(53 days)
The LactoSorb® Meniscal Screw is indicated for the repair of vertical longitudinal fullthickness tears (i.e. bucket-handle) in red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.
The LactoSorb® Meniscal Screw is made of bioresorbable and biocompatible polymers that have been used in surgical procedures for years. LactoSorb® resorbable copolymer is synthetic polyester derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs in vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb® material has been found in animal and clinical studies to be biocompatible in both soft tissue and bone tissue.
This document does not contain information about a study proving that the LactoSorb® Meniscal Screw meets specific acceptance criteria in terms of performance.
The provided text is a 510(k) summary for the LactoSorb® Meniscal Screw, which primarily focuses on demonstrating substantial equivalence to a predicate device (LactoSorb® Meniscal Staple, K982095) for regulatory clearance. It describes the device's intended use, materials, and provides the FDA's clearance letter.
Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a performance study.
The only relevant information that can be extracted is:
- Device Name: LactoSorb® Meniscal Screw
- Intended Use: Repair of vertical longitudinal full-thickness tears (i.e., bucket-handle) in red-red and red-white zones of the meniscus. Not to be used for meniscal tears in the avascular zone.
- Predicate Device: LactoSorb® Meniscal Staple (K982095)
- Material: Bioresorbable and biocompatible polymers (LactoSorb® resorbable copolymer, synthetic polyester derived from lactic and glycolic acids).
- Material Evidence: "The LactoSorb® material has been found in animal and clinical studies to be biocompatible in both soft tissue and bone tissue." (This is a general statement about the material, not a specific performance study of the screw device itself.)
§ 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.