Search Results

The Matryx™ Interference 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 Matryx™ Interference 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 limitations 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 sepsis 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 device previously cleared Matryx Interference Screw is made of the very same raw material.
Lengths of implant are 25 38 mm .
Diameters of implant are 9 mm-11mm. .

The only modifications that were made are:
Amendment of a new screw sizes. -
Thread profile for longer 9 mm screw is similar with already cleared Matryx™ ... Interference Screws (K052080). The thread profile of diameter 10 mm and 11 mm screws is similar with predicate device ConMed Linvatec BioScrew (K933719, K952831, K973758)
Amendment of Bone Taps for screws of 9 mm x 38 mm, 10 mm and 11 mm. -
Reference numbers for these new screw versions. These changes are updated in . labelling.
Revision of insert sheet covering the new screw sizes. -

This document describes a 510(k) premarket notification for the ConMed Linvatec Biomaterials Matryx™ Interference Screw. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not found in this type of regulatory document.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission does not include a table of acceptance criteria or reported device performance in the way a clinical study report would. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, meaning it has the same intended use, technological characteristics, and safety and effectiveness.

The document states:

• "The applied modifications do not raise any new concerns of safety and efficacy of the implant."
• The device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

This implies that the acceptance criterion for a 510(k) is meeting the substantial equivalence requirements to the predicate devices, rather than predefined performance metrics from a new standalone study.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. This 510(k) submission does not describe a "test set" in the context of an algorithm or a clinical study for performance evaluation that would require a sample size or data provenance details. The submission is a regulatory filing for a medical device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This document does not pertain to the evaluation of an algorithm or diagnostic device where expert ground truth would be established for a test set.

4. Adjudication Method for the Test Set

Not Applicable. There is no "test set" or adjudication method described in this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done, as this document is a 510(k) premarket notification for a physical medical device (an interference screw), not an AI or diagnostic algorithm where human reader performance would be a relevant metric.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is not a submission for an algorithm or software device.

7. The Type of Ground Truth Used

Not Applicable. As this is a 510(k) for a physical implant, the concept of "ground truth" as typically used for diagnostic algorithms or imaging interpretation studies does not apply. The "truth" in this context is the safety and effectiveness of the device, which is established by demonstrating substantial equivalence to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" described in this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. There is no "training set" or establishment of ground truth for such a set in this 510(k) submission.

Ask a specific question about this device