(92 days)
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.
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K063588 Page 142
510(k) Summary ConMed Linvatec Biomaterials Matryx™ Interference Screw
MAR 0 2 2007
Submitter's Name, Address, Telephone Number, and Contact Person
ConMed Linvatec Biomaterials Ltd. Päivi Mesiranta Regulatory Specialist P.O.Box 3 FIN-33721 Tampere Finland, Europe Phone: 358-3-316 5600 Facsimile: 358-3-316 5688
October 4th, 2006 Date prepared:
Classification Name:
Device Product Code:
Name of the device:
- A. Trade or Proprietary Name: Matryx™ Interference Screw
- B. Common Name:
Bioabsorbable Interference Screw Bone Fixation Screw MAI and HWC
Predicate Device:
- l ConMed Linvatec BioScrew (K933719, K952831, K973758), ConMed Linvatec Biomaterials Matryx™ Interference Screw (K052080)
Intended Use:
ﺰ
D.
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.
{1}------------------------------------------------
Device Description:
The device description of the Matryx™ Interference Screw is as follows.
- 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. -
Substantial Equivalence:
ConMed Linvatec Biomaterials Ltd Matryx Interference Screw is substantially equivalent to the cleared predicate device. The applied modifications do not raise any new concerns of safety and efficacy of the implant.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ConMed Linvatec Biomaterials Ltd % Ms. Päivi Mesiranta Regulatory Specialist P.O. Box 3 FIN-33721 Tampere Finland, Europe
MAR 0 2 2007
Re: K063588 Trade/Device Name: Matryx™ Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 6, 2006 Received: January 16, 2007
Dear Ms. Mesiranta:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 – Ms. Päivi Mesiranta
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or 240-276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Mark A. Miller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(K) Number (if known):
Device Name:
Matryx TM Interference Screw
Indications for Use:
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 1) insurrelons 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
Prescription Use V
No Over-The-Counter Use_ ਼ਸ
(Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mah A. Mullan
Division of General, Restorative, and Neurological Devices
) Number K063588
§ 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.