(45 days)
Not Found
No
The device description and intended use focus solely on a mechanical soft-tissue fixation device and its associated instruments. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes.
The device is intended to reattach soft tissue to bone and stabilize damaged soft tissue, which directly contributes to the healing process and restoration of function, classifying it as a therapeutic device.
No
Explanation: The Y-Knot™ All-Suture Anchor is a fixation device used to reattach soft tissue to bone in orthopedic surgical procedures. Its purpose is to stabilize damaged soft tissue, not to diagnose medical conditions or diseases.
No
The device description clearly outlines physical components made of stainless steel and ABS, and the intended use involves a surgical procedure with a physical anchor and inserter. This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reattach soft tissue to bone in orthopedic surgical procedures. This is a direct surgical intervention on the body.
- Device Description: The device is a physical implant (suture anchor) and associated surgical instruments used during a surgical procedure.
- 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) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The Y-Knot™ All-Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system 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 Anchor is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter device. This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by one suture strand. The flat suture and the single suture strand are folded back on themselves at the distal end of the disposable inserter. The disposable inserter device has a forked shaped distal end, stainless steel shaft, with an ABS handle, that is provided sterile, for single use and is removed at the end of the repair leaving behind an all suture construct. 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 all-suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The suture anchor configuration is supplied sterile, single use, preloaded onto a disposable driver. The disposable driver is composed of a 300 series surgical grade stainless-steel shaft with an ABS handle. Additional surgical instruments, including a drill bit and drill guides, are Class I, sterile, single-use devices intended for transient use during orthopedic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue to bone (e.g. ligaments, tendons, or joint capsules)
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 Y-Knot™ All-Suture Anchor includes fixation strength, pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life, packaging/transportation and side-by-side comparator qualifications.
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
AUG - 8 2011
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 _ K111779 .
Date Prepared: July 25, 2011
A. Submitter
ConMed Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Regulatory Contact: John Cusack Regulatory Affairs Manager (727) 399-5562 Telephone (727) 399-5264 Fax
C. Device Name
| Trade Name: | Y-Knot™ All-Suture Anchor |
|---|---|
| Common Name: | Non-absorbable Suture Anchor System |
| Classification Name: | Fastener, Fixation, Nondegradable, Soft tissue |
| Proposed Class/Device: | Class II |
| Product Code: | MBI |
| Regulation: | 21 CFR Part 888.3040 |
D. Predicate/Legally Marketed Devices
| Device Name: | ConMed Linvatec Bio Mini Revo |
|---|---|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K053561 |
| Device Name: | ConMed Linvatec Soft Tissue to Bone System |
| Company Name: | ConMed Linvatec |
| 510(k) #: | K091549 |
| Device Name: | Biomet JuggerKnot Soft Anchor |
| Company Name: | Biomet Sports Medicine |
| 510(k) #: | K110145 |
1
E. Device Description
The Y-Knot™ All-Suture Anchor is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter device. This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by one suture strand. The flat suture and the single suture strand are folded back on themselves at the distal end of the disposable inserter. The disposable inserter device has a forked shaped distal end, stainless steel shaft, with an ABS handle, that is provided sterile, for single use and is removed at the end of the repair leaving behind an all suture construct. 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 all-suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The suture anchor configuration is supplied sterile, single use, preloaded onto a disposable driver. The disposable driver is composed of a 300 series surgical grade stainless-steel shaft with an ABS handle. Additional surgical instruments, including a drill bit and drill guides, are Class I, sterile, single-use devices intended for transient use during orthopedic procedures.
F. Testing
The verification and validation testing of the Y-Knot™ All-Suture Anchor includes fixation strength, pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life, packaging/transportation and side-by-side comparator qualifications.
G. Intended Use / Indications
The Y-Knot™ All-Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system 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.
H. Substantial Equivalence
The Y-Knot™ All-Suture Anchor is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ConMed Linvatec Bio Mini Revo (K053561), the ConMed Linvatec Soft Tissue to Bone System (K091549) and the Biomet JuggerKnot Soft Anchor (K110145).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ConMed Linvatec % Mr. John Cusack Regulatory Affairs Manager 11311 Concept Boulevard Shelton, Connecticut 06484
Re: K111779
AUG - 8 2011
Trade/Device Name: Y-Knot™ All-Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: July 26, 2011 Received: July 27, 2011
Dear Mr. Cusack:
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. Iisting 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
3
Page 2 - Mr. John Cusack
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 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,
Mark N. Melker Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
111 779 (1/1)
6. Indications for Use
510(k) Number (if known):
Y-Knot™ All-Suture Anchor Device Name:
Indications for Use:
The Y-Knot™ All-Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system 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.
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 CDRH, Office of Device Evaluation (ODE) M. Mill (Division Sign-Oft) (Division Sign-Off)
Division of Surgical, Of Surgical, Ofthopedic, Division of Sale
and Restorative Devices
510(k) Number
18