CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver

K171592 · Conmed Corporation · MAI · Aug 29, 2017 · Orthopedic

Device Facts

• Record ID: K171592
• Device Name: CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver
• Applicant: Conmed Corporation
• Product Code: MAI · Orthopedic
• Decision Date: Aug 29, 2017
• Decision: SESE
• Submission Type: Traditional
• 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 the following orthopedic surgical procedures: Procedure Joint Rotator Cuff Repair Shoulder Achilles Repair Ankle Bicep Tenodesis Shoulder Gluteus Medius Repair Hip Medial Patellofemoral Ligament (MPFL) Knee 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, 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

Sterile, single-use knotless suture anchor system; manufactured from polylactide copolymer (96L/4D PLA) and β-Tricalcium Phosphate (β-TCP). Preloaded on disposable driver. Used by orthopedic surgeons in arthroscopic or open procedures to reattach soft tissue (ligaments, tendons, joint capsules) to bone. Anchor provides mechanical fixation to stabilize damaged tissue during healing. System includes anchor, driver, suture/suture tape, and threader. Benefits include stabilization of soft tissue to bone to facilitate healing.

Clinical Evidence

Bench testing only. Verification testing included reliability, ultimate fixation strength, cyclic testing, sterilization, pyrogenicity, biocompatibility, and shelf-life. User validation included packaging and transportation. Clinical literature cited to support specific indications and anatomic locations.

Technological Characteristics

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

Indications for Use

Indicated for reattachment of soft tissue to bone in orthopedic surgical procedures including rotator cuff repair (shoulder), Achilles repair (ankle), bicep tenodesis (shoulder), gluteus medius repair (hip), and medial patellofemoral ligament (MPFL) repair (knee). Contraindicated in patients with pathological bone conditions, soft tissue pathology affecting fixation, physical conditions limiting implant support or healing, inability to follow postoperative restrictions, attachment of artificial ligaments, or known foreign body sensitivity/allergies to materials. Not for use in posterior elements (pedicles) of the spine.

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 (K170501)

Submission Summary (Full Text)

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August 29, 2017

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

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

Re: K171592

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: May 30, 2017 Received: May 31, 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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

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

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: January 31, 2017

See PRA Statement below.

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

### Indications for Use

510(k) Number (if known)

### K171592

Device Name

CrossFTM 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 the following orthopedic surgical procedures:

| Procedure | Joint |
|---------------------------------------|----------|
| Rotator Cuff Repair | Shoulder |
| Achilles Repair | Ankle |
| Bicep Tenodesis | Shoulder |
| Gluteus Medius Repair | Hip |
| Medial Patellofemoral Ligament (MPFL) | Knee |

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, 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)

> 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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### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

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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 the word "CORPORATION" in smaller blue letters underneath.

### 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 K171592

#### I. SUBMITTER

CONMED Corporation 525 French Road Utica, New York 13502

Phone: [phone] Fax: [phone]

Contact Person: Diana L. Nader-Martone Date Prepared: May 30, 2017

#### II. DEVICE NAME

| Device Name: | CrossFTTM Knotless Biocomposite Suture Anchor with |
|----------------------|----------------------------------------------------|
| | 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 DEVICE

| Device Name: | CrossFT™ Knotless Biocomposite Suture Anchor with |
|---------------|---------------------------------------------------|
| | Disposable Driver |
| Company Name: | ConMed Corporation |
| 510(k) #: | K170501 |

#### IV. DEVICE DESCRIPTION

The CrossFT™ Knotless Biocomposite Suture Anchors with Disposable Driver are sterile, single use devices. The CrossFTTM Knotless Biocomposite Suture Anchors with Disposable Driver are manufactured from polylactide copolymer (96L/4D PLA) and ß-Tricalcium Phosphate (8-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

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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 a bold, sans-serif font. Below the word "CONMED" is the word "CORPORATION" in a smaller, sans-serif font. A blue line underlines the word "CONMED".

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

| Procedure | Joint |
|---------------------------------------|----------|
| Rotator cuff repair | Shoulder |
| Achilles Repair | Ankle |
| Bicep Tenodesis | Shoulder |
| Gluteus Medius Repair | Hip |
| Medial Patellofemoral Ligament (MPFL) | Knee |

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 | CrossFTTM Knotless Biocomposite Suture<br>Anchor with Disposable Driver<br>Predicate | | | | | | | | | | | | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | Same | 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 are 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. | | | | | | | | | | | | |
| Intended Use | The CrossFTTM Knotless Biocomposite Suture<br>Anchor with Disposable Driver is intended to<br>reattach soft tissue to bone in the following<br>orthopedic surgical procedures:<br>Procedure Joint Rotator Cuff Repair Shoulder Achilles Repair Ankle Bicep Tenodesis Shoulder Gluteus Medius Repair Hip Medial Patellofemoral Ligament (MPFL) Knee | | | | | | | | | | | | | The CrossFTTM Knotless Biocomposite Suture<br>Anchor with Disposable Driver is intended to<br>reattach soft tissue to bone in orthopedic surgical<br>procedures. |
| Indication for Use | Same | 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. | | | | | | | | | | | | |

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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 bold, black letters. Below the word "CONMED" is the word "CORPORATION" in smaller, black letters. A thin blue line separates the two words.

| | CrossFT™ Knotless Biocomposite Suture<br>Anchor with Disposable Driver<br>Proposed | CrossFT™ Knotless Biocomposite Suture<br>Anchor with Disposable Driver<br>Predicate |
|-------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contraindications | Same | *Pathological conditions of bone which would<br>adversely affect the CrossFT™ 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.<br>* 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 | Same | Bioabsorbable anchor<br>Disposable Driver<br>Suture and/or Suture Tape<br>Threader |

## VII. PERFORMANCE DATA

Testing has been completed to demonstrate that the CrossFT™ Knotless Biocomposite Suture Anchor 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. The test parameters utilized were supported by clinical data in the literature to support the specific indications and corresponding anatomic locations in this submission.

Completed testing includes the following:

Verification Testing

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

● User Validation

- Packaging .
- Transportation ●

Validation Testing

- VIII. CONCLUSION
The CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver is identical in design, materials, principles of operation, and technical characteristics to the predicate, and substantially equivalent in intended use to the predicate. Based upon the findings of our performance testing, the difference regarding intended use presents no new issues of

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Image /page/6/Picture/0 description: The image shows the logo for Conmed Corporation. The logo consists of 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 the word "CORPORATION" in smaller blue letters underneath.

safety and efficacy, and the proposed, CrossFT™ Knotless Biocomposite Suture Anchor
with Disposable Driver is substantially equivalent to the CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver (K170501).