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The TMC Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, phalanges, patella, ulnar styloid, capitellum, radial styloid. In the foot, the following specific examples are indicated with screws appropriate for the size of the device: - · mono or bicortical osteotomies - · distal or proximal metatarsal osteotomies - · weil osteotomy - · fusion of the metatarsalphalangeal joint - · fixation of osteotomies for Hallux Valqus treatment (such as Scarf, Chevron, etc.) - · Akin type osteotomy - · talonavicular fusions - · cuboid fusions Not for sninal use

Treace Medical Concepts (TMC) Screw Fixation System includes headed and headless cannulated screws. The TMC Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid, appropriate for the size of the device. All implantable components are manufactured from implant grade titanium alloy (Ti6Al4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation. The primary purpose of this Special 510(k) submission is to introduce additional screw options and accompanying instrumentation within the Treace Medical Concepts (TMC) Screw Fixation System. Secondly, Treace is providing the Agency notification regarding minor modifications implemented for the TMC Screw Fixation System via internal documentation.

The system is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.

TMC Compression Implant System is comprised of staple implants and related instrumentation for implantation. The implants are offered in multiple combinations of bridge lengths, leg lengths, cross sections, and cannulated versions to accommodate various anatomies. This includes two (2x1) or four (2x2, 4x1) legged implants. It also includes locking screws for additional fixation. All implantable components are manufactured from implant grade titanium alloy (Ti-6A1-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of the feet. The system can be used in both pediatric (aged >12-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples: * Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as: - Opening base wedge osteotomy - Closing base wedge osteotomy - Crescentic osteotomy - Proximal Chevron osteotomy - Distal Chevron osteotomy (Austin) - Transverse osteotomy * Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis * First metatarsal fracture fixation * Flatfoot Osteotomies - Lateral Column Lengthening (Evans Osteotomy) - Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) * Mid / Flatfoot Fusions - LisFranc Arthrodesis and/or Stabilization - Intercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - Talo-Navicular (TN) Fusion - Calcaneo-Cuboid (CC) Fusion * Medial Column Fusion

The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, anatomically curved plates, and intramedullary plates. The system includes 2.5mm, 2.7mm, and 3.0mm diameter cannulated and non-cannulated, locking, and non-locking screws ranging in lengths from 10-36mm. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of the foot. All implantable components are manufactured from implant grade titanium alloy (Ti6A14V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

The TMC Compression Implant System consists of implants and related instrumentation for implantation. The implants are offered in multiple combinations of bridge lengths, leg lengths, and cross sections to accommodate various anatomies. This includes two (2x2, 4x1) legged implants. The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle. The purpose of this Special 510(k) submission is to expand the implant and instrument options for the TMC Compression Implant System. The subject implants and instruments are modifications of the previously cleared TMC Compression Implant System (K222645). All implantable components are manufactured from implant grade titanium alloy (Ti-6AI-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of the feet. The system can be used in both adult and pediatric patients aged >12 years. In the foot, the system can be used for the following specific examples: · Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as: - Opening base wedge osteotomy - Closing base wedge osteotomy - Crescentic osteotomy - Proximal Chevron osteotomy - Distal Chevron osteotomy (Austin) - Transverse osteotomy • Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis - First metatarsal fracture fixation - · Flatfoot Osteotomies - Lateral Column Lengthening (Evans Osteotomy) - Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) - · Mid / Flatfoot Fusions - LisFranc Arthrodesis and/or Stabilization - Intercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - Talo-Navicular (TN) Fusion - Calcaneo-Cuboid (CC) Fusion - Medial Column Fusion

The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, anatomically curved plates, and intramedullary plates. The system includes 2.5mm, 2.7mm, and 3.0mm diameter cannulated and non-cannulated. locking, and non-locking screws ranging in lengths from 10-32mm. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of the foot. The purpose of this traditional 510(k) submission is to introduce additional plate and screw options within the Treace Medical Concepts (TMC) Plating System. All implantable components are manufactured from implant grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

The system is intended to be used for fracture fixation, and joint arthrodesis of the foot and ankle.

The Treace Medical Concepts (TMC) Compression Implant System consists of implants and related instrumentation for implantation. The implant is offered in multiple combinations of bridge lengths, leg lengths, cross sections and cannulated versions to accommodate various anatomies. The system is intended to be used for fracture fixation, osteotomy fixation, and joint arthrodesis of the foot and ankle.

The TMC Hammertoe Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the TMC Hammertoe Fixation System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint). The Implantable K-Wires are indicated for use in fixation of bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, and metatarsophalangeal joint instability.

The Treace Medical Concepts (TMC) Hammertoe Fixation System is for the fixation of osteotomies and reconstruction of the lesser toes. The cannulated implant is made of PEEK (Polyetheretherketone) according to ASTM F2026 and is available in different sizes. The implants are delivered sterile packaged and for single use only. The Implantable K-wire is made from stainless steel according to ASTM F138 and available in different sizes. The k-wire is delivered sterile packaged and for single use only. All implantable components are provided sterile by gamma irradiation.

The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. The system can be used in both and pediatric patients aged > 12 years. In the foot, the system can be used for the following specific examples: - First metatarsal osteotomies for hallux valgus correction such as: - Opening base wedge osteotomy - · Closing base wedge osteotomy - · Crescentic osteotomy - · Proximal Chevron osteotomy - · Distal Chevron osteotomy (Austin) - First metatarsal fracture fixation - Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of - deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and / or arthritis - Flatfoot Osteotomies - · Lateral Column Lengthening (Evans Osteotomy) - · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton - Osteotomy) - Mid / Flatfoot Fusions - · LisFranc Arthrodesis and/or Stabilization - · Intercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - · Talo-Navicular (TN) Fusion - Calcaneo-Cubiod (CC) Fusion - Medial Column Fusion

The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, H- shaped, curved and Python plates and associated screws. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of small bones of the foot. The purpose of this special 510(k) is to clarify the indications for use for the Treace Medical Concepts (TMC) Plating System (K192504 and K200961). All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

The Treace Medical Concepts (TMC) Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid. In the foot, the following specific examples are indicated with screws appropriate for the size of the device: - · mono or bicortical osteotomies - · distal or proximal metatarsal osteotomies - · weil osteotomy - · fusion of the metatarsalphalangeal joint - · fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) - · Akin type osteotomy - · talonavicular fusions - cuboid fusions Not for spinal use.

Treace Medical Concepts (TMC) Screw Fixation System includes headed and headless cannulated screws. The TMC Screw Fixation System is intended for use for adult and pediatric patients aged >12 years, and indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid, appropriate for the size of the device. The purpose of this special 510(k) submission is to add a new non-cannulated screw option known as the Rapid Insertion Implant System. All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.