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The Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward and medial displacement of the talus, thus blocking excessive pronation and the resulting sequela.

The Solana Surgical Gaitway Implant is a one-piece device made of Titanium Alloy intended to be implanted in the Sinus Tarsi of the foot. The implant is available in a range of sizes (5) ranging from 6.5 mm to 11.5 mm. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the production of this implant.

The Solana Surgical LLC, Sola Fix Twist Screw Implant System is intended to provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot.

The Solana Surgical Implant is a one-piece device made of Titanium Alloy intended to be used as a screw for bone fixation, fusion, osteotomy or reconstruction of the hand and foot. The implant is available in a range of sizes (6) including 2.0mm diameter and length range of 11-16mm. The screw driving portion of the screw is intended to separate from the screw head once the screw seats to the bone.

The Solana Surgical LLC, Metatarsal Decompression Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is intended for single use to be used with bone cement or press fit without bone cement.

The Solana Surgical Implant is a one-piece device made of Cobalt Chromium (with titanium plasma spray coated stem) or Titanium, intended to replace the articulating surface of the metatarsal bone at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes to match the geometry of the metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends proximally in the intramedullary canal of the distal metatarsal. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.

The Solana Surgical LLC, Hemi Phalangeal Implant System is intended for use as a hemi-arthroplasty implant for the metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is intended for single use to be used with bone cement or press fit without bone cement.

The Solana Surgical Implant is a one-piece device made of Cobalt Chromium (with titanium plasma spray coated stem) intended to replace the articulating surface of the phalangeal bone at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes (3) to match the geometry of the metatarsal phalangeal joint. Design features include an articulating surface and a stem which extends distally in the intramedullary canal of the proximal phalanx. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.

The Solana Surgical LLC, Metatarsal Decompression Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint. The device is intended for single use to be used with bone cement.

The Solana Surgical Implant is a one-piece device made of Cobalt Chromium, intended to replace the articulating surface of the first metatarsal at the metatarsalphalangeal (MTP) joint. The implant is available in a range of sizes to match the geometry of the metatarsal head. Design features include an articulating surface and a stem which extends proximally in the intramedullary canal of the metatarsal. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the development of this implant.