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Synthes Resorbable Fixation System devices (Plates, Meshes, Screws and Tacks), are intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton.

In addition, Resorbable Meshes, Sheets, Screws, and Tacks may be used in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft) or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.

Synthes Resorbable Contourable Mesh is a resorbable material sheet that comes in various sizes and shapes in perforated patterns that allow for better anatomical conformity. It is a part of the Synthes Resorbable Fixation System and can be used with the screws, tacks, and instruments in that system.

This document is a 510(k) summary for the Synthes Resorbable Contourable Mesh. It establishes substantial equivalence to existing devices and does not contain information about a device that uses artificial intelligence or machine learning. Therefore, a study proving the device meets acceptance criteria, an acceptance criteria table, sample sizes, ground truth establishment methods, or information about MRMC comparative effectiveness studies are not present in this document.

The document primarily focuses on:

• Device Name: Resorbable Contourable Mesh
• Submitter: Synthes (USA)
• Classification: Class II, Bone Plate (21 CFR §872.4760)
• Predicate Device: Other legally marketed devices, establishing substantial equivalence.
• Device Description: A resorbable material sheet in various sizes and shapes with perforated patterns for anatomical conformity. Part of the Synthes Resorbable Fixation System.
• Intended Use: Fracture repair and reconstructive procedures of the craniofacial skeleton; managing bony fragments, bone grafts, or bone graft substitutes in non-load bearing craniofacial or mandibular areas.
• Contraindications: Not for full load-bearing applications (e.g., mandible alone), areas with infection, limited blood supply, insufficient bone quality/quantity, or spinal use.
• Material: Poly(L/DL-lactide)

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