(233 days)
The Osteo ACL Screw™ is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.
The Osteo ACL Screw™ is not intended for use in and is contraindicated for 1) insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitation and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active separas or infection, 5) Conditions, which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs, which would not be appropriate for fixation with metallic screws.
The implant is composed of mixture of poly-96L/4D-lactide copolymer and tri-calsium phosphate. The predicate devices like Mitek Biocryl Interference Screws (013572) and Biocomposites Ltd Biolok (K993630, K002070) are utilizing mixture of poly-L-lactide and tri-calsium phosphate.
Lengths of implant are 20 30 mm
-Diameters of implant are 7mm-11mm.
The only modifications that were made are:
Amendment of a new raw material option, mixture of poly-961/4D-lactide copolymer and tricalsiumphosphate (TCP).
Design of driver hole is adapted of Linvatec BioScrew implant (K933719, -K952831, K973758).
Thread profile is adjusted to fit with bone taps of Linvatec BioScrew implant -(K933719, K952831, K973758).
Reference numbers for these new screw versions. These changes are updated in labelling.
New trade name to separate it from SmartScrew ACL. This change is updated in labelling.
Revision of insert sheet concerning adaption of instrumentation of BioScrew. -
The provided document is a 510(k) summary for the Linvatec Biomaterials Osteo ACL Screw, an orthopedic device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The 510(k) summary is focused on:
- Device Identification: Trade name, common name, classification, product code.
- Predicate Device Comparison: Listing similar previously cleared devices.
- Intended Use and Contraindications: What the device is for and situations where it should not be used.
- Device Description: Material composition, dimensions, and modifications from previous versions.
- Substantial Equivalence Argument: A statement that the modified device does not raise new safety or efficacy concerns compared to the predicate devices.
There are no acceptance criteria or study results presented in this document concerning performance metrics like accuracy, sensitivity, specificity, or reader improvement with AI assistance, as this is not the purpose of a 510(k) premarket notification.
§ 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.