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The Medline UNITE® Ancillary Foot Recon Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. Specific examples include: - Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) - Arthrodesis of the first metatarsophalangeal joint (MTP) including: - Primary MTP Fusion due to hallux ridgidus and/or hallux valgus - Revision MTP Fusion - Revision of failed first MTP Arthroplasty implant - Flatfoot Osteotomies: - Lateral Column Lengthening (Evans Osteotomy) - Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) - Medial Displacement Calcaneal Osteotomy (MDCO) - Midfoot / Hindfoot Fusions: - LisFranc Arthrodesis and/or Stabilization - 1st(Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions - Intercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - Talo-Navicular (TN) Fusion - Calcaneo-Cuboid (CC) Fusion - Medial Column Fusions (NC and 1st TMT) The Medline UNITE® Locking and Non-Locking Cortical Screws are indicated for use with the Medline Foot Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repar, and fracture fixation, appropriate for the size of the device. The Medline UNITE® Lisfranc Screws are intended to be used for fixation such as Lisfranc arthrodesis, first metatarsophalangeal arthrodesis, midfoot and hindfoot arthrodeses or osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

The Medline UNITE® Ancillary Foot Recon Plating System Plates and Screws are manufactured from Titanium Alloy (Ti-6Al-4V ELI). The System includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, 2.7mm, and 4.0mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates, 3.5mm crossplate screws to be used with the dual-mode compression slot(s) in select plates, and 3.7mm and 4.1mm solid Lisfranc screws. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits. The Medline UNITE® Ancillary Plating System Plates and Screws are within the currently marketed sizes and indications of the identified predicate devices.