(28 days)
Synthes (USA) Patient Specific Cranial/Craniofacial Implant is intended to replace bony voids in the cranial and/or craniofacial skeleton.
The Synthes Patient Specific Cranial/Craniofacial Implant (PSCI) replaces bony voids in the cranial/craniofacial skeleton. Multi-piece implants are preformed / pre-shaped to fit the anatomy of the patient, will range in size from 100 x 100 mm to 350 x 350 mm, and attach to the native bone using standard Synthes cranial and craniofacial plates and screws in sizes 1.3 mm through 2.0 mm. The Synthes Patient Specific Cranial/Craniofacial Implants are manufactured from CP Titanium and PEEK.
This document is a 510(k) summary for the Synthes Patient Specific Cranial/Craniofacial Implant (PSCI). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (i.e., performance metrics, sample sizes, expert ground truth, etc.).
The document is a premarket notification for a medical device which states it is "substantially equivalent" to legally marketed predicate devices. This type of filing relies on demonstrating equivalence to existing devices rather than presenting novel performance studies with detailed acceptance criteria and statistical analysis as might be done for a new technology or higher-risk device.
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information.
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).