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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.

This document is a 510(k) premarket notification for a medical device called the "Treace Medical Concepts (TMC) Compression Screw System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets explicit acceptance criteria based on clinical performance or AI algorithm metrics.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/machine learning performance (e.g., sensitivity, specificity, MRMC studies, ground truth) is not applicable to this document.

This is a traditional medical device (metallic bone fixation fastener) that is cleared based on demonstrating substantial equivalence in terms of:

• Intended Use and Indications for Use: Comparing to predicate devices.
• Material Equivalence: Using medical-grade titanium alloy, similar to predicates.
• Dimensional Equivalence: Comparing screw dimensions to predicates.
• Performance Bench Testing: Specifically, per ASTM F543-13, which is a standard for metallic medical bone fasteners, not AI algorithm performance. This type of testing evaluates mechanical properties like torsional strength, bending strength, etc., relevant to its function as a bone screw.
• Sterilization Validation: Per ISO 11137-2:2006 and endotoxin testing per AAMI ST72:2002/R2010, which are standard for sterile medical devices.

In summary, there is no AI component to this device, and thus no AI-specific acceptance criteria, performance studies, or ground truth establishment as described in your request. The "study" mentioned is bench testing for mechanical properties and standard sterilization/endotoxin validation.

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