Y-Knot OneStep Anchor

K193606 · Conmed Corporation · MBI · Jan 22, 2020 · Orthopedic

Device Facts

• Record ID: K193606
• Device Name: Y-Knot OneStep Anchor
• Applicant: Conmed Corporation
• Product Code: MBI · Orthopedic
• Decision Date: Jan 22, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The non-absorbable implant is intended to reattach soft tissue to bone in orthopedic surgical procedures. The devices may be used in either arthroscopic or open surgical procedures. After suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate immobilizations, throughout the healing period.

Device Story

Y-Knot® OneStep™ Anchor is a non-absorbable, all-suture orthopedic implant designed to reattach soft tissue to bone. The device consists of a high-strength flat-braided suture anchor preloaded onto a disposable, flexible inserter. During surgery, the clinician uses the inserter to drill a pilot hole and perform a press-fit insertion of the anchor into the bone. Once deployed, the anchor expands to secure the suture, which is then used to reattach ligaments, tendons, or joint capsules. The system is intended for use in both arthroscopic and open surgical procedures. By stabilizing damaged soft tissue during the healing period, the device facilitates tissue-to-bone repair. It is provided sterile for single-use.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included reliability, fixation/pull-out strength, displacement, cyclic loading, sterilization, pyrogenicity, biocompatibility (ISO 10993-1), shelf-life, transportation, post-aging functional testing, and MR safety. Validation included user validation and packaging/labeling assessment. Bacterial endotoxin testing met established limits.

Technological Characteristics

All-suture anchor system; high-strength flat-braided suture; one or two #2 Hi-Fi® suture strands or ribbon. Features expandable design for press-fit fixation. Flexible disposable inserter. Sterilized via Ethylene Oxide (EtO) to SAL 10^-6. Biocompatible materials per ISO 10993-1. Single-use.

Indications for Use

Indicated for reattachment of soft tissue (ligaments, tendons, joint capsules) to bone in orthopedic surgical procedures (arthroscopic or open). Contraindications: pathological bone/soft tissue conditions, physical conditions preventing implant support/healing, inability to follow post-op restrictions, attachment of artificial ligaments/implants, foreign body sensitivity/allergies, cervical/thoracic/lumbar pedicle fixation, active sepsis/infection.

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

• Y-Knot® Flex All-Suture Anchor (K131035)

Submission Summary (Full Text)

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January 22, 2020

ConMed Corporation Carrie Engleman Lead Regulatory Affairs Specialist 525 French Road Utica, New York 13502

Re: K193606

Trade/Device Name: Y-Knot® OneStep™ Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 20, 2019 Received: December 23, 2019

Dear Ms. Engleman:

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

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

Sincerely,

Laura C. Rose, Ph.D. Acting 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)

## K193606

Device Name Y-Knot® OneStep™ Anchor

Indications for Use (Describe)

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

The devices may be used in either arthroscopic or open surgical procedures. After suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate immobilizations, 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)

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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

#### I. SUBMITTER

CONMED Corporation 525 French Road Utica, New York 13502

Phone: [phone] Fax: [phone]

Contact Person: Carrie Engleman Date Prepared: December 20, 2019

#### II. DEVICE NAME

| Device Name: | Y-Knot® OneStep™ Anchor |
|----------------------|------------------------------------------------|
| Classification Name: | Fastener, fixation, nondegradable, soft tissue |
| Regulatory Class: | Class II, per 21 CFR Part 888. 3040 |
| Product Codes: | MBI |

#### III. PREDICATE/ LEGALLY MARKETED DEVICE

| Device Name: | Y-Knot® Flex All-Suture Anchor |
|---------------|--------------------------------|
| Company Name: | ConMed Linvatec |
| 510(k) #: | K131035 |

#### DEVICE DESCRIPTION IV.

The CONMED Y-Knot® OneStep™ Anchors are manufactured from High Strength Flat Braided Suture and threaded with either one or two #2 (5 metric) Hi-Fi® suture strands or suture ribbon. Y-Knot® OneStep anchors are provided single-use, sterile, and preloaded onto a disposable inserter. The anchors, sutures and disposable inserter are EO Sterilized.

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

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

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The devices may be used in either arthroscopic or open surgical procedures. After 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 VII. PREDICATE DEVICE

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

| | Y-Knot® OneStep™<br>Anchor Proposed Device | Y-Knot® Flex All-Suture<br>Anchor, w/ Two #2 (5<br>metric) Hi-Fi Sutures,<br>1.8mm<br>Predicate Device |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The CONMED Y-Knot®<br>OneStep™ Anchor System<br>are manufactured from High<br>Strength Flat Braided Suture<br>and threaded with either one<br>or two #2 (5 metric) Hi-Fi®<br>suture strands or suture<br>ribbon. Y-Knot OneStep<br>anchors are provided single-<br>use, sterile, and preloaded<br>onto a disposable inserter.<br>The anchors, sutures and<br>disposable inserter are EO<br>Sterilized. | ConMed Linvatec Y-Knot®<br>Flex All-Suture Anchor is<br>manufactured from High<br>Strength Flat Braided<br>Suture and threaded with<br>either one or two #2 (5<br>metric) Hi-Fi® suture<br>strands. Y-Knot anchors are<br>provided single-use, sterile,<br>and preloaded on a<br>disposable inserter. The<br>anchor, suture and<br>disposable inserter are EO<br>Sterilized. |
| Intended Use | The non-absorbable implant<br>is intended to reattach soft<br>tissue to bone in orthopedic<br>surgical procedures. | The non-absorbable suture<br>anchor is intended to<br>reattach soft tissue to bone<br>in orthopedic surgical<br>procedures. |
| Indication for Use | The devices may be used in<br>either arthroscopic or open<br>surgical procedures. After<br>suture is anchored to the<br>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 | The devices may be used in<br>either arthroscopic or open<br>surgical procedures. After<br>suture is anchored to the<br>bone, it may be<br>used to reattach soft tissue,<br>such as ligaments, tendons,<br>or joint capsules to the |
| | thereby stabilizes the | bone. The suture anchor |
| | damaged soft tissue, in | systems thereby |
| | conjunction with | stabilize the damaged soft |
| | appropriate postoperative | tissue, in conjunction with |
| | immobilization, throughout | appropriate postoperative |
| | the healing period. | immobilization, throughout |
| | | the healing period. |
| Contraindications | 1. Pathological conditions<br>of bone which would<br>adversely affect Y-Knot<br>anchors.<br>2. Pathological conditions in<br>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<br>to eliminate, adequate<br>implant support or retard<br>healing.<br>4. Conditions which tend to<br>limit the patient's ability<br>or willingness to restrict<br>activities or follow<br>directions during the<br>healing period.<br>5. Attachment of artificial<br>ligaments or other<br>implants.<br>6. Foreign body sensitivity,<br>known or suspected<br>allergies to implant and/or<br>instrument materials.<br>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.<br>8. Patients with active sepsis<br>or infection. | Same |
| Components | All-Suture Anchor<br>Disposable Inserter<br>Suture | All-Suture Anchor<br>Disposable Inserter<br>Suture |

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| Technological<br>Characteristics | Flat-braid suture anchor<br>One or two #2 sutures or<br>ribbon<br>Pilot hole drilled with<br>inserter<br>Press-fit insertion<br>Expandable design<br>Flexible Inserter | Flat-braid suture anchor<br>Two #2 sutures<br>Pilot hole drilled with<br>disposable drill bit<br>Press-fit insertion<br>Expandable design<br>Flexible Inserter |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Single Use/<br>Reusable | Single-Use | Same |
| Sterilization | EtO<br>Sterility Assurance Level<br>(SAL) of 10-6 | Same |
| Biocompatibility | Materials are Biocompatible<br>and met the requirements of<br>an acceptable biological<br>evaluation per ISO 10993-1<br>and FDA Guidance | Same |
| Shelf Life | 18-months | 5-years |

### PERFORMANCE DATA

Testing has been completed to demonstrate that the Y-Knot® OneStep™ 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:

Verification Testing

- Reliability ●
- Fixation/Pull Out ●
- Displacement ●
- Cyclic ●
- Sterilization ●
- Pyrogen
- Biocompatibility ●
- Shelf-life ●
- Transportation ●
- Post Aging Functional Testing ●
- MR Safety Testing ●

Validation Testing

- User Validation .
- Packaging And Labeling .

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## VIII. CONCLUSION

Y-Knot® OneStep™ Anchor is substantially equivalent in design, materials, intended use, principles of operation, and technical characteristics to the predicate Y-Knot® Flex All-Suture Anchor. Based upon the findings of our performance testing, the differences present no new issues of safety and efficacy, and the Y-Knot® OneStep™ Anchor is substantially equivalent to the Y-Knot® Flex All-Suture Anchor (K131035).