CuffLink Implant System Biocomposite

K180763 · Conmed Corporation · MAI · Jul 19, 2018 · Orthopedic

Device Facts

• Record ID: K180763
• Device Name: CuffLink Implant System Biocomposite
• Applicant: Conmed Corporation
• Product Code: MAI · Orthopedic
• Decision Date: Jul 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Implant 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.

Device Story

The CuffLink Implant System Biocomposite is a sterile, single-use kit for orthopedic soft tissue-to-bone fixation. It contains four suture anchors (a combination of CrossFT Knotless Biocomposite and Y-Knot RC All-Suture anchors), a disposable broaching punch, and a suture passing loop. Used in arthroscopic or open surgical procedures, the device is operated by orthopedic surgeons. The surgeon anchors the suture into the bone to stabilize damaged soft tissue (ligaments, tendons, or joint capsules) during the healing period, supported by postoperative immobilization. The system provides a mechanical means for tissue reattachment, facilitating healing by maintaining tissue position against the bone.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1), packaging, user validation, shelf life, sterilization, transportation, and pyrogenicity/bacterial endotoxin limits.

Technological Characteristics

Materials: UHMWPE, polyester, nylon suture, stainless steel, polycarbonate, 96L/4D co-polymer, and β-TCP. Form factor: Kit containing four suture anchors, disposable broaching punch, and suture passing loop in a PETG tray. Single-use, sterile. Mechanical fixation principle.

Indications for Use

Indicated for reattachment of soft tissue to bone in rotator cuff repair (shoulder) and Achilles repair (ankle).

Regulatory Classification

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.

Predicate Devices

• CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver (K171592)

Reference Devices

• CuffLink Implant System (K171725)
• Y-Knot RC All-Suture Anchor (K133224)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CONMED Corporation Diana L. Nader-Martone Regulatory Affairs Specialist 525 French Road Utica, New York 13502

July 19, 2018

Re: K180763

Trade/Device Name: CuffLink Implant System Biocomposite Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: June 15, 2018 Received: June 18, 2018

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. 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 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020 See PRA Statement below.

## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

1

510(k) Number (if known)

K180763

Device Name CuffLink Implant System Biocomposite

Indications for Use (Describe)

### INTENDED USE

The Implant 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.

### INDICATIONS FOR USE

The CuffLinkTM Implant System Biocomposite is indicated to reattach soft tissue to bone in the following orthopedic surgical procedures.

| Procedure | Joint |
|---------------------|----------|
| Rotator cuff repair | Shoulder |
| Achilles Repair | Ankle |

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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue and white graphic on the left, followed by the word "CONMED" in black, bold letters. Below "CONMED" is the word "CORPORATION" in smaller, lighter letters, also in black.

## 510(k) SUMMARY

- l. SUBMITTER
CONMED Corporation 525 French Road Utica, NY 13502

| Phone: | 727.399.5425 |
|--------|--------------|
| Fax: | 727.399.5264 |

Diana L. Nader-Martone Contact Person: Date Prepared: June 15, 2018

- II. DEVICE

| Device Name: | CuffLinkTM Implant System Biocomposite |
|-------------------------|------------------------------------------------|
| Trade Name/Common Name: | Bioabsorbable Suture Anchor |
| Classification Name: | Fastener, fixation, biodegradable, soft tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888.3030 |
| Product Code: | MAI, MBI |

#### III. PREDICATE DEVICE

CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver Device Name: Manufacturer: CONMED Corporation 510(k) Number: K171592

- IV. REFERENCE DEVICE

| Device Name: | CuffLink™ Implant System |
|----------------|--------------------------|
| Manufacturer: | CONMED Corporation |
| 510(k) Number: | K171725 |

#### V. DEVICE DESCRIPTION

The CuffLink™ Implant System Biocomposite consists of six kits that are provided sterile, for single-use only. Each kit contains four (4) suture anchors in various combinations of the CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver (K171592) and Y-Knot RC All-Suture Anchor (K133224). Two (2) of the anchors are meant to be used as the primary/medial row and two (2) anchors are meant to be used for the knotless/lateral row. Each kit also contains one (1) disposable broaching punch, and one (1) suture passing loop assembled in a single PETG tray, and sealed in a Tyvek pouch.

- VI. INTENDED USE/INDICATIONS FOR USE STATEMENT
## INTENDED USE

The Implant 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

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Image /page/4/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of a blue abstract shape on the left, followed by the word "CONMED" in black, bold letters. Below the word "CONMED" is the word "CORPORATION" in smaller, gray letters. There is a blue line separating the two words.

damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

## INDICATIONS FOR USE

The CuffLink™ Implant System Biocomposite is indicated to reattach soft tissue to bone in the following orthopedic surgical procedures.

| Procedure | Joint |
|---------------------|----------|
| Rotator Cuff Repair | Shoulder |
| Achilles Repair | Ankle |

- VII. COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
CONMED's CuffLink Implant System Biocomposite is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the CONMED CrossFT Knotless Biocomposite Suture Anchor (predicate device (K171592)) with Disposable Driver and CuffLink™ Implant System (reference device (K171725)) and raises no new issues of safety or effectiveness.

The similarities and differences between the proposed, predicate, and reference devices are summarized in the table below.

| | Proposed Device | Predicate Device | Reference Device |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | CuffLink™ Implant System<br>Biocomposite | CrossFT™ Knotless<br>Biocomposite Suture<br>Anchor with Disposable<br>Driver | CuffLink™ Implant<br>System |
| 510(k) Number | | K171592 | K171725 |
| Manufacturer | CONMED Corporation | | |
| Intended Use | The Implant System may<br>be used in either<br>arthroscopic or open<br>surgical procedures. After<br>the suture is anchored to<br>the bone, it may be used<br>to reattach soft tissue,<br>such as ligaments,<br>tendons, or joint capsules<br>to the bone. The suture<br>anchor system thereby<br>stabilizes the damaged<br>soft tissue, in conjunction<br>with appropriate<br>postoperative<br>immobilization, | The biocomposite suture<br>anchor is intended to<br>reattach soft tissue to bone<br>in the following orthopedic<br>surgical procedures:<br><br>Procedure Joint<br>Rotator cuff repair Shoulder<br>Achilles Repair Ankle<br>Biceps Tenodesis Shoulder<br>Gluteus Medius Repair Hip<br>Medial Patellofemoral Knee<br>Ligament (MPFL) | The CuffLink™ Implant<br>System is intended to<br>reattach soft tissue to<br>bone in orthopedic<br>surgical procedures. |
| | throughout the healing<br>period. | | |
| Indications for Use | The CuffLink™ Implant<br>System Biocomposite is<br>indicated to reattach soft<br>tissue to bone in the<br>following orthopedic<br>surgical procedures.<br>Procedure<br>Joint<br>Rotator Cuff Repair Shoulder<br>Achilles Repair Ankle | The device may be used in<br>either arthroscopic or open<br>surgical procedures. After<br>the suture is anchored to<br>the bone, it may be used to<br>reattach soft tissue, such as<br>ligaments, tendons, or joint<br>capsules to the bone. The<br>suture anchor system<br>thereby stabilizes the<br>damaged soft tissue, in<br>conjunction with appropriate<br>postoperative<br>immobilization, throughout<br>the healing period. | The Implant System may<br>be used in either<br>arthroscopic or open<br>surgical procedures. After<br>the suture is anchored to<br>the bone, it may be used<br>to reattach soft tissue,<br>such as ligaments,<br>tendons, or joint capsules<br>to the bone. The suture<br>anchor system thereby<br>stabilizes the damaged<br>soft tissue, in conjunction<br>with appropriate<br>postoperative<br>immobilization,<br>throughout the healing<br>period. |
| | Proposed Device | Predicate Device | Reference Device |
| Device | CuffLink™ Implant System<br>Biocomposite | CrossFT™ Knotless<br>Biocomposite Suture<br>Anchor with Disposable<br>Driver | CuffLink™ Implant<br>System |
| Contraindications | 1. Pathological conditions<br>of bone which would<br>adversely affect the<br>CuffLink™ Implant<br>System Biocomposite.<br>2. Pathological conditions<br>in the soft tissue to be<br>repaired or reconstructed<br>which would adversely<br>affect suture fixation.<br>3. Physical conditions<br>that would eliminate, or<br>tend to eliminate,<br>adequate implant support<br>or retard healing. | 1. Pathological conditions<br>of bone which would<br>adversely affect the<br>CrossFT™ Knotless<br>Biocomposite Suture<br>Anchor.<br>2. Pathological conditions<br>in the soft tissue to be<br>repaired or reconstructed<br>which would adversely<br>affect suture fixation.<br>3. Physical conditions that<br>would eliminate, or tend to<br>eliminate, adequate<br>implant support or retard<br>healing. | 1. Pathological<br>conditions of bone which<br>would adversely affect<br>the CuffLink™ Implant<br>System.<br>2. Pathological<br>conditions in the soft<br>tissue to be repaired or<br>reconstructed which<br>would adversely affect<br>suture fixation.<br>3. Physical conditions<br>that would eliminate, or<br>tend to eliminate,<br>adequate implant<br>support or retard<br>healing. |
| | 4. Conditions which tend<br>to limit the patient's<br>ability or willingness to<br>restrict activities or follow<br>directions during the | 4. Conditions which tend<br>to limit the patient's ability<br>or willingness to restrict<br>activities or follow | 4. Conditions which tend<br>to limit the patient's<br>ability or willingness to |
| | healing period. | directions during the | restrict activities or follow |
| | 5. Attachment of artificial | healing period. | directions during the<br>healing period. |
| | ligaments or other<br>implants.<br>6. Foreign body | 5. Attachment of artificial<br>ligaments or other<br>implants. | 5. Attachment of artificial<br>ligaments or other<br>implants. |
| | sensitivity, known or<br>suspected allergies to<br>implant and/or instrument<br>materials. | 6. Foreign body sensitivity,<br>known or suspected<br>allergies to implant and/or<br>instrument materials. | 6. Foreign body<br>sensitivity, known or<br>suspected allergies to<br>implant and/or |
| | 7. This device is not<br>approved for screw | 7. This device is not<br>approved for screw | instrument materials. |
| | attachment or fixation to<br>the posterior elements<br>(pedicles) of the cervical,<br>thoracic or lumbar spine. | attachment or fixation to<br>the posterior elements<br>(pedicles) of the cervical,<br>thoracic or lumbar spine. | 7. This device is not<br>approved for screw<br>attachment or fixation to<br>the posterior elements<br>(pedicles) of the cervical,<br>thoracic or lumbar spine. |
| | Proposed Device | Predicate Device | Reference Device |
| Device | CuffLink™ Implant System<br>Biocomposite | CrossFT™ Knotless<br>Biocomposite Suture<br>Anchor with Disposable<br>Driver | CuffLink™ Implant<br>System |
| Reuse/Sterilization | Single-Use | | |
| Principle of<br>Operation | Soft tissue to bone fixation | | |
| Biocompatibility | In accordance with ISO 10993-1 and FDA # G95-1 | | |
| Packaging | Multiple implants in tray | Single device unit in<br>package | Multiple implants in tray |
| Materials | UHMWPE, polyester, nylon suture, stainless steel,<br>polycarbonate, 96L/4D co-polymer and β-TCP | | UHMWPE, polyester,<br>nylon suture, stainless<br>steel, polycarbonate,<br>PEEK Optima® |

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Image /page/5/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, with a horizontal line underneath. Below the line, the word "CORPORATION" is written in smaller, black letters.

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Image /page/6/Picture/0 description: The image shows the logo for Conmed Corporation. The logo features a blue square with a white "C" shape inside on the left. To the right of the square is the word "CONMED" in a bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font.

### PERFORMANCE DATA VIII.

Testing has been completed to demonstrate that the Cufflink™ Implant System Biocomposite performs as intended and is substantially equivalent to the predicate device. The bacterial endotoxin testing was conducted and met the endotoxin limits.

Completed testing includes biocompatibility, packaging, user validation, shelf life, sterilization, transportation, and pyrogenicity.

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Image /page/7/Picture/0 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, sans-serif font. Below the word "CONMED", the word "CORPORATION" is written in a smaller, sans-serif font.

### CONCLUSION IX.

CONMED's Cufflink™ Implant System Biocomposite is either substantially equivalent or identical in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the predicate and reference devices. Based upon the findings of performance testing, the differences do not present any novel issues of safety and efficacy, and is substantially equivalent to the predicate device.