(81 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor and its inserter, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended to reattach soft tissue to bone, stabilize damaged soft tissue, and aid in healing, directly functioning to treat a medical condition.
No
This device is a surgical implant designed to reattach soft tissue to bone, not to diagnose a condition.
No
The device description clearly outlines a physical, implantable suture anchor and a disposable inserter, both of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a suture anchor) used to physically reattach soft tissue to bone during orthopedic procedures. It is a physical device used within the body during surgery, not a device used to analyze samples outside the body.
The description focuses on the mechanical properties, materials, and surgical application of the device, which are characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Y-Knot® All-Suture Anchors are soft-tissue fixation devices with an expandable push-in design, provided preloaded on a flexible disposable inserter for the Y1802 (double-loaded). This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by two suture strands. The flat suture and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The disposable, flexible inserter has a stainless steel shaft supporting the forked shaped tip, with ABS handle, and is provided sterile, for single use. The disposable inserter device is removed at the end of the repair leaving behind an all suture construct. This device differs from the predicate in terms of the number of sutures threaded through its center (two) and in terms of the use of a flexible driver to implant the anchor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgical procedures
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)
The verification and validation testing of the Flexible Y-Knot All-Suture Anchor (Y1802) includes fixation strength / pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life and packaging/transportation.
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
Image /page/0/Picture/1 description: The image shows the text 'K131035 (1/2)'. The text appears to be a code or identifier, possibly related to a document or item. The numbers and parentheses suggest it could be a reference number with a fraction indicating a part or page number. The text is in a simple, clear font.
Image /page/0/Picture/2 description: The image shows the logo for Conmed Linvatec. The logo consists of a stylized graphic on the left, followed by the word "CONMED" in large, bold letters. Below "CONMED" is the word "LINVATEC" in smaller letters. The logo appears to be for a medical or healthcare-related company.
Vincent Boulevard • Largo, FL 33773-4928 • 727-393-6464 • www.llmalac.com
510(k) Summary
JUL 0 2 2013
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: 9 April 2013
A. Submitter
Linvatec Corporation d/b/a ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Joy Lovett Regulatory Affairs Specialist Telephone (727) 399-5137 Fax (727) 399-5264
C. Device Name
Trade Name: Y-Knot Flex All-Suture Anchor, w/ Two #2 (5 Metric) Hi-Fi Sutures, 1.8mm Common Name: Non-absorbable Suture Anchor Classification Names: Fastener, Fixation, Nondegradable, Soft tissue Proposed Class/Device: Class II Product Codes: MBI 21 CFR Part 888.3040 Regulation
D. Predicate/Legally Marketed Devices
| Device Name: | Y-Knot™ All-Suture Anchor |
|---|---|
| Company Name: | Linvatec Corporation d/b/a ConMed Linvatec |
| 510(k) #: | K111779 |
Page 1 of 2
1
Image /page/1/Picture/1 description: The image shows the logo for Conmed Linvatec. The logo is in black and white and features the text "CONMED" in large, bold letters. Below the text is the word "LINVATEC" in smaller letters. To the left of the text is a stylized graphic.
K131035 (2/2)
1311 Concept Boulevard - Largo, FL 33773-4908 - 727-392-6464 - www.linvatec.com
E. Device Description
The Y-Knot® All-Suture Anchors are soft-tissue fixation devices with an expandable push-in design, provided preloaded on a flexible disposable inserter for the Y1802 (double-loaded). This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by two suture strands. The flat suture and the double loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The disposable, flexible inserter has a stainless steel shaft supporting the forked shaped tip, with ABS handle, and is provided sterile, for single use. The disposable inserter device is removed at the end of the repair leaving behind an all suture construct. This device differs from the predicate in terms of the number of sutures threaded through its center (two) and in terms of the use of a flexible driver to implant the anchor.
F. Testing
The verification and validation testing of the Flexible Y-Knot All-Suture Anchor (Y1802) includes fixation strength / pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life and packaging/transportation.
G. Intended Use / Indications
The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or ioint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
H. Substantial Equivalence
The Y-Knot Flex All-Suture Anchor 1.8mm (Y1802) is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ConMed Linvatec Y-Knot® All-Suture Anchor (K111779) while raising no new issues of safety or effectiveness.
Page 2 of 2
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, a symbol often associated with medicine and healthcare.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2013
Linvatec Corporation d/b/a ConMed Linvatec % Ms. Joy Lovett Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773
Re: K131035
Trade/Device Name: Y-KNOT® FLEX ALL-SUTURE ANCHOR, W/TWO #2 (5 metric) HI-FI SUTURES. 1.8mm Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 17, 2013 Received: May 22, 2013
Dear Ms. Lovett:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
3
Page 2 - Ms. Joy Lovett
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
Erining & eith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K131035 510(k) Number (if known): _
Device Name: Y-KNOT® FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 metric) HI-FI SUTURES, 1.8mm
Intended Use / Indications for Use:
The device is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the sulure anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
Prescription Use X (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)
Page 1 of 1
Division of Orthopedic Devices
Module A - Page 13 of 26