(90 days)
Internal fixation devices to aid the surgeon in the stabilization and fixation of oral micinal "itsanon" do recess" to "all bones of the hand, feet, wrist, ankles, fingers and toes, Craino-maximonomics, osteotomies, revision procedures, joint fusion and reconstructive procedures.
The self drilling screws are 1.5 mm to 2.0 mm in diameter and the thread lengths may range up The son urining become are the we ar cross drive. The tip of the screw is designed so that a predrilled hole is not required, but may be used.
The provided document describes a medical device, the Lorenz Self Drilling Screw, and its intended use, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
The document primarily focuses on:
- Description of the Device: Lorenz Self Drilling Screw sizes, material, and self-drilling feature.
- Intended Use: Internal fixation for various bone stabilization and fixation procedures in specific anatomical regions (oral, cranio-maxillofacial, small bones of hand, feet, wrist, ankles, fingers, toes).
- Sterility: Marketed as non-sterile, single-use, with steam sterilization recommendations.
- Substantial Equivalence: Comparison to previously cleared devices (Synthes 1.3MM Self Drilling Screw, Osteomed Corp. Auto-Drive Bone Screw, KLS Martin L.P. Centre-Drive Drill Free Screw) to demonstrate its equivalence for regulatory purposes.
- Possible Risks: A list of potential complications associated with the device and surgical procedures.
- FDA Clearance Letter: A letter from the FDA confirming the device's substantial equivalence to predicate devices and granting marketing authorization under the Federal Food, Drug, and Cosmetic Act.
No information is provided regarding:
- Acceptance Criteria Table and Reported Device Performance: There is no mention of specific quantitative or qualitative acceptance criteria (e.g., strength, torque, biological response thresholds) that the device must meet, nor any performance data from tests.
- Study Details: There is no description of any study, clinical or non-clinical, that would assess the device's performance against predefined criteria. Therefore, details such as sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment are absent.
- Training Set Sample Size and Ground Truth: Since no study is described to evaluate the device, there is no mention of training sets or how their ground truth would be established.
The document serves as a regulatory submission (510(k)) to demonstrate substantial equivalence, which often relies on comparison to predicate devices that have already established safety and effectiveness. It does not typically require novel performance studies for the device itself unless there are significant technological differences or new indications that cannot be supported by existing predicate data.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.