(114 days)
No
The document describes a mechanical surgical fixation system and does not mention any AI or ML components or capabilities.
No
The device is a surgical fixation system used to stabilize bones or soft tissues during orthopedic procedures, which directly addresses a medical condition by providing a physical remedy.
No
The device is described as a fixation system for bone-to-bone or soft-tissue-to-bone fixation, specifically an all-suture suspension device. Its purpose is to physically fixate anatomical structures rather than to diagnose medical conditions or analyze data for diagnostic purposes.
No
The device description clearly outlines physical components such as suture, buttons, a loader, a drill, and a pin, indicating it is a hardware-based 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 for fixation of bone-to-bone or soft-tissue-to-bone in orthopedic surgical procedures. This is a surgical device used in vivo (within the body) for structural support.
- Device Description: The description details a physical implantable device (suture, button, backstop) and associated surgical tools (drill, pin). This is consistent with a surgical implant system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is mechanical fixation, not diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Intended Use
The MicroLink™ All-Suture Button Fixation System, when used for fixation of bone-to-bone or soft-tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Indications for Use
The CONMED MicroLink All-Suture Button Fixation System is indicated for fixation of bone-to-bone as an adjunct in the following orthopedic surgical procedures:
Procedure: Carpometacarpal Suspension
Anatomic Location: Hand
Product codes
HTN
Device Description
The MicroLink™ All-Suture Button Fixation System (Radiopaque) is an all-suture suspension device with one strand of #2 (5 metric) Hi-Fi® suture, a radiopaque flat braid Hi-Fi® Suture Button and a radiopaque flat braid Hi-Fi® suture Backstop threaded on a Loader. A suture passing drill is provided with a nitinol loop for passing. A trapezium pin is provided to facilitate manipulation of the trapezium during trapeziectomy. All four catalog numbers are provided sterile, intended for single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
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)
Testing has been completed to demonstrate that the MicroLinkTM All-Suture Button Fixation System (Radiopaque) performs as intended and is substantially equivalent to the predicate device. Bacterial endotoxin testing was conducted and met the endotoxin limits.
Completed testing includes the following:
Verification Testing
- Sterilization
- Reliability
- Pyrogen
- Packaging
- Transportation
Validation Testing
- Ultimate Fixation Strength
- Side-by-Side Testing
- Biocompatibility
- Shelf-life
- Cyclic
- User Validation
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the acronym "FDA" followed by the words "U.S. Food & Drug Administration".
CONMED Corporation Diana Nader-Martone Senior Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773
Re: K190582
Trade/Device Name: MicroLink™ All-Suture Button Fixation System (Radiopaque) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: May 28, 2019 Received: May 29, 2019
Dear Ms. Nader-Martone:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
MicroLink™ All-Suture Button Fixation System (Radiopaque)
Indications for Use (Describe)
Intended Use
The MicroLink™ All-Suture Button Fixation System, when used for fixation of bone-to-bone or soft-tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Indications for Use
The CONMED MicroLink All-Suture Button Fixation System is indicated for fixation of bone-to-bone as an adjunct in the following orthopedic surgical procedures:
Procedure Carpometacarpal Suspension Anatomic Location Hand
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white curved shape inside on the left. To the right of the square is the word "CONMED" in black, with a blue line underneath. Below the line is the word "CORPORATION" in smaller, black letters.
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 K190582.
I. SUBMITTER
CONMED Corporation 11311 Concept Blvd Largo, Florida 33773
Phone: 727-399-5425 Fax: 727-399-5264
Contact Persons: Diana L. Nader-Martone or Kathy Reddig Date Prepared: April 25, 2019
II. DEVICE NAME
| Device Name: | MicroLink™ All-Suture Button Fixation System
(Radiopaque) |
|----------------------|--------------------------------------------------------------------------------|
| Common Name: | Nonabsorbable Suture Fixation System |
| Classification Name: | Single/multiple component metallic bone fixation appliances
and accessories |
| Regulatory Class: | Class II, per 21 CFR Part 888. 3030 |
| Product Codes: | HTN |
III. PREDICATE/ LEGALLY MARKET DEVICE
| Device Name: | CMC Mini TightRope |
|---|---|
| Company Name: | Arthrex, Inc. |
| 510(k) #: | K140328 |
IV. DEVICE DESCRIPTION
The MicroLinkTM All-Suture Button Fixation System (Radiopaque) is an all-suture suspension device with one strand of #2 (5 metric) Hi-Fi® suture, a radiopaque flat braid Hi-Fi® Suture Button and a radiopaque flat braid Hi-Fi® suture Backstop threaded on a Loader. A suture passing drill is provided with a nitinol loop for passing. A trapezium pin is provided to facilitate manipulation of the trapezium during trapeziectomy. All four catalog numbers are provided sterile, intended for single-use.
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Image /page/4/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue abstract shape on the left, followed by the word "CONMED" in black, bold letters. Below "CONMED" is the word "CORPORATION" in smaller, blue letters.
INTENDED USE/ INDICATIONS FOR USE V.
The MicroLinkTM All-Suture Button Fixation System, when used for fixation of bone-tobone or soft-tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
The CONMED MicroLink All-Suture Button Fixation System is indicated for fixation of bone-to-bone as an adjunct in the following orthopedic surgical procedures:
| Procedure | Anatomic Location |
|---|---|
| Carpometacarpal Suspension | Hand |
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE
The following table represents a summary of the technological characteristics between the proposed and the predicate device.
| | MicroLink™ All-Suture Button Fixation System
(Radiopaque)
Proposed Device | CMC Mini TightRope
Predicate Device |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Device
Description | The MicroLink™ All-Suture Button Fixation
System (Radiopaque is an all-suture suspension
device with one strand of #2 (5 metric) Hi-Fi®
suture, a radio flat braid Hi-Fi® Suture Button
and a radiolucent flat braid Hi-Fi® suture
Backstop threaded on a Loader. A suture passing
drill is provided with a nitinol loop for passing.
A trapezium pin is provided to facilitate
manipulation of the trapezium during
trapeziectomy. All four catalog numbers are
provided sterile, intended for single-use. | |
| Intended Use | The MicroLink™ All-Suture Button Fixation
System, when used for fixation of bone-to-bone
or soft-tissue-to-bone, is intended as a fixation
post, distribution bridge, or for distributing suture
tension over areas of ligament or tendon repair. | |
| Indication for Use | The CONMED MicroLink All-Suture Button
Fixation System is indicated for fixation of
bone-to-bone as an adjunct in the following
orthopedic surgical procedures:
Procedure Anatomic Location
Carpometacarpal Suspension Hand | |
| Contraindications | 1. Pathological conditions of bone which
would adversely affect the device.
2. Physical conditions that would eliminate, or
tend to eliminate, adequate implant support
or retard healing.
3. Conditions which tend to limit the patient's
ability or willingness to restrict activities or
follow directions during the healing period. | |
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Image /page/5/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue graphic on the left, resembling a curved shape. To the right of the graphic, the word "CONMED" is displayed in a bold, sans-serif font, with a horizontal line underneath. Below the line, the word "CORPORATION" is written in a smaller, sans-serif font.
| | MicroLink™ All-Suture Button Fixation System
(Radiopaque)
Proposed Device | CMC Mini TightRope
Predicate Device |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 4. Attachment of artificial ligaments or other implants.
5. Foreign body sensitivity, known or suspected allergies to implant and/or instrument materials.
6. This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
7. Patients with active sepsis or infection.
8. | 6. Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
7. The use of this device may not be suitable for patients with insufficient or immature bone. The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature. The use of this medical device and the placement of hardware or implants must not bridge, disturb, or disrupt the growth plate.
8. Do not use for surgeries other than those indicated. |
| Components | All-Suture Button (Radiopaque) with suture
All-Suture Backstop
Loader
Trapezium Pin
Suture Passing Drill | TightRope Suture Construct with suture
Oblong Button for Mini TightRope
Loader
Trapeziectomy Tool w/ Handle
Suture Passing K-wire, short
Suture Passing K-wire, long
Suture Passing Wire, 8 inches |
| Technological
Characteristics | Flat-braid suture button
Flat-braid suture backstop
One #2 suture
Radiopaque implant
Suture Passing Drill to pull suture through one or more bones
Instrument to maneuver and remove bone | Stainless steel button
Stainless steel backstop
One #2 suture
Radiopaque implant
Suture passing drill to pull suture through one or more bones
Instrument to maneuver and remove bone |
VIII. PERFORMANCE DATA
Testing has been completed to demonstrate that the MicroLinkTM All-Suture Button Fixation System (Radiopaque) performs as intended and is substantially equivalent to the predicate device. Bacterial endotoxin testing was conducted and met the endotoxin limits.
Completed testing includes the following:
Verification Testing Sterilization
- . Reliability
- Pyrogen
●
IX.
-
Ultimate Fixation Strength
Side-by-Side Testing -
●
-
Biocompatibility
- Shelf-life
-
. Cyclic
-
User Validation ● Packaging ●
- Transportation ●
Validation Testing
- CONCLUSION
The MicroLink™ All-Suture Button Fixation System (Radiopaque) is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate CMC Mini TightRope. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the MicroLinkTM All-Suture Button Fixation System (Radiopaque) is substantially equivalent to the CMC Mini TightRope (K140328).