(159 days)
A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:
- Comminuted fractures of the naso-ethmoidal infraorbital areas
- Comminuted fractures of the frontal sinus wall
- Pediatric midface or craniofacial trauma
- LeFort (I,II,III) fractures
- Orbital floor fractures
- Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones
- Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
B. General Indication: reconstructive procedures of the midface or craniofacial skeleton Specific Indications: - Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
- LeFort (I,II,III) osteotomies
- Tumor reconstruction in midface or craniofacial procedures
- Bone graft procedures in the midface or craniofacial skeleton
- Pediatric reconstructive procedures
- Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
- Craniotomy flap fixation
The devices are made of LactoSorb®, which is comprised of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. The LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs In Vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found to be biocompatible in animal and clinical studies in both soft tissue and bone tissue. Additional designs have been added to the system which pose no new risks regarding safety and effectiveness.
The provided text describes the LactoSorb® Trauma Plating System and its indications for use, along with an FDA 510(k) clearance letter. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document is a summary of safety and effectiveness submitted for 510(k) clearance, which primarily focuses on demonstrating substantial equivalence to a predicate device already on the market. It states the device materials are bioresorbable and biocompatible, having been used in surgical procedures for years, and that the material "has been found to be biocompatible in animal and clinical studies in both soft tissue and bone tissue." The FDA letter confirms the 510(k) clearance based on substantial equivalence.
Therefore, I cannot provide details on the requested information regarding acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.