Search Results

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.

The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the system can be used in both adult and pediatric patients. 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 first metatarsalcuneiform joint (Lapidus Fusion) - 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 - 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions - Intercuneiform Fusions - Navicular-Cuneiform (NC) Fusion - Talo-Navicular (TN) Fusion - Calcaneo-Cubiod (CC) Fusion - Medial Column Fusion - Arthrodesis of the first metatarsophalangeal joint (MTP)

The previously cleared Treace Medical Concepts (TMC) Plating System includes straight, Lshaped, H- shaped, and Python plates and 2.5mm-3.0mm diameter screws in lengths ranging from 10-32mm. 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) submission is to add the Lapiplasty® Mini-Incision™ Plates to the TMC Plating System. The subject plates are based on the design of the previously cleared Lapiplasty® S1 Plate (K192504). The subject plates are used with the same screws as the predicate plate. All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-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 small bones of the feet. The system can be used in both adult and pediatric patients. 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 first metatarsalcuneiform joint (Lapidus Fusion) - 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 - · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions - · Intercuneiform Fusions - · Navicular-Cuneiform (NC) Fusion - · Talo-Navicular (TN) Fusion - Calcaneo-Cubiod (CC) Fusion - Medial Column Fusion - Arthrodesis of the first metatarsophalangeal joint (MTP)

The previously cleared Treace Medical Concepts (TMC) Plating System includes straight, Lshaped, and H- shaped , and Python plates and 2.5mm diameter screws in lengths ranging from 10-28mm. 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) submission is to expand the size ranges offered for the plates and screws, as well as add a curved plate option. All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

The Treace Medical Concepts, Inc (TMC) Snap-Off Screw System is intended for use for adult and pediatric patients, as 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, 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 - fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) - Akin type osteotomy Not for spinal use.

The Treace Medical Concepts, Inc (TMC) Snap -Off Screw System includes self-drilling and selftapping screws provided in diameters of 2.0mm (lengths 10mm-20mm) and 2.7mm(lengths 8mm-20mm). The screws are composed of titanium alloy conforming to ASTM F136.

The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the system can be used in both adult and pediatric patients. 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 first metatarsalcuneiform joint (Lapidus Fusion) - 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 - · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions - · Intercuneiform Fusions - · Navicular-Cuneiform (NC) Fusion - · Talo-Navicular (TN) Fusion - Calcaneo-Cubiod (CC) Fusion - Medial Column Fusion - Arthrodesis of the first metatarsophalangeal joint (MTP)

This traditional 510(k) is to obtain clearance for expanded indications for the Treace Medical Concepts (TMC) Plating System implants. The subject TMC Plating System implants include a variety of previously cleared bone plates and screws. The plates and screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F136.

The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. 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 first metatarsalcuneiform joint (Lapidus Fusion) - -- 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 - · 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 Fusion - -- Arthrodesis of the first metatarsophalangeal joint (MTP)

The previously cleared Treace Medical Concepts, Inc (TMC) Plating System includes the PYTHON® plate. The PYTHON® Plate is a curved plate available in both left and right configurations. The plate is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. This submission adds re-usable device specific trial instruments as Class II Instruments (the subject device) to this system. The trial instruments are manufactured from Titanium alloy conforming to ASTM F136.

The Treace Medical Concepts (TMC) Compression Screw System is intended for use for adult and pediatric patients, as 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, metatarsals, 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.

The Treace Medical Concepts (TMC) Compression Screw System includes headed and headless cannulated screws, lengths 10mm (2mm increments up to 50mm, then 5mm increments). The diameters are 2.0mm to 7.5mm increments) and 3.3mm. The TMC Compression Screw System is intended for use for adult and pediatric patients, as 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 medical grade titanium alloy (Ti6Al4V-ELI; hereafter called Ti-6-4) and anodized.

The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the Simex Negative Pressure Wound Therapy Pumps (K113291) for the application of negative pressure wound therapy to the wound. When used in conjunction with the Simex Negative Pressure Wound Therapy Pumps, the Theia NPWT Foam Wound Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris. The Theia NPWT Foam Wound Dressing Kit is appropriate for use on the following wounds; - Pressure Ulcers - · Diabetic/Neuropathic Ulcers - Venous Insufficiency Ulcers - · Traumatic Wounds - · Post-Operative and Dehisced Surgical Wounds - · Skin Flap and Grafts

The Theia NPWT Foam Wound Dressing Kit without the pump includes a foam dressing composed of a reticulated flexible polyether based polyurethane hydrophobic foam material, an occlusive drape and silicon suction dome with negative pressure tubing. Theia NPWT Foam Wound Dressing Kits are available in three sizes; 1) small, 2) medium and 3) large.