CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver

K170501 · Conmed Corporation · MAI · Mar 17, 2017 · Orthopedic

Device Facts

• Record ID: K170501
• Device Name: CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver
• Applicant: Conmed Corporation
• Product Code: MAI · Orthopedic
• Decision Date: Mar 17, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device 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 CrossFT™ Knotless Biocomposite Suture Anchor is a sterile, single-use orthopedic implant designed to reattach soft tissue to bone. The system consists of a bioabsorbable anchor, a disposable driver, suture/suture tape, and a threader. During orthopedic surgery (arthroscopic or open), the surgeon uses the disposable driver to implant the anchor into the bone. Once anchored, the suture is used to secure ligaments, tendons, or joint capsules. The device stabilizes damaged soft tissue during the healing process, after which the anchor is intended to be absorbed. The device is operated by orthopedic surgeons in clinical settings. It provides mechanical fixation to facilitate tissue-to-bone healing, reducing the need for traditional knot-tying techniques.

Clinical Evidence

Bench testing only. Performance data includes verification testing for reliability, ultimate fixation strength, cyclic testing, sterilization, pyrogenicity, biocompatibility, and shelf-life. Validation testing included user validation, packaging, and transportation. Bacterial endotoxin testing met established limits.

Technological Characteristics

Materials: Polylactide copolymer (96L/4D PLA) and β-Tricalcium Phosphate (β-TCP). Form factor: Suture anchor preloaded on a disposable driver. Available in three sizes and nine configurations. Sterilization: Provided sterile, single-use. Mechanical fixation principle.

Indications for Use

Indicated for reattachment of soft tissue (ligaments, tendons, joint capsules) to bone in orthopedic surgical procedures, including arthroscopic or open approaches. Contraindicated in patients with pathological bone or soft tissue conditions affecting fixation, conditions limiting activity restriction/compliance, attachment of artificial ligaments, or known foreign body sensitivity/allergies to implant materials. Not approved for posterior spinal element fixation.

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

• ConMed Linvtec CrossFT™ BC Suture Anchor (K101100)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right, with a symbol resembling a caduceus or staff with a serpent intertwined.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 17, 2017

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

Re: K170501

Trade/Device Name: CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: February 17, 2017 Received: February 21, 2017

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Lori A. Wiggins -S

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

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| <b>Indications for Use</b> | |
| Form Approved: | OMB No. 0910-0120 |
| Expiration Date: | January 31, 2017 |
| | See PRA Statement below. |
| 510(k) Number (if known) | K170501 |
| Device Name | CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver |
| Indications for Use (Describe) | The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures. The device 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. |
| Type of Use (Select one or both, as applicable) | |
| | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
| 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 "C" shape on the left, followed by the word "CONMED" in black, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, underlined with a blue line.

### 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

#### I. SUBMITTER

CONMED Corporation 11311 Concept Blvd Largo, Florida 33773

Phone: [phone] Fax: [phone]

Contact Person: Diana L. Nader-Martone Date Prepared: February 17, 2017

#### II. DEVICE NAME

| Device Name: | CrossFT™ Knotless Biocomposite Suture Anchor with<br>Disposable Driver |
|----------------------|------------------------------------------------------------------------|
| Common Name: | Bioabsorbable Suture Anchor |
| Classification Name: | Fastener, fixation, biodegradable, soft tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888. 3030 |
| Product Codes: | MAI |

#### III. PREDICATE/ LEGALLY MARKET DEVICE

| Device Name: | ConMed Linvtec CrossFT™ BC Suture Anchor |
|---------------|------------------------------------------|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K101100 |

#### IV. DEVICE DESCRIPTION

The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are manufactured from polylactide copolymer (96L/4D PLA) and ß-Tricalcium Phosphate (ß-TCP). The anchors are provided sterile, single use and preloaded on a disposable driver. The anchors are available in three sizes and nine configurations.

#### V. INTENDED USE/ INDICATIONS FOR USE

The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is intended to reattach soft tissue to bone in orthopedic surgical procedures.

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Image /page/4/Picture/0 description: The image shows the logo for CONMED Corporation. The logo features a stylized blue "C" shape on the left side. To the right of the "C" is the word "CONMED" in a bold, sans-serif font, with a blue line underneath. Below the line is the word "CORPORATION" in a smaller, sans-serif font.

The device 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.

### COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The following table represents a summary of the technological characteristics between the proposed and the predicate device.

| | CrossFTTM Knotless Biocomposite Suture<br>Anchor with Disposable Driver<br>Proposed | ConMed Linvatec CrossFTTM-BC Suture Anchor<br>(also known as: GENESYSTM CrossFTTM Suture<br>Anchor)<br>Predicate |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | The CrossFTTM Knotless Biocomposite Suture<br>Anchor with Disposable Drivers are sterile, single<br>use devices. The CrossFTTM Knotless<br>Biocomposite Suture Anchor with Disposable<br>Drivers is manufactured from polylactide<br>copolymer (96L/4D PLA) and β-Tricalcium<br>Phosphate (β-TCP). The anchors are provided<br>sterile, single use and preloaded on a disposable<br>driver. The anchors are available in three sizes<br>and nine configurations. | The ConMed Linvatec CrossFTTM-BC Suture<br>Anchor is a device that is used to assist the<br>surgeon in reattaching soft tissue to bone. The<br>device includes anchors, manufactured of 96L/4D<br>PLA copolymer + β-TCP and two (2), or three (3)<br>Hi-Fi® sutures manufactured of polyethylene and<br>polypropylene. The device is bioabsorbable and<br>is available in sizes between 4.5mm to 6.5mm<br>and 17mm lengths. A disposable driver is<br>included to implant the suture anchor. |
| Intended Use | The CrossFTTM Knotless Biocomposite Suture<br>Anchor with Disposable Driver with Disposable<br>Driver is intended to reattach soft tissue to bone<br>in orthopedic surgical procedures. | The CrossFTTM-BC Suture Anchor is intended to<br>reattach soft tissue to bone in orthopedic surgical<br>procedures. |
| Indication for Use | The device may be used in either arthroscopic or<br>open surgical procedures. After the suture is<br>anchored to the bone, it may be used to reattach<br>soft tissue, such as ligaments, tendons, or joint<br>capsules to the bone. The suture anchor system<br>thereby stabilizes the damaged soft tissue, in<br>conjunction with appropriate postoperative<br>immobilization, throughout the healing period. | The device may be used in either arthroscopic or<br>open surgical procedures. After the suture is<br>anchored to the bone, it may be used to reattach<br>soft tissue, such as ligaments, tendons, or joint<br>capsules to the bone. The suture anchor system<br>thereby stabilizes the damaged soft tissue, in<br>conjunction with appropriate postoperative<br>immobilization, throughout the healing period. |
| Contraindications | *Pathological conditions of bone which would<br>adversely affect the CrossFTTM Knotless<br>Biocomposite Suture Anchor with Disposable<br>Driver with Disposable Driver.<br>* Pathological conditions in the soft tissue to be<br>repaired or reconstructed which would adversely<br>affect suture fixation.<br>* Physical conditions that would eliminate, or<br>tend to eliminate, adequate implant support or<br>retard healing.<br>* Conditions which tend to limit the patient's<br>ability or willingness to restrict activities or<br>follow directions during the healing period.<br>* Attachment of artificial ligaments or other<br>implants.<br>* Foreign body sensitivity, known or suspected<br>allergies to implant and/ or instrument materials | The CrossFTTM BC Suture Anchor is<br>contraindicated for the following orthopedic<br>procedures:<br>- ACL (Anterior Cruciate Ligament), PCL<br>(Posterior Cruciate Ligament), foot, and hand<br>procedures |

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Image /page/5/Picture/0 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 black, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font, underlined by a thin blue line.

| | CrossFT™ Knotless Biocomposite Suture<br>Anchor with Disposable Driver<br>Proposed | ConMed Linvatec CrossFT™-BC Suture Anchor<br>(also known as: GENESYS™ CrossFT™ Suture<br>Anchor)<br>Predicate |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| | * This device is not approved for screw<br>attachment or fixation to the posterior elements<br>(pedicles) of the cervical, thoracic or lumbar<br>spine. | |
| Components | Bioabsorbable anchor<br>Disposable Driver<br>Suture and/or Suture Tape<br>Threader | Bioabsorbable anchor<br>Disposable driver<br>Suture |

## PERFORMANCE DATA

Testing has been completed to demonstrate that the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver with Disposable Driver 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 the following:

Verification Testing

- Reliability
- Ultimate Fixation Strength ●
- Cyclic
- Sterilization ●
- Pyrogenicity ●
- Biocompatibility ●
- Shelf-life ●

### VIII. CONCLUSION

The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver with Disposable Driver is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate CrossFTTM BC Suture Anchor. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver with Disposable Driver is substantially equivalent to the CrossFTTM-BC Suture Anchor (K101100).

Validation Testing

- User Validation
- Packaging ●
- Transportation ●