(92 days)
Not Found
No
The device description and intended use focus on a physical implant (interference screw) and its material composition and dimensions. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The modifications described are physical changes to the screw size and thread profile.
Yes
The device is described as an "Interference Screw" intended for "interference fixation of bone - patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions," which clearly indicates its use in treating a medical condition or injury.
No
The device is an interference screw used for fixation of grafts in ligament reconstructions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states the device is an implant composed of a mixture of poly-96L/4D-lactide copolymer and tri-calsium phosphate, and describes its physical dimensions (lengths and diameters). This indicates it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "interference fixation of bone - patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as an "implant" composed of specific materials and having physical dimensions (lengths and diameters). This is consistent with a surgical implant, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a surgical implant used to physically fix grafts within the body.
N/A
Intended Use / 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 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.
Product codes
MAI, HWC
Device Description
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 9-11mm. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052080, K933719, K952831, K973758
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
2
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
3
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
4
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