(30 days)
The Stryker PEEK Customized Cranial Implant Kit is intended to replace bony voids in the cranial and the craniofacial skeleton.
The Stryker PEEK Customized Cranial Implant Kit is indicated for filling bony voids in the craniofacial skeleton in patients 12 years of age and older.
The Stryker PEEK Customized Cranial Implant (CCI) is intended to replace bony voids in the cranial and the craniofacial skeleton in patients 12 years of age and older. The PEEK CCI product offerings provide customized cranial or craniofacial patient specific implants based on CT data and surgeon input. This special 510(k) is being submitted due to the optional removal of the Host Bone Model from the PEEK CCI Kit which creates the PEEK Customized Cranial Priority Implant product offering, and also the standard PEEK Customized Cranial Implant product offering.
This document is a 510(k) summary for the Stryker PEEK Customized Cranial Implant Kit, K152076. Based on the provided text, the device is a modified version of a previously cleared device (K121153), where the modification involves making the Host Bone Model optional.
As such, the document states that performance data, including bench testing, animal testing, and clinical testing, were NOT required as a basis for substantial equivalence because the modification does not alter the technological characteristics of the actual implant. There are no changes in material, duration or location of contact, or reprocessing methods for the implant itself.
Therefore, the document does not contain specific acceptance criteria or an explicit study proving performance against such criteria for the modified device in the typical sense of a new device clearance. Instead, it relies on the predicate device's clearance and the argument that the core functionality and safety remain unchanged.
Given this, I cannot provide the requested information in the format of acceptance criteria and reported device performance for K152076, nor details about sample sizes, ground truth establishment, or comparative effectiveness studies. The document explicitly states these were not required for this particular submission.
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).