(134 days)
The plate designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including, but not limited to cranial bone fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
The Bioplate Fixation System is manufactured of commercially pure titanium and a titanium 6AI - 4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.) The plates are substantially equivalent in construction and design to the predicate devices manufactured by Howmedica, Medicon, KLS and W.L. Lorenz.
This document is a 510(k) summary for the Bioplate Fixation System, which is a rigid bone plating system for craniomaxillofacial surgery.
Based on the provided text, the device is not an AI/ML powered device, nor does it seem to be an imaging or diagnostic device. Therefore, the requested information regarding acceptance criteria, study details (sample sizes, ground truth, expert involvement, MRMC studies, standalone performance), and training set details are not applicable to this submission.
The 510(k) summary only states:
- The device is made of commercially pure titanium and titanium 6AI - 4V ELI alloy.
- These materials have been implanted safely for many years and are recognized as acceptable for implantation through device classification (e.g., 21 CFR sections 888.3030).
- The plates are "substantially equivalent in construction and design" to predicate devices manufactured by Howmedica, Medicon, KLS, and W.L. Lorenz.
The FDA's letter confirms substantial equivalence to pre-amendment devices, subject to general controls and GMP regulations. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than new clinical trials with specific performance metrics against acceptance criteria in the way a novel diagnostic or AI device might.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.