CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5

K112876 · Cayenne Medical, Inc. · MBI · Dec 15, 2011 · Orthopedic

Device Facts

• Record ID: K112876
• Device Name: CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5
• Applicant: Cayenne Medical, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Dec 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cayenne Medical, Inc. CuffLink Knotless Anchors are intended for use for the reattachment of soft tissue to bone for shoulder procedures such as Rotator Cuff Repairs.

Device Story

CuffLink Knotless Anchor is a sterile, manually operated, single-procedure suture anchor; used for reattaching soft tissue to bone during arthroscopic or open shoulder rotator cuff repairs. Device consists of an anchor body mounted on an inserter; available in PEEK or PEEK/titanium alloy configurations; some models feature a self-punching metal tip. Surgeon operates device to secure soft tissue to bone; knotless design eliminates need for manual knot tying. Mechanical testing demonstrates superior ultimate pull-out strength compared to predicate devices. Benefits include simplified anchor placement and secure soft tissue fixation.

Clinical Evidence

Bench testing only. Mechanical testing was performed to evaluate the ultimate pull-out strength of the CuffLink Knotless Anchor and Inserter, demonstrating performance significantly higher than that of the predicate device.

Technological Characteristics

Materials: PEEK anchor body, titanium alloy tip. Dimensions: 4.5mm and 5.5mm sizes. Principle: Suture anchor for soft tissue-to-bone fixation. Operation: Manually operated, sterile, single-procedure. Connectivity: None. Software: None.

Indications for Use

Indicated for reattachment of soft tissue to bone in shoulder procedures, specifically rotator cuff 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)
• DePuy Mitek GII Anchors (K041115)

Submission Summary (Full Text)

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510(k) Summary

# 510(k) Summary

Cayenne Medical, Inc. CuffLink™ Knotless Anchor

510(k) Number:

## K112876

### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Cayenne Medical, Inc.<br>16597 N. 92nd St., Suite 101<br>Scottsdale, AZ 85260<br>Telephone [phone]<br>FAX [phone] |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Kereshmeh Shahriari<br>16597 N. 92nd St., Suite 101<br>Scottsdale, AZ 85260<br>[e-mail]<br>Telephone [phone]<br>FAX [phone] |
| 510(k) Summary Preparation<br>Date | September 22nd, 2011 |
| DEVICE NAME | |
| Classification Names: | Smooth or threaded metallic bone fixation fastener |
| Trade/Proprietary Name: | CuffLink™ Knotless Anchor |
| Common Name: | Suture Anchor |

### DEVICE CLASSIFICATION

FDA has classified bone screws as Class II devices (21 CFR 888.3040). The product code for CuffLink Knotless Anchor is MBI. The subsequent product code is HWC. These devices are reviewed by the Orthopedic Joint Devices Branch.

## INTENDED USE

The Cayenne Medical, Inc. CuffLink Knotless Anchors are intended for use for the reattachment Revised Page 17 of 142

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112876

510(k) Summary

of soft tissue to bone for shoulder procedures such as Rotator Cuff Repairs.

#### DEVICE DESCRIPTION

The CuffLink™ Knotless Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone in procedures such as shoulder rotator cuff repair. The anchor is mounted on an inserter. The CuffLink Knotless Anchor incorporates design features that facilitate suture anchor placement under arthroscopic or open, limited access conditions in soft tissue to bone reattachment procedures such as shoulder rotator cuff repair. The anchor is offered in two different configurations, with or without a self-punching (SP) metal tip (PEEK anchor body and titanium alloy tip and PEEK anchor is offered in two different sizes. 4.5mm and 5.5mm. The PEEK and titanium alloy anchor is offered in one size, 4.5mm.

Mechanical testing was performed on the CuffLink Knotless Anchor and Inserter. It was shown that ultimate pull-out strength is significantly higher than that of a predicate device.

## EQUIVALENCE TO MARKETED PRODUCT

Cavenne Medical. Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the CuffLink Knotless Anchor is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897) and DePuy Mitek GII Anchors (K041115).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Cayenne Medical, Inc. % Ms. Kereshmeh Shahriari Senior Directory of Regulatory Affairs, Quality Assurance and Compliance 16597 North 92nd Street, Suite 101 Scottsdale, Arizona 85260

DEC 1 5 2011

Re: K112876

Trade/Device Name: Cufflink™ Knotless Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI. HWC Dated: October 18, 2011 Received: October 31, 2011

Dear Ms. Shahriari:

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. Ilsting 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 (reporting of medical device-related adverse events) (2 i CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kereshmeh Shahriari

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for. the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K112876

510(k) Premarket Notification

CuffLink™ Knotless Anchor

Indications for Use

510(k) Number (if known): K112876

Device Name: CuffLink™ Knotless Anchor

Indications for Use:

The Cayenne Medical, Inc. CuffLink Knotless Anchors are intended for use for the reattachment of soft tissue to bone for shoulder procedures such as Rotator Cuff Repairs.

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)

March Links and Children Marcel Comments of the Children Comments on the Children and Childred Children and Children Children Children Children Childer Children Childer Child

Concurrence of CDRH, Office of Device Evaluation (ODE)

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vision Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

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