunction with Vilex fibular bone plates and screws, as deemed necessary by the surgeon. The TACTIX Vector Syndesmosis System is composed of two titanium alloy buttons and one UHMWPE suture. The instruments of TACTIX System are composed of stainless steel, UHMWPE, and nylon material. The TACTIX Vector Syndesmosis System is intended for single use and provided sterile to the end user via ethylene oxide sterilization.

The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalcaneal arthrodesis (fusion) Specific indications include: - · Post-traumatic or degenerative arthritis - · Previously infected arthrosis - Revision ankle arthrodesis - Failed total ankle arthroplasty - · Avascular necrosis of the talus - · Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease - Rheumatoid arthritis - · Osteoarthritis - Pseudarthrosis - · Trauma (malunited tibial pilon fracture) - · Charcot foot - · Severe endstage degenerative arthritis - Severe defects after tumor resection - Pantalar arthrodesis - · Post-traumatic arthrosis - · Neuroarthropathy

The Vilex Redemption Duo system consists of implantable intramedullary nails, endcaps, and locking screws manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and PEEK per ASTM F2026) that are implanted into the talocrural region to facilitate tibiotalocalcaneal arthrodesis (fusion). A variety of implant sizes are provided to accommodate individual patient anatomy. The Vilex Redemption Duo system includes device specific instrumentation for use in site preparation, implantation, and removal of the implants and instruments are packaged clean and non-sterile in a sterilization tray with instructions for sterilization prior to surgery.

The TITANEX™ MICROBEAM and TITANEX™ ARTEMIS Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.

The TITANEX™MICROBEAMS and the TITANEX™ ARTEMIS screw systems contain fully threaded screws as a reconstruction solution providing various diameters of cannulated screws. The TITANEX™ MICROBEAM's are provided in diameters of Ø2.0mm, Ø2.5mm, and the TITANEX™ ARTEMIS screws are Ø3.0mm, and Ø4.0mm. The Screws are a fully threaded design and come in variable lengths from 16mm - 70mm. The Ø2.0mm family: 16mm -50mm, for the Ø2.5mm family: 16mm - 50 mm, for the Ø3.0mm family: 12mm - 50mm, for the Ø4.0mm family: 16mm - 70mm. All screws are provided in 2mm increments. All implants' components are manufactured from titanium (Ti-6AI-4V, ASTM F136). Specific instrumentation including wires, drills, depth gages, and torx drivers are required for use with the system. The TITANEX™ Screws instruments are manufactured from stainless steel and aluminum.

The ALPHALOK™ Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include: - · Forefoot, Midfoot, and Hindfoot Osteotomies - · Metatarsals and Metacarpals Corrections and Osteotomies - · Stabilization and Fixation of Metatarsal and Metacarpal Fractures - Stabilization and Fixation of Ankle Fractures - Syndesmosis Joint Stabilization - · Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints - · Flatfoot and Cavus Foot Corrections - Charcot Fixation The ALPHALOKTM Ankle Fx Plates are intended for fixation of fractures, and non-unions of the distal tibia and fibula such as: - · Lateral Malleolar Fractures - · Syndesmosis Injuries - · Medial Malleolar Fractures - Bi-Malleolar Fractures - Tri-Malleolar Fractures - · Posterior Malleolar Fractures - · Distal Anterior Tibia Fractures - · Vertical Shear Fractures of the Medial Malleolus - Pilon Fractures - · Distal Tibia Shaft Fractures - Distal Fibula Shaft Fractures - Distal Tibia Periarticular Fractures - · Medial Malleolar Avulsion Fractures - Lateral Malleolar Avulsion Fractures

The ALPHALOK™ Plating System is a multi-indication solution providing polyaxial locking technology and low-profile plate designs. The ALPHALOK™ Ankle Fx plates and screws are intended to treat various fracture patterns of the ankle specifically tibia and fibula. The intent of this submission is to expand indications to include ankle fractures, whereas the previous submissions for the ALPHALOK™ Plating Systems (K221558, K212348) were for forefoot and midfoot respectfully. All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136). Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.

The ALPHALOK™ Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include: - · Forefoot, Midfoot, and Hindfoot Osteotomies - · Metatarsals and Metacarpals Corrections and Osteotomies - · Stabilization and Fixation of Metatarsal and Metacarpal Fractures - · Stabilization and Fixation of Ankle Fractures - · Syndesmosis Joint Stabilization - · Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints - · Flatfoot and Cavus Foot Corrections - · Charcot Fixation

The ALPHALOK™ Plating System, consisting of the ALPHALOK™ Met Fx and ALPHALOK™ Recon, is a multi-indication reconstruction solution providing polyaxial locking technology and lowprofile design. The ALPHALOK™ Met Fx contains various sizes of non-sterile straight plates, T plates, Y plates, Jones plates, mini plates, and locking and non-locking screws. The ALPHALOK™ Recon contains various sizes of non-sterile fusion plates, Lapidus plates, peanut plates, straight plates, tab plates, T-plates, MTP plates, Cotton & Evans plates, utility plates, and Ankle Fracture plates along with locking and non-locking screws, and washers. All implant components are manufactured from titanium (Ti-6A1-4V, ASTM F136). Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.

ALPHALOK™ Plating System bone plates and screws are indicated for use in bone fractures and osteotomies of small bones or small bone fragments of the hand and wrist.

The ALPHALOK™ Plating System, consisting of the ALPHALOK™ Met Fx Mini Plates, is a multi-indication reconstruction solution providing polyaxial locking technology and low profile design. All implant components are manufactured from titanium (Ti-6Al-4V, ASTM F136). Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.

The Correx Software is intended to be used as a component of multilateral external fixation system for the Vilex External Fixation System with the indications listed below: - Stabilization of Fractures & Osteotomy - Rear and Mid-foot Arthrodesis - Adult and Pediatric Leg Lengthening - Correction of Bone Deformity in Upper & Lower Extremities

The Correx Software, intended for use with the Dynex Ring Fixation System (K202054), is an optional-use computational environment that can be used for determining the orientation of bone segments and external fixator elements attached to a bone to treat fractures and bone deformities. The software includes user interface, processing, data storage, and display functions. The Correx Software can be used to visualize the position of a moving bone segment and to compute the strut lengths necessary to implement any desired translation or rotation. The Software program does not control the device. The Software program does not control any hardware (such as rings, struts, wires) directly. The goal of the Software program is to provide the Surgeon with a tool for determining the length of the six struts connecting the two circular rings. The Surgeon must decide where a bone segment should line up and the angulation and translation necessary for the treatment. The magnitude and direction of any rotation or translation is ultimately the responsibility of the Surgeon.