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The Nextremity Solutions Nextra® CH Cannulated Hammertoe System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

The Nextra® CH Cannulated Hammertoe System consists of a two-part cannulated bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implant diameters range from 2.75mm to 4.2mm. The middle screw implant diameters range from 2.75mm to 5.0mm in increments of 0.75mm. The proximal and distal screw implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system offers an optional fixation method using a Kirschner wire (K-wire) in conjunction with the screw implants for additional fixation and temporary stabilization. The K-Wire is intended to be removed at the discretion of the physician upon joint fusion. The k-wires provided are manufactured from 316 Stainless Steel conforming to ASTM F138. The system includes the necessary surgical site preparation and insertion instruments, including implant specific drivers. The implants and instruments of the system are provided sterile for single use.

The Nextremity Solutions CalcShift™ Displacement Calcaneal Osteotomy System is indicated for osteotomies, nonunions, malunions, revisions, fusions, and reconstruction of the calcaneus requiring a medial or lateral displacement osteotomy.

The CalcShift Displacement Calcaneal Osteotomy System is a foot and ankle plate and screw system consisting of a plate and screw implants. The plate is 1.6mm thick, 19.75mm long, and 11.5mm wide. The plate has 4 screw holes. The system provides locking and non-locking screws that are 3.5mm in diameter and range in length from 10mm to 70mm. The system includes cannulated compression screws and cannulated stability screws that are 5.0mm in diameter and range from 30mm to 100mm in length. The plate and screws are provided sterile. The plates and screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.

The StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including: - · Arthrodesis in hand or foot surgery - · Mono or bi-cortical osteotomies in the foot or hand - · Fracture management in the foot or hand - · Distal or proximal metatarsal or metacarpal osteotomies - · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.

The StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), 3.5mm(small) and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and 20mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The system provides accessory instruments designed for preparation of the implant site and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile and non-sterile for single use. The instruments are provided non-sterile, reusable or non-sterile, single use and must be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets.

The Nextremity Solutions InCore® Subtalar System is intended for reduction and internal fixation of arthrodeses, osteotomies, and nonunions of the bones and joints of the foot. The three-part construct is specifically intended for internal fixation for Subtalar Joint Arthodesis (also known as Subtalar Joint Fusion).

The InCore® Subtalar System consists of a post and two headless compression screws. Posts are available with an 8.0 mm diameter, in an 28mm length, and in right and left orientations. Screws are available in a 5.5 mm diameter and lengths of 50 to 120mm. The post is inserted into the talus and compression screws are inserted into the calcaneus and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136. The system is provided with a set of accessory instruments, including an implant specific targeting guide, designed for preparation of the implant site and insertion of the implants into bone.

The Nextremity Solutions Nextra CH Cannulated Hammertoe System is intended for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

The Nextra® CH Cannulated Hammertoe System (originally cleared as DuoHex™ CH Cannulated Hammertoe System- K200840) consists of a two-part cannulated bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implant diameters range from 2.75mm to 4.2mm. The middle screw implant diameters range from 2.75mm to 5.0mm in increments of 0.75mm. The proximal and distal screw implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system offers an optional fixation method using a Kirschner wire (K-wire) in conjunction with the screw implants for additional fixation and temporary stabilization. The K-Wire is intended to be removed at the discretion of the physician upon joint fusion. The k-wires provided are manufactured from 316 Stainless Steel conforming to ASTM F138. The system includes the necessary surgical site preparation and insertion instruments, including implant specific drivers. The implants and instruments of the system are provided sterile for single use.

The Stratum Ankle Fusion Plating System is indicated for use in stabilization of fractures or osteotomies, intra and extra articular fractures, and multi-fragmentary fractures, non-union and malunion, joint fusion and reconstruction of small bones of the feet and ankles including the distal tibia, talus, and calcaneus.

The Stratum Ankle Fusion Plating System is a foot and ankle plating system consisting of plates and screw implants. The plates are 3.5mm thick, range in length from 73.66mm to 107.70mm, and range in width from 22.10mm to 40.64mm. The plates have between 10 and 13 locking screw holes and 1 to 2 slots. The plates are provided sterile. The system provides locking and nonlocking screws that are available in diameters of 3.5mm and range in length from 10mm to 80mm. The screws are provided sterile and non-sterile. The system includes cannulated crossing screws that are 6.5mm in diameter and range from 26mm to 90mm in length. The cannulated screws are provided sterile. The plates and screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.

The Nextremity Solutions Nextra PEEK Hammertoe Correction System is indicated for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

The Nextra PEEK Hammertoe Correction System consists of a two-part mating bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implants are available in diameters of 3.2mm and 4.2mm. The middle screw implant is available in diameters of 3.5mm, 4.25mm, and 5.0mm, with 0° and 10° angled options. The proximal and distal screw implants are manufactured from polyetheretherketone (PEEK) conforming to ASTM F2026. The system includes implant specific drivers and taps, and other necessary surgical site preparation instruments. The implants and instruments of the system are provided sterile for single use.

The Nextremity Solutions Stratur " Reduced Size Foot Plating System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the foot and ankle, particularly in ostopenic bone.

The Stratum™ Reduced Size (RS) Foot Plating System is a foot and ankle plating system consisting of plate and screw implants. The plates range in length from 25.5mm and in width from 6.35mm to 18mm and feature between 2 and 10 screw holes. There is one diameter, 2.4mm, for all screw types including locking, non-locking, and MDS screws. The screws range in length from 8mm to 50mm and are provided sterile. The system also includes a sterile set of accessory instruments along with individually packaged drill guides / drill bits, screw driver shafts, threaded wire with nut, and olive wires designed for preparation of the implant site and insertion of devices into the bone. The plates, screws, instrument kits, drill guide / drill bits, screw driver shafts, threaded wire with nut, and olive wires are all packaged individually in separate sterile packaging. The plates, non-locking and locking screws are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The multi-directional locking screws are manufactured from Co-Cr-Mo conforming to ASTM F1537.

The Nextremity Solutions DuoHex™ CH Cannulated Hammertoe System is intended for small bone reconstruction limited to inter-phalangeal repair and fusion of the lesser toes.

The DuoHex™ CH Cannulated Hammertoe System consists of a two-part cannulated bone screw implant construct. The screw implants are provided in various sizes. The proximal screw implant diameters range from 2.75mm to 4.2mm. The middle screw implant diameters range from 2.75mm to 5.0mm in increments of 0.75mm. The proximal and distal screw implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136. The system offers an optional fixation method using a Kirschner wire (K-wire) in conjunction with the screw implants for additional fixation and temporary stabilization. The K-Wire is intended to be removed at the discretion of the physician upon joint fusion. The k-wires provided are manufactured from 316 Stainless Steel conforming to ASTM F138. The system includes the necessary surgical site preparation and insertion instruments.

The Nextremity Solutions InCore® MPJ System is a three-part construct intended for internal fixation for First Metatarsophalangeal Joint Arthrodesis (also known as 1st MPJ Fusion).

The InCore MPJ System consists of a post and two headless compression screws. Posts are available with a 4.9mm diameter, in an 18mm length, and left orientations. Screws are available in a 2.7mm diameter and lengths of 16 to 52mm. The post is inserted into the metatarsal head and compression screws are inserted into the phalange and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.