(116 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical technique, with no mention of AI/ML algorithms or data processing.
No
The device is a fixation system used during orthopedic surgery to provide stability and support to bones or soft tissues. It's not designed to treat a disease or condition itself, but rather to aid in the mechanical repair.
No
The device is a surgical fixation system used for bone-to-bone or soft-tissue-to-bone fixation, specifically for orthopaedic surgical procedures like carpometacarpal suspension. It is not used to identify or diagnose a condition.
No
The device description clearly outlines physical components such as sutures, 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-issue-to-bone" in orthopedic surgical procedures, specifically carpometacarpal suspension in the hand. This is a surgical implant/fixation device.
- Device Description: The description details a surgical implant system consisting of sutures, buttons, a loader, a drill, and a pin. These are all surgical tools and implants used directly on the patient's body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, the CONMED MicroLink™ All-Suture Button Fixation System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use
The CONMED MicroLinkTM All-Suture Button Fixation System, when used for fixation of bone-to-bone or soft-issue-to-bone, is intended as a fixation post, 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 Anatomic Location Carpometacarpal Suspension Hand
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The MicroLink™ All-Suture Button Fixation System (Radiolucent) is an all-suture suspension device with one strand of #2 (5 metric) Hi-Fi® suture, a radiolucent 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand (Carpometacarpal Suspension)
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 (Radiolucent) 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
Side-by-Side Testing -
Pyrogen ●
● -
Ultimate Fixation Strength ● ● Cyclic
● -
Biocompatibility Shelf-life ●
-
Shear Testing
Validation Testing
- User Validation ●
- 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
§ 888.3030 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CONMED Corporation Diana Nader-Martone Senior Regulatory Affairs Specialist 11311 Concept Boulevard Largo, Florida 33773
Re: K190516
Trade/Device Name: MicroLinkTM All-Suture Button Fixation System (Radiolucent) 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
1
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 of medical device-related adverse events) (21 CFR 803) for 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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
2
Indications for Use
510(k) Number (if known) K190516
Device Name MicroLink™M All-Suture Button Fixation System (Radiolucent)
Indications for Use (Describe)
Intended Use
The CONMED MicroLink™ All-Suture Button Fixation System, when used for fixation of bone-to-bone or soft-issue-tobone, is intended as a fixation post, 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 Anatomic Location Carpometacarpal Suspension Hand
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a stylized blue and white graphic on the left, resembling a wave or abstract shape. To the right of the graphic is the company name "CONMED" in a bold, sans-serif font, with a blue line underneath. Below the line, the word "CORPORATION" is printed in a smaller, sans-serif font.
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 _K190516
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: May 28, 2019
II. DEVICE NAME
| Device Name: | MicroLink™ All-Suture Button Fixation System
(Radiolucent) | |
|----------------------|--------------------------------------------------------------------------------|--|
| 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 MicroLink™ All-Suture Button Fixation System (Radiolucent) is an all-suture suspension device with one strand of #2 (5 metric) Hi-Fi® suture, a radiolucent 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.
4
Image /page/4/Picture/1 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white abstract shape inside on the left. To the right of the square is the word "CONMED" in black, with a horizontal line underneath. Below the line is the word "CORPORATION" in smaller, gray letters.
INTENDED USE/ INDICATIONS FOR USE V.
The CONMED 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.
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.
| MicroLinkTM All-Suture Button Fixation System | CMC Mini TightRope | |
|---|---|---|
| (Radiolucent) | Predicate Device | |
| Proposed Device | ||
| Device | The MicroLink™ All-Suture Button Fixation | |
| Description | System (Radiolucent) is an all-suture suspension | |
| device with one strand of #2 (5 metric) Hi-Fi® | ||
| suture, a radiolucent 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 CONMED MicroLink™ All-Suture Button | |
| Fixation System, when used for fixation of bone- | ||
| to-bone or soft-tissue-to-bone, is intended as a | Same | |
| 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 | Specifically, the Arthrex CMC Mini TightRope is |
| Fixation System is indicated for fixation of bone- | indicated for Carpal Metacarpal (CMC) joint | |
| to-bone as an adjunct in the following | arthroplasty as an adjunct in the suspension of the thumb | |
| orthopedic surgical procedures: | metacarpal during the healing process of hematoma | |
| Procedure | ||
| Anatomic Location | distraction arthroplasty by providing stabilization at the | |
| Carpometacarpal Suspension Hand | base of the first and second metacarpal when the | |
| trapezium has been excised due to osteoarthritis. | ||
| Contraindications | 1. | |
| Pathological conditions of bone which | Insufficient quantity or quality of bone. |
-
|
| | would adversely affect the device. | Blood supply limitations and previous infections,
2. |
| | 2.
Physical conditions that would eliminate, or | which may retard healing. |
| | tend to eliminate, adequate implant support | Foreign body sensitivity. Where material sensitivity
3. |
| | or retard healing. | is suspected, appropriate tests should be made and |
| | 3.
Conditions which tend to limit the patient's | sensitivity ruled out prior to implantation. |
| | ability or willingness to restrict activities or | Foreign Body Reactions. See Adverse Effects-
4. |
| | follow directions during the healing period. | Allergic Type Reactions. |
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Image /page/5/Picture/1 description: The image shows the logo for CONMED Corporation. The logo features a blue square with a white, stylized "C" shape inside. To the right of the square, the word "CONMED" is written in a bold, black sans-serif font. Below "CONMED", the word "CORPORATION" is written in a smaller, lighter font, with a blue line above it.
| | MicroLink™ All-Suture Button Fixation System
(Radiolucent)
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.
8. Patients with active sepsis or infection. | 5. Any active infection or blood supply limitations.
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 (Radiolucent) 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
Radiolucent implant
Suture Passing Drill to pull suture through one or
more bones
Instrument to maneuver and remove bone
MR Safe | 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 (Radiolucent) 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
Side-by-Side Testing -
Pyrogen ●
● -
Ultimate Fixation Strength ● ● Cyclic
● -
Biocompatibility Shelf-life ●
-
Shear Testing
Validation Testing
-
User Validation ●
-
Packaging
-
Transportation
-
IX. CONCLUSION
The MicroLink™ All-Suture Button Fixation System (Radiolucent) 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,
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Image /page/6/Picture/1 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue "C" shape on the left, followed by the word "CONMED" in bold, black letters. Below "CONMED" is the word "CORPORATION" in smaller, black letters.
and the MicroLink™ All-Suture Button Fixation System (Radiolucent) is substantially equivalent to the CMC Mini TightRope (K140328).