(74 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities. There is no mention of AI, ML, image processing, or data analysis.
No
The device is a non-absorbable suture anchor intended to reattach soft tissue to bone, which stabilizes the damaged soft tissue, but it does not directly treat a disease or improve health.
No
Explanation: The device is a suture anchor intended for reattaching soft tissue to bone in orthopedic surgical procedures, not for diagnosing conditions.
No
The device description clearly outlines physical components made of stainless steel and polycarbonate, and the performance studies include testing related to physical properties like fixation strength and cyclic loading. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "reattach[ing] soft tissue to bone in orthopedic surgical procedures." This is a surgical intervention performed directly on the patient's body.
- Device Description: The description details a physical implantable device (suture anchors) and an inserter used during surgery.
- 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 in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Y-Knot All-Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.
Product codes
MBI
Device Description
The Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures are soft-tissue fixation devices with an expandable push-in design, provided preloaded on a disposable inserter. The suture anchors are constructed of a flat suture that is interlaced longitudinally along its central width by double and triple suture strands. The flat suture and the double and tripled loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The disposable inserter has a stainless steel shaft supporting the forked shaped tip, and a polycarbonate handle. The disposable inserter device is removed at the end of the repair leaving behind an all suture construct. The finished device is provided sterile, for single use.
The Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures features both surgical techniques for self-punching and pre-drill pilot hole insertion.
A breakdown of catalog numbers, description and suture configuration is included in Table 1.
| Catalog
| Number | Description | Suture Configuration |
|---|---|---|
| YRC02 | Y-Knot® RC All-Suture Anchor w/two | |
| #2 Hi-Fi® | 1 Blue and 1 White/Black | |
| YRC03 | Y-Knot® RC All-Suture Anchor w/three | |
| #2 Hi-Fi® | 1 Blue, 1 White/Black and 1 | |
| White/Blue | ||
| YRC02A | Y-Knot® RC All-Suture Anchor w/two | |
| #2 Hi-Fi® | 1 White/Black and 1 White/Blue | |
| YRC03A | Y-Knot® RC All-Suture Anchor w/three | |
| #2 Hi-Fi® | 1 White/Black, 1 White/Blue and | |
| 1 White |
Table 1 : Y - Knot® RC All-Suture Anchors
The Y-Knot® RC All-Suture Anchors are inserted using the following instrumentation.
| Catalog Number | Description |
|---|---|
| Y28D | Y-Knot® RC Disposable Drill Bit, 2.8mm |
| Y-DBP28 | Y-Knot® RC Disposable Broaching Punch, 2.8mm |
| Y-BP28 | Y-Knot® RC Broaching Punch, 2.8mm |
| Y-DGRC | Y-Knot® RC Drill Guide |
| Y-OBRC | Y-Knot® RC Drill Guide Obturator |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue to 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 Y-Knot® RC All-Suture Anchor w/two and three #2 Hi-Fi® Sutures includes fixation strength / pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life and packaging/transportation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a stylized "C" shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font.
JAN - 3 2014
510(k) Summary
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) Number
Date Prepared: December 31, 2013
A. Submitter
ConMed Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294
B. Company Contact
Nyrobia Freeman Regulatory Affairs Specialist Telephone (727) 399-5416 (727) 399-5264 Fax
C. Device Name
| Trade Name: | Y-Knot® RC All-Suture Anchor w/Two and Three #2
Hi-Fi® Sutures |
|------------------------|-------------------------------------------------------------------|
| Common Name: | Non-absorbable Suture Anchor |
| Classification Names: | Fastener, Fixation, Nondegradable, Soft tissue |
| Proposed Class/Device: | Class II |
| Product Codes: | MBI |
| Regulation | 21 CFR Part 888.3040 |
D. Predicate/Legally Marketed Devices
| Device Name: | Y-Knot® Flex All-Suture Anchor, w/two #2 (5 Metric) |
|---|---|
| HI-FI® Suture, 1.8mm | |
| Company Name: | Linvatec Corporation d/b/a ConMed Linvatec |
| 510(k) #: | K131035 |
1
Image /page/1/Picture/1 description: The image shows the logo for CONMED Corporation. The logo consists of a stylized graphic to the left of the word "CONMED" in large, bold letters. Below "CONMED" is the word "CORPORATION" in smaller letters. The graphic is a curved shape, possibly representing a medical device or tool.
E. Device Description
The Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures are soft-tissue fixation devices with an expandable push-in design, provided preloaded on a disposable inserter. The suture anchors are constructed of a flat suture that is interlaced longitudinally along its central width by double and triple suture strands. The flat suture and the double and tripled loaded suture strands are folded back on themselves at the distal end of the disposable inserter. The disposable inserter has a stainless steel shaft supporting the forked shaped tip, and a polycarbonate handle. The disposable inserter device is removed at the end of the repair leaving behind an all suture construct. The finished device is provided sterile, for single use.
The Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures features both surgical techniques for self-punching and pre-drill pilot hole insertion.
A breakdown of catalog numbers, description and suture configuration is included in Table 1.
| Catalog
| Number | Description | Suture Configuration |
|---|---|---|
| YRC02 | Y-Knot® RC All-Suture Anchor w/two | |
| #2 Hi-Fi® | 1 Blue and 1 White/Black | |
| YRC03 | Y-Knot® RC All-Suture Anchor w/three | |
| #2 Hi-Fi® | 1 Blue, 1 White/Black and 1 | |
| White/Blue | ||
| YRC02A | Y-Knot® RC All-Suture Anchor w/two | |
| #2 Hi-Fi® | 1 White/Black and 1 White/Blue | |
| YRC03A | Y-Knot® RC All-Suture Anchor w/three | |
| #2 Hi-Fi® | 1 White/Black, 1 White/Blue and | |
| 1 White |
Table 1 : Y - Knot® RC All-Suture Anchors
The Y-Knot® RC All-Suture Anchors are inserted using the following instrumentation.
| Catalog Number | Description |
|---|---|
| Y28D | Y-Knot® RC Disposable Drill Bit, 2.8mm |
| Y-DBP28 | Y-Knot® RC Disposable Broaching Punch, 2.8mm |
| Y-BP28 | Y-Knot® RC Broaching Punch, 2.8mm |
| Y-DGRC | Y-Knot® RC Drill Guide |
| Y-OBRC | Y-Knot® RC Drill Guide Obturator |
Table 2: Description of Instrumentation
2
Image /page/2/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a stylized "C" shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. The logo is black and white.
F. Testing
The verification and validation testing of the Y-Knot® RC All-Suture Anchor w/two and three #2 Hi-Fi® Sutures includes fixation strength / pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life and packaging/transportation testing.
G. Intended Use / Indications
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The Y-Knot All-Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.
H. Substantial Equivalence
The Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® are substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicate ConMed Linvatec Y-Knot® Flex All-Suture Anchor, w/two #2 (5 Metric) HI-FI® Suture, 1.8mm and raises no new issues of safety or effectiveness.
3
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
January 3, 2014
ConMed Corporation Ms. Nyrobia Freeman Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773
Re: K133224
Trade/Device Name: Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 20, 2013 Received: December 23, 2013
Dear Ms. Freeman:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 – Ms. Nyrobia Freeman
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" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ronalding Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _K133224
Device Name: Y-Knot® RC All-Suture Anchor w/Two and Three #2 Hi-Fi® Sutures
INTENDED USE
The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.
INDICATIONS FOR USE
The Y-Knot All-Suture Anchors may be used in either arthroscopic or open surgical procedures. After the suture strands are anchored to the bone, they may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. In conjunction with appropriate postoperative immobilization throughout the healing period, the suture anchor systems stabilize the damaged soft tissue.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Picture/12 description: The image shows the words "Casey L. Hanley, Ph.D." on the top line, followed by a horizontal line. The second line says "Division of Orthopedic Devices". The text is in a simple, sans-serif font and is easy to read.