(421 days)
The Bioplate Resorbable Bone Plating System is intended for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for craniomaxillofacial indications in which resorbable fixation is desired. Plates and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.
The resorbable plates and screws are intended for minimally load bearing fixation for the following indications:
- . Craniofacial fractures
- Reconstructive procedures of the craniomaxillofacial skeleton .
- Cranial bone fixation .
- . Brow lift procedures
The Bioplate® Resorbable Bone Plating System for Craniomaxillofacial Surgery consists of a variety of plate, mesh, and screw configurations intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton in which bioresorbable fixation is desired. Plates, mesh and screws are used to align and stabilize fractures of bony tissue while normal tissue healing occurs.
The plates, mesh, and screws are manufactured of a bioresorbable Poly(L-lactide) copolymer which resorbs by hydrolysis into lactic acids that are metabolized by the body. The material is substantially equivalent to that currently being used in fixation devices and is, in some cases, the exact same copolymer material.
Bioplate® resorbable plates, mesh, and screws are provided sterile by gamma radiation and must not be resterilized.
The provided text is a 510(k) summary for a medical device (Bioplate® Resorbable Bone Plating System) seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The document primarily focuses on demonstrating substantial equivalence based on:
- Intended Use: Similar to predicate devices for craniomaxillofacial surgery.
- Design: Similar plate, mesh, and screw configurations.
- Dimensions: Implied similarity.
- Materials: Poly(L-lactide) copolymer, deemed substantially equivalent to materials in other resorbable fixation systems (e.g., poly(L-lactide-co-glycolide), poly(L/DL-lactide)).
- Sterilization: Gamma radiation.
The 510(k) process is a premarket notification requirement that aims to demonstrate that the new device is at least as safe and effective as a legally marketed predicate device. It typically relies on direct comparison, and extensive clinical trials or performance studies with defined acceptance criteria are often not required if substantial equivalence can be shown through other means (e.g., material testing, mechanical testing, design similarities).
Therefore, I cannot provide the requested information as it is not present in the given text. The document is about regulatory approval through substantial equivalence, not about performance against specific acceptance criteria in a study.
§ 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.