Ventix Link Knotless Anchor with Inserter

K180274 · Cayenne Medical, Inc. · MBI · Mar 21, 2018 · Orthopedic

Device Facts

• Record ID: K180274
• Device Name: Ventix Link Knotless Anchor with Inserter
• Applicant: Cayenne Medical, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Mar 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cayenne Medical, Inc. Ventix™ Link Knotless Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications: Shoulder - Acromioclavicular separation repairs - Deltoid repairs - Rotator cuff repairs - Biceps tenodesis Knee - Extra-capsular repairs - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament - Patellar realignment and tendon repairs - Illiotibial band tenodesis - Supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation. Foot and Ankle - Medial or lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions

Device Story

Ventix™ Link Knotless Anchor is a sterile, single-use, manually operated orthopedic implant for reattaching soft tissue to bone. Device consists of a PEEK anchor preloaded on a disposable stainless steel/ABS plastic inserter. Used by surgeons in arthroscopic, open, or limited-access procedures. Surgeon inserts anchor into pre-drilled bone hole to secure sutures (Zimmer Biomet TRU-LINK, MaxBraid, or Force Fiber). Knotless design eliminates need for manual knot tying, simplifying fixation. Provides mechanical stability for tendon/ligament repairs. Benefits include reduced surgical time and secure soft tissue fixation.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing, including mechanical pull-out strength, biocompatibility, pyrogenicity, shelf-life, and MRI safety assessments.

Technological Characteristics

Anchor material: PEEK. Inserter: surgical grade stainless steel shaft, ABS plastic handle. Dimensions: 4.75mm and 5.5mm anchor sizes; 155mm shaft length, 4.76mm shaft diameter. Manual insertion mechanism. Sterile, single-use. Compatible with specific USP #1 or #2 sutures.

Indications for Use

Indicated for soft tissue-to-bone reattachment in shoulder (AC separation, deltoid, rotator cuff, biceps tenodesis), knee (extra-capsular repairs, patellar realignment, IT band tenodesis, ACL supplementary fixation), and foot/ankle (instability repairs, Achilles tendon repairs).

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

• Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 21, 2018

Cayenne Medical, Inc. Shima Hashemian QA/RA Associate Director 16597 N. 92nd Street, Suite 101 Scottsdale, Arizona 85260

Re: K180274

Trade/Device Name: Ventix™ Link Knotless Anchor with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: January 30, 2018 Received: January 31, 2018

Dear Ms. Hashemian:

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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## Page 2 - Ms. Shima Hashemian

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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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# Indications for Use

Device Name: VentixTM Link Knotless Anchor with Inserter

Indications for Use:

The Cayenne Medical, Inc. Ventix™ Link Knotless Anchors are intended to be used for the reattachment of soft tissue to bone for the following indications:

#### Shoulder

- Acromioclavicular separation repairs ●
- Deltoid repairs
- Rotator cuff repairs
- Biceps tenodesis

#### Knee

- Extra-capsular repairs ●
- o Medial collateral ligament
- o Lateral collateral ligament
- Posterior oblique ligament O
- Patellar realignment and tendon repairs
- Illiotibial band tenodesis ●
- Supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation.

#### Foot and Ankle

- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 510(k) Summary

# Cayenne Medical, Inc.

Ventix™ Link Knotless Anchor with Inserter

#### Administrative Information

| Date of summary: | 03/19/2018 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer Name: | Cayenne Medical, Inc.<br>16597 N. 92nd St., Suite 101<br>Scottsdale, AZ 85260<br>Telephone [phone]<br>FAX [phone] |
| Official Contact: | Shima Hashemian<br>16597 N. 92nd St., Suite 101<br>Scottsdale, AZ 85260<br>[e-mail]<br>Telephone [phone]<br>FAX [phone] |

#### Device Name

| Classification Name: | Smooth or threaded metallic bone fixation fastener |
|-------------------------|----------------------------------------------------|
| Trade/Proprietary Name: | Ventix™ Link Knotless Anchor with Inserter |
| Common Name: | Suture Anchor |

#### Device Classification

FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for Fastener, Fixation, Nondegradable, and Soft Tissue is MBI.

Primary Predicate: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897)

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# Device Description

The Ventix™ Link Knotless Anchor is a sterile, manually operated, single procedure anchor device for reattachment of soft tissue to bone. The anchor is preloaded on a disposable inserter. The Ventix™ Link Knotless Anchor incorporates design features that facilitate anchor placement under arthroscopic, open or limited access conditions in soft tissue to bone reattachment procedures. The Ventix™ Link Knotless Anchor is offered in two sizes, 4.75mm and 5.5mm, and can receive up to six suture ends. The anchor is made out of PolyEtherEtherKetone (PEEK). Zimmer Biomet TRU-LINK™, MaxBraid™ and/or MaxBraid™ BroadBand™ Tape, or Force Fiber® USP #1 or #2 sutures are to be only used with the Ventix™ Link Knotless Anchors.

The disposable inserter has a working shaft length (from handle to distal tip of anchor) of 6.1 in (155 mm) with an outer shaft diameter of 0.1875 in (4.76 mm). The inserter shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic. The inserter facilitates the placement of the implant into a hole prepared in the bone.

#### Indications for Use

The Cayenne Medical, Inc. Ventix™ Link Knotless Anchor is intended to be used for fixation of soft tissue to bone for the following indications:

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#### Shoulder

- Acromioclavicular separation repairs
- Deltoid repairs
- Rotator cuff repairs
- Biceps tenodesis

#### Knee

- Extra-capsular repairs ●
- Medial collateral ligament O
- Lateral collateral ligament O
- o Posterior oblique ligament
- Patellar realignment and tendon repairs
- Illiotibial band tenodesis
- Supplementary fixation when used in conjunction with a primary fixation device in ACL repair and reconstruction surgical procedures requiring graft fixation.

#### Foot and Ankle

- Medial or lateral instability repairs/reconstructions ●
- Achilles tendon repairs/reconstructions ●

#### Technological Differences

The Ventix™ Link Knotless Anchor is similar in its indication for use, intended use, design features, technology, and materials to the predicate device.

The subject Ventix™ Link device has the same intended use and similar indication for use as the predicate device, the Smith & Nephew FOOTPRINT Ultra PK Suture Anchor.

The subject device differs from the predicate device, Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, in terms of design features and the offered sizes.

#### Non-clinical Testing

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence is included. The results of mechanical testing (pull-out strength), and assessment of biocompatibility, pyrogenicity, shelf-life and MRI safety demonstrated that the functionality and safety of the Ventix™ Link Knotless Anchor are adequate for its intended use and determination of substantial equivalence to the predicate device.

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# Clinical Testing

Clinical testing was not used to establish substantial equivalence to predicate device.

# Equivalence to Marketed Product

Cayenne Medical, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the Ventix™ Link Knotless Anchor is substantially equivalent in indication and performance to the legally marketed predicate device, Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897). The substantial equivalence of Ventix™ Link Knotless Anchor is based on similarities in indications for use, intended use, design features, technology, and materials to the predicate device.