(23 days)
Not Found
No
The device description and intended use are for a physical implant (interference screw) and do not mention any software, algorithms, or data processing capabilities that would typically involve AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
A therapeutic device is typically understood to deliver therapy, often with the goal of treating a disease or condition. While the Matryx™ Interference Screw aids in bone and soft tissue graft fixation during ligament reconstructions (which is part of a treatment process), its primary and direct function is mechanical stabilization rather than delivering a therapeutic agent or energy to directly treat a medical condition. It's an implant for structural support, not a device that "performs" therapy itself.
No
The device, an Matryx™ Interference Screw, is used for interference fixation of grafts in ligament reconstructions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states the implant is composed of a mixture of poly-96L/4D-lactide copolymer and tri-calcium phosphate, indicating it is a physical medical device (an interference screw) and not software.
Based on the provided text, the Matryx™ Interference Screw is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "interference fixation of bone-patellar tendon -- bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions." This describes a surgical implant used in vivo (within the body) to fix tissues.
- Device Description: The description details the material composition (poly-96L/4D-lactide copolymer and tri-calsium phosphate) and physical characteristics (lengths and diameters) of a screw designed for surgical implantation.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Matryx™ Interference Screw does not perform any such function.
Therefore, the Matryx™ Interference Screw is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Matryx™ Interference Screw is intended for use in interference fixation of bonepatellar 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 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 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 (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
The implant is composed of mixture of poly-96L/4D-lactide copolymer and tri-" calsium phosphate. The predicate device Osteo ACL Screw is made of the very same raw material.
Lengths of implant are 20 30 mm
Diameters of implant are 7mm-9mm.
The only modifications that were made are:
Change of trade name. This change is updated in labelling.
Minor modifications and further definition of tolerances of screw design.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Ko52080
Special 510(k) Summary Linvatec Biomaterials Matryx™ Interference Screw
Submitter's Name, Address, Telephone Number, and Contact Person
Linvatec Biomaterials Ltd. Tuija Annala Regulatory Affairs Product Director, Quality, and Development P.O.Box 3 FIN-33721 Tampere Finland, Europe 358-3-316 2600 Phone: 358-3-316 5629 Facsimile:
June 30th, 2005 Date prepared:
Name of the device:
| A. | Trade or Proprietary Name: | Matryx™ Interference Screw |
|---|---|---|
| B. | Common Name: | Bioabsorbable Interference Screw |
| C. | Classification Name: | Bone Fixation Screw |
| D. | Device Product Code: | MAI and HWC |
Predicate Device:
-
- Linvatec Biomaterials Ltd Osteo ACL Screw (K032894)
Intended Use:
The Matryx™ Interference Screw is intended for use in interference fixation of bonepatellar 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 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 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 Osteo ACL Screw is made of the very same raw material.
- Lengths of implant are 20 30 mm -
- Diameters of implant are 7mm-9mm. -
The only modifications that were made are:
- Change of trade name. This change is updated in labelling. -
- Minor modifications and further definition of tolerances of screw design. ﮯ
Substantial Equivalence:
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 seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
AUG 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tuija Annala Director, Quality, Regulatory Affairs and Product Development Linvatec Biomaterials Ltd. P.O. Box 3 FIN-33721 Tampere Finland, Europe
Re: K052080
Trade/Device Name: Matryx™ Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MAI Dated: June 30, 2005 Received: August 02, 2005
Dear Ms. Annala:
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 for are warenior 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 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.
3
Page 2 – Ms. Tuija Annala
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maneting your and equivalence of your device to a legally premarket nothcation. THC PDA midning of backannel of 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 If you desire specific advice ion your act (240) 276-0120. Also, please note the regulation entitled, Colliact the Office of Comphalled at (210) = 16 cation" (21CFR Part 807.97). You may obtain " Misoranding by Icrerchec to promaxectionities under the Act from the Division of Small other general Information on your responsibility and its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Acting 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): K052080
Device Name:
Matryx™ Interference Screw
Indications for Use:
The Matryx™ Interference Screw is intended for use in interference fixation of bone-I he Mauryx - Interference Service grafts in anterior and posterior cruciate ligament reconstructions.
The Matryx™ Interference Screw is not intended for use in and is contraindicated for I he Madyx --- Inclierence bereits of bone for attachment of graft, 2) Blood supply I ) Institlelent quanty and quality e, which could retard healing, 3) Foreign body minitiation and/or provious material. Where the material is suspected a test should be sensitivity 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 meetion, 3) Conditions, which tons during the healing and rehabilitation period, 6) Itsurer actryines of Your well over appropriate for fixation with metallic screws.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K052080