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The Newdeal Interphalangeal Implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes. Examples include: - rigid or semi-rigid hammertoe deformity . - revision of failed arthroplasty or arthrodesis . - 2nd toe shortening .

The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of: - . Fixed or semi-fixed hammer toe - Revision of failed arthrodesis or arthroplasty ● - . Shortening due to length excess of the second toe This interphalangeal implant configuration will be offered in two different sizes.

The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction. Examples include: - Arthrodesis in hand or foot surgery . - . Fracture management in the foot or hand - . Mono or Bi-cortical osteotomies 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 Newdeal Uni-CP™ U-Plate is intended for arthrodesis of the second and third cuneo-metatarsal and the inter-cuneiform second and third joints. The size and number of the plate(s) used should be adapted to the specific indication.

The Newdeal Compression Plates will offer the combination of two concepts: - By widening the "eye" (diamond shaped opening) on the interaxis of the plate. . mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse. - . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer.

The HALLU® PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metastarso-phalangeal joint, including cases of. - Hallux rigidus . - Severe hallux valgus (IM angle >20° and HV angle >40° ) . - . Deformity from rheumatoid arthritis - Failed previous surgical procedure . - Traumatic arthritis . - Neuromuscular instability . Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.

The Newdeal HALLU® PLATES is a low profile Titanium plate dedicated to first metatarsophalangeal arthrodesis. The system includes both HALLU" -FIX C plates as well as HALLU -FIX S plates. The plates are used in conjunction with Newdeal SNAP-OFF® screws.

The PANTA® Nail system is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: - Post-traumatic and degenerative arthritis involving both ankle and subtalar joints - Rheumatoid arthritis - Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body - Revision of failed total ankle arthroplasty with subtalar intrusion - Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis) - Avascular necrosis of the talus - Neuroarthropathy or neuropathic ankle deformity - Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease - Severe pilon fractures with trauma to the subtalar joint.

The modified Panta® Nail (dia. 10mm and XL) is ideally suited for tibiotalocalcaneal fusion indications. These Nails affords rigid, load sharing fixation that incorporates a simple nailmounted, in-line method of compression across the arthrodesis site. The Panta® Nail (dia. 10mm and XL) affords even more torsional rigidity and better calcaneal purchase through its two transcalcaneal locking screws that are inserted from posterior to anterior, using a nail-mounted targeting device. Calcaneal screws eliminate significant rotation, preventing the calcaneus from "rocking" on the nail during weight-bearing. Some screws allow a sufficient stability for the fixation between calcaneus, talus and tibia. The Panta® Nail (dia. 10mm and XL) is provided with sterile end caps which sit flush to the end of the nail and protect the internal threads from tissue ingrowth.

The HALLU® Lock Plates are intended for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Including cases of: - Hallux rigidus - Severe hallux valgus (IM angle >20° and HV angle >40°) - Deformity from rheumatoid arthritis - Failed previous surgical procedure - Traumatic arthritis - Neuromuscular instability. The HALLU® Lock plates must be fixed with the SURFIX® fixed angle locking system and with the SURFTX®-Alpha variable angle locking system of 2.7mm or 3.0mm diameter (screws and lock-screws). Addition of a Newdeal® QWIX® screw crossing the joint is strongly recommended for optimal arthrodesis consolidation

The Newdeal HALLU® Lock Plate System is a low profile Titanium plate dedicated to first metatarso-phalangeal arthrodesis. The HALLU Lock C plates are pre-bent with 10° valgus and 10° dorsiflexion. The HALLU Lock S plates are available with 10° valgus and 10° or 5° dorsiflexion. Pre-operative bending is possible to completely fit to the anatomical shape of the joint. Their fixation is provided by SURFIX and SURFIX ALPHA locking screws.

The Newdeal Compression Plate is intended for fixation of bone fractures or for bone reconstruction. Examples include: - Arthrodesis in hand or foot surgery - Fracture management in the foot or hand - Mono or Bi-cortical osteotomies 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 size and number of the plate(s) used should be adapted to the specific indication.

The Newdeal Compression Plate will offer the combination of two concepts: - By widening the "eye" (diamond shaped opening) on the interaxis of the plate, mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse. This is the same principle as the Newdeal Compression Plate (K070447), UNI-CLIP (K011716) and Newdeal Large UNI-CLIP (K061594). - The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer. This is the same principle as the Locking System of the following predicate devices: Surfix Knee Osteotomy System (K041601), Newdeal Lisfranc Plates (K060474), Newdeal Lapidus Plates (K060476), Newdeal TTC Plates (K060473 and Newdeal Compression Plate (K070447).

The Newdeal TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction, including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal TIBIAXYS Plates are fixed with the SURFIX ALPHA Locking System 3.5mm diameter screws and Lock screws. Anterior Plates for ankle Arthrodesis have to be fixed with the TIBIAXYS cortical 4mm diameter screws.

The Newdeal TIBIAXYS System consists of bone plates and screws for arthrodesis, osteotomies and fractures of ankle joint, distal tibia and fibula. All plates and screws are manufactured from titanium alloy and are provided either sterile or non-sterile.

The QWIX Positioning Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - Mono or Bi-cortical osteotomies in the foot or hand (including Hallux Valgus treatment) - Fractures management in the foot or hand - - Fixation of bone fragments in long bones or small bones fractures - - Arthrodesis in hand, foot or ankle surgery - The size of the chosen screw should be adapted to the specific indication.

The QWIX® Positioning Screw is a cannulated fully threaded screw. It also has a self-tapping screw tip. It is provided in diameters 5.5 mm and 7.5 mm and in length from 30 mm to 80 mm for the 5.5 mm and from 40 mm to 120 mm for the 7.5 m. The QWIX® Positioning Screw is made from Titanium alloy (Ti-6Al-4V ELI).

The Newdeal Compression Plate is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - Arthrodesis in hand or foot surgery - Fractures management in the foot or hand - Mono or Bi-cortical osteotomies 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 size and number of plate(s) used should be adapted to the specific indication.

The Newdeal Compression Plate will offer the combination of two concepts: - By widening the "eye" (diamond shaped opening) on the interaxis of the plate, mechanical deformation leads to narrowing of the interaxis of the two legs and thus provides compression between the two bone fragments to fuse. This is the same principle as the UNI-CLIP (K011716) and Newdeal Large UNI-CLIP (K061594). - . The rigidity of the "legs" is obtained using the Newdeal Locking System including a screw and a washer. This is the same principle as the Locking system of the - . following predicate device: Surfix Knee Osteotomy system (K041601), Newdeal Lisfranc Plates (K060474), Newdeal Lapidus Plates (K060476) and Newdeal TTC Plates (K060473). The plate will be available with 2 or 4 holes and with interaxis of 20, 25 or 30 mm. Fixation of the Newdeal Compression Plate is provided by two or four Screws & washers, which are the same as for the Lapidus Plate (K060474) and Lisfranc Plate (K060476). Plates, screws and washers will be provided either sterile or non-sterile. The Locking System (Screw + washer) will be made from Titanium alloy Ti-6Al-4V or 316L Stainless Steel.

The Basal Dorsal Plate is intended for fixation of osteotomy of the basis of the first metatarsal. Examples include: Moderate to severe Hallux Valgus, Hallux varus

The Basal Dorsal Plate is designed for fixation of basal osteotomy of the 1st metatarsal. Characteristics of the plate have taken into account all the requirements associated with basal osteotomy: Anatomical shape adapted to the dorsal curve of the basis of the 1st metatarsal, in two different lengths for better adaptation to the specific anatomy of the patient. Fixation with CALCANEA 3.5mm screws in variable angle design for easier positioning and grip into the bone, and a locking design for better stability of the system. The Basal Dorsal Plate and CALCANEA screws are made from titanium alloy (Ti-6AI-4V ELI), which are color-coded for ease of identification. Fixation of the Basal Dorsal Plate is provided by four CALCANEA screws, already cleared with the CALCANEA Plate and Screws system (510(k) K041786). The plates and screws are provided sterile with the Basal Dorsal Plate.