Argo Knotless SP Anchor

K220757 · Conmed Corporation · MBI · May 13, 2022 · Orthopedic

Device Facts

• Record ID: K220757
• Device Name: Argo Knotless SP Anchor
• Applicant: Conmed Corporation
• Product Code: MBI · Orthopedic
• Decision Date: May 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless™ SP Anchor 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 tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

Device Story

Argo Knotless™ SP Anchor is a soft tissue-to-bone fixation device; consists of titanium tip with eyelet and PEEK threaded anchor body; includes 1.0mm UHMWPE Hi-Fi™ retention ribbon. Used in arthroscopic or open orthopedic surgeries; operated by surgeons. Device stabilizes damaged tissue by anchoring suture to bone; requires postoperative immobilization. Benefits patient by securing soft tissue to bone to facilitate healing.

Clinical Evidence

Bench testing only. Performance testing included reliability, ultimate fixation strength, insertion torque, cyclic testing, and user validation. Biocompatibility testing performed per ISO 10993-1 and FDA G95-1. Bacterial endotoxin testing met established limits.

Technological Characteristics

Anchor: Titanium tip, PEEK body. Suture: UHMWPE with polyester. Driver: Stainless steel, polycarbonate, ABS, Radel. Threader: ABS, nitinol, stainless steel. Sterilization: Ethylene Oxide (SAL 10^-6). MR Conditional. Single-use. Shelf-life: 18 months.

Indications for Use

Indicated for reattachment of soft tissue (ligaments, tendons, joint capsules) to bone in orthopedic surgical procedures. Contraindicated in patients with bone/soft tissue pathology affecting fixation, physical conditions retarding healing, inability to restrict activities, foreign body sensitivity, or for spinal pedicle fixation.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• CrossFT Knotless Suture Anchor (K163258)

Submission Summary (Full Text)

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May 13, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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 Dionne Sanders, MS, CQA, RAC Senior Manager, Regulatory Affairs 525 French Road Utica, New York 13502

Re: K220757

Trade/Device Name: Argo Knotless™ SP Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: March 10, 2022 Received: March 15, 2022

Dear Dionne Sanders:

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 of medical device-related adverse events) (21 CFR 803) for

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For:

Laura C. Rose, 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) K220757

Device Name Argo Knotless™ SP Anchor

### Indications for Use (Describe)

The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.

The Argo Knotless™ SP Anchor 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 tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 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 K220757.

#### I. SUBMITTER

Manufacturer: CONMED Corporation 525 French Road Utica, NY 13502

Official Contact Person: Dionne Sanders, MS, CQA, RAC 525 French Road Utica, NY 13502 (O) 813-997-8126

Date Prepared: May 13, 2022

#### II. DEVICE NAME

| Device Name: | Argo Knotless™ SP Anchor |
|----------------------|----------------------------------------------------|
| Classification Name: | Smooth Or Threaded Metallic Bone Fixation Fastener |
| Regulatory Class: | Class II, per 21 CFR Part 888.3040 |
| Product Codes: | MBI |

#### III. PREDICATE/ LEGALLY MARKETED DEVICE

| Device Name: | CrossFT Knotless Suture Anchor |
|---------------|--------------------------------|
| Company Name: | CONMED Corporation |
| 510(k) #: | K163258 |

#### IV. DEVICE DESCRIPTION

The Argo Knotless™ SP Anchor is a soft tissue to bone fixation device that consists of a titanium tip with an eyelet to thread suture through, and a threaded anchor body, manufactured of PEEK material. The anchor design includes a 1.0mm UHMWPE Hi-Fi™ retention ribbon which secures the titanium tip to the delivery system and to the retention suture cleat.

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

The non-absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.

The Argo Knotless™ SP Anchor 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

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stabilizes the damaged 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.

| | Proposed Device | Predicate Device |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | CONMED | CONMED |
| Device Name | Argo KnotlessTM SP Anchor | CrossFT Knotless Suture Anchor |
| 510k Number | TBD | K163258 |
| Intended<br>Use/Indications<br>for Use | The non-absorbable suture<br>anchor is intended to reattach<br>soft tissue to bone in<br>orthopedic surgical procedures.<br><br>The Argo KnotlessTM SP<br>Anchor may be used in either<br>arthroscopic or open surgical<br>procedures. After the suture is<br>anchored to the bone, it may be<br>used to reattach soft tissue,<br>such as ligaments, tendons, or<br>joint capsules to the bone. The<br>suture anchor system thereby<br>stabilizes the damaged tissue,<br>in conjunction with<br>appropriate postoperative<br>immobilization throughout the<br>healing period. | The CrossFT Knotless Suture Anchor<br>with Disposable Driver is intended to<br>reattach soft tissue to bone in<br>orthopedic surgical procedures.<br><br>The device may be used in either<br>arthroscopic or open procedures.<br>After the suture is anchored to the<br>bone, it may be used to reattach soft<br>tissue, such as ligaments, tendons, or<br>joint capsules to the bone. The suture<br>anchor system thereby stabilizes the<br>damaged soft tissue, in conjunction<br>with appropriate postoperative<br>immobilization, throughout the<br>healing period. |
| Contraindications | 1. Pathological conditions of<br>bone which would adversely<br>affect the Argo KnotlessTM SP<br>anchors.<br>2. Pathological conditions in<br>the soft tissue to be repaired or<br>reconstructed which would<br>adversely affect suture<br>fixation.<br>3. Physical conditions that<br>would eliminate, or tend to<br>eliminate, adequate implant<br>support or retard healing.<br>4. Conditions which tend to<br>limit the patient's ability or | 1. Pathological conditions of bone<br>which would adversely affect the<br>CrossFT Knotless Suture Anchor.<br>2. Pathological conditions in the soft<br>tissue to be repaired or<br>reconstructed which would<br>adversely affect suture fixation.<br>3. Physical conditions that would<br>eliminate, or tend to eliminate,<br>adequate implant support or retard<br>healing.<br>4. Conditions which tend to limit the<br>patient's ability or willingness to<br>restrict activities or follow |
| | willingness to restrict activities<br>or follow directions during the<br>healing period.<br>5. Attachment of artificial<br>ligaments or other implants.<br>6. Foreign body sensitivity,<br>known or suspected allergies<br>to implant and/or instrument<br>materials.<br>7. This device is not approved<br>for screw attachment or<br>fixation to the posterior<br>elements (pedicles) of the<br>cervical, thoracic or lumbar<br>spine. | directions during the healing<br>period.<br>5. Attachment of artificial ligaments<br>or other implants.<br>6. Foreign body sensitivity, known or<br>suspected allergies to implant<br>and/or instrument materials.<br>7. This device is not approved for<br>screw attachment or fixation to the<br>posterior elements (pedicles) of the<br>cervical, thoracic or lumbar spine. |
| How Supplied | Sterile Anchor w/Delivery System (1ea) | |
| Single Use<br>/Reusable | Single-Use Only | |
| Sterilization | Device sterilized via Ethylene Oxide Sterilization - SAL (10-6) | |
| Shelf-Life | 18-months | |
| Principle of<br>Operation | Non-absorbable suture anchors for soft tissue to bone fixation | |
| Biocompatibility | In accordance with ISO 10993-1 and FDA# G95-1 | |
| Packaging | Packaged as a single unit device | |
| Instrumentation | Reusable Bone Punch<br>Sterile Disposable Bone Punch<br>Drill Bit | |
| Suture | White UHMWPE, with<br>polyester dyed with D&C Blue<br>#6 | Black suture, Nylon with<br>logwood extract Blue suture, polyester per with<br>D&C Blue #6, silicone coating Blue Suture, UHMWPE, dyed<br>with D&C Blue #6 |
| Materials | Anchor: Titanium Tip; PEEK<br>Suture: White, UHMWPE<br>with polyester dyed with D&C<br>Blue #6<br>Driver: Stainless Steel<br>Driver Handle: Polycarbonate,<br>ABS, Radel<br>Threader: ABS, nitinol,<br>stainless steel | Anchor: PEEK<br>Suture: UHMWPE, Nylon, polyester<br>Driver Shaft and Tip: 17-7 Stainless<br>Steel; 465 Stainless Steel<br>Handle and Knob: Polycarbonate<br>Threader: Polycarbonate, Nitinol |
| MR<br>Compatibility | MR Conditional | MR Safe |
| Performance<br>Testing | Reliability | |
| | Cyclic Loading | |
| | Insertion | |
| | Fixation | |

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#### VII. PERFORMANCE DATA

Testing has been completed to demonstrate that the Argo Knotless™ SP Anchor 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:

Performance Testing Reliability Ultimate Fixation Strength Insertion Torque Cyclic Testing

Validation User Validation Packaging and Transportation Labeling Sterilization

Well-established Method Testing Pyrogen (Bacterial Endotoxin) Biocompatibility Shelf-life MR Safety Testing

#### VIII. CONCLUSION

The Argo Knotless™ SP Anchor is either substantially equivalent or identical in intended use, principles of operation, performance testing results, packaging, sterilization method, and biocompatibility as the predicate CrossFT Knotless Suture Anchors. Based upon the findings of our performance testing, the differences present no new issues of safety and effectiveness, and the Argo Knotless™ SP Anchors are substantially equivalent to the predicate device, CrossFT Knotless Suture Anchors (K163248).