(119 days)
Not Found
No
The device description focuses on the material composition and mechanical properties of a bioabsorbable screw for orthopedic fixation. There is no mention of AI, ML, image processing, or data analysis capabilities.
No
The device, an orthopedic interference screw, is used for surgical fixation of soft tissue to bone and is resorbed over time. It is not designed to treat a disease or condition in the traditional sense of therapy, but rather to provide mechanical support during healing.
No
The device is described as an interference screw used for attaching soft tissue to bone in orthopedic surgical procedures; it is a therapeutic/fixation device, not a diagnostic one.
No
The device description clearly states it is a physical, bioabsorbable interference screw made of specific materials, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, the Genesys Matryx™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "attaching soft tissue to bone in orthopedic surgical procedures." This is a surgical implant used directly in the body during a procedure.
- Device Description: The description details a "threaded, cannulated, bioabsorbable interference screw" made of specific materials, designed for mechanical fixation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The Genesys Matryx™ is an implantable medical device used within the body for structural support and fixation.
N/A
Intended Use / Indications for Use
The Genesys Matryx™ is for attaching soft tissue to bone in orthopedic surgical procedures. Genesys Matryx™ is intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.
Product codes
HWC
Device Description
The Genesys Matryx is a threaded, cannulated, bioabsorbable interference screw composed of ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and betatricalcium phosphate (ß-TCP). The Genesys Matryx maintains accurate position of a tendon/ligament graft. The manufacturing process preserves the high initial mechanical strength and stiffness, which allows secure fixation, in combination with appropriate immobilization/controlled mobilization until clinical determination of healing. The Genesys Matryx completes resorption within several years. Resorption also depends on patient variables. The Genesys Matryx need not be removed prior to revision surgery, if such is needed. The Genesys Matryx is sterile and non-collagenous.
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)
Non-clinical testing was submitted to aid in the characterization of the Genesys Matryx device and to support a determination of substantial equivalence. This testing included in vivo animal testing, in vitro degradation, shelf life, transportation and distribution, verification by analysis, insertion, pullout, cyclic (reliability) and bioburden testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K032894, K052080, K060830, K071091
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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Image /page/0/Picture/1 description: The image shows the logo for Conmed Linvatec. The logo consists of a stylized swoosh shape on the left, followed by the text "CONMED" in bold, sans-serif font. Below the text is the word "LINVATEC" in a smaller font. The address "11311 Concept Boulevard, Largo, FL 33773" is printed below the logo.
711 Concept Boulevard • Largo, FL 33773-4908 • 727-392-6464 • www.limatec.com
@EC 2 | 2010
5. 510(k) Summary
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number_
Date Prepared: December 2, 2010
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Regulatory Contact: Ashlea Bowen Regulatory Affairs Specialist (727) 399-5564 Telephone (727) 399-5264 Fax
C. Device Name
| Trade Name: | Genesys Matryx™ |
|---|---|
| Common Name: | Bioabsorbable Interference Screw |
| Classification Name: | Biodegradable soft tissues fixation fastener |
| Proposed Class/Device: | Class II |
| Product Code: | HWC |
| Regulation: | 21 CFR Part 888.3040 |
D. Predicate/Legally Marketed Devices
| Device Name: | Osteo ACL Screw |
|---|---|
| Company Name: | Linvatec Biomaterials Ltd. |
| 510(k) #: | K032894 |
| Device Name: | Matryx Interference Screw |
| Company Name: | Linvatec Biomaterials Ltd. |
| 510(k) #: | K052080 |
| Device Name: | MILAGRO Interference Screw |
| Company Name: | Depuy Mitek |
| 510(k) #: | K060830 |
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Image /page/1/Picture/1 description: The image shows the logo for Conmed Linvatec. The logo consists of a stylized "C" shape on the left, followed by the word "CONMED" in large, bold letters. Below the word "CONMED" is the word "LINVATEC" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.
11311 Concept Boulevard • Largo, FL 33773-4908 • 727-392-6464 • www.linvatec.com
Device Name: Company Name: 510(k) #:
Bilok Screw Biocomposites Ltd K071091
E. Device Description
The Genesys Matryx is a threaded, cannulated, bioabsorbable interference screw composed of ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and betatricalcium phosphate (ß-TCP). The Genesys Matryx maintains accurate position of a tendon/ligament graft. The manufacturing process preserves the high initial mechanical strength and stiffness, which allows secure fixation, in combination with appropriate immobilization/controlled mobilization until clinical determination of healing. The Genesys Matryx completes resorption within several years. Resorption also depends on patient variables. The Genesys Matryx need not be removed prior to revision surgery, if such is needed. The Genesys Matryx is sterile and non-collagenous.
F. Intended Use / Indications
The Genesys Matryx™ is for attaching soft tissue to bone in orthopedic surgical procedures. Genesys Matryx™ is intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.
G. Substantial Equivalence
The Genesys Matryx substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the Linvatec Biomaterials Ltd Osteo ACL Screw (K032894), the Linvatec Biomaterials Matryx Interference Screw (K052080), the Depuy Metik MILAGRO Interference Screw (K060830), and the Biocomposites Ltd. Bilok Screw (K071091).
H. Non-Clinical Testing
Non-clinical testing was submitted to aid in the characterization of the Genesys Matryx device and to support a determination of substantial equivalence. This testing included in vivo animal testing, in vitro degradation, shelf life, transportation and distribution, verification by analysis, insertion, pullout, cyclic (reliability) and bioburden testing.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
ConMed Linvatec % Ms. Ashlea Brown Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773
Re: K102410
DEC 2 1 2010
Trade/Device Name: Genesys MatryxTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 1, 2010 Received: December 2, 2010
Dear Ms. Brown:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Ashlea Brown
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Acing B. n
fr.
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Conmed Linvatec. The logo consists of a stylized white crescent shape on the left, followed by the word "CONMED" in bold, black capital letters. Below "CONMED" is the word "LINVATEC" in smaller, black capital letters. The logo appears to be for a medical technology company.
1311 Concept Boulevard • Largo, FL 33773-4908 • 727-392-6464 • www.lluviaetc.com
4. Indications for Use
DEC 2 1 2010
1/02410 (pg 1/1) 510(k) Number (if known):
Device Name: Genesys Matryx ™
Indications for Use:
The Genesys Matryx™ is for attaching soft tissue to bone in orthopedic surgical procedures. Genesys Matryx™ is intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.
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 IF NEEDED)
| Concurrence of CDRN, Office of Device Evaluation (ODE) | for M. Mckerson |
|---|---|
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K102440 |