NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER

K130351 · Pivot Medical, Inc. · MBI · Mar 14, 2013 · Orthopedic

Device Facts

• Record ID: K130351
• Device Name: NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER
• Applicant: Pivot Medical, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Mar 14, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NanoTack Suture Anchor is intended for the fixation of soft tissue to bone in the hip, and is indicated for the reattachment of hip labrum to the acetabulum.

Device Story

NanoTack Suture Anchor 1.4mm is a non-degradable bone fixation device; consists of PEEK-OPTIMA polymer anchor attached to UHMWPE blue co-braid #1 suture; pre-assembled to a Flex stainless steel inserter. Used by surgeons in clinical settings for hip labrum reattachment to the acetabulum. Modification from predicate involves laser-cut pattern on distal end of inserter shaft to allow flexibility through curved guides. Device is single-use and sterile. Provides secure soft tissue-to-bone fixation to facilitate healing.

Clinical Evidence

Bench testing only. Performance testing included insertion strength and anchor strength to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Materials: PEEK-OPTIMA polymer anchor, UHMWPE suture, stainless steel inserter. Design: 1.4mm suture anchor with laser-cut flexible inserter shaft. Single-use, sterile. Mechanical fixation principle.

Indications for Use

Indicated for reattachment of hip labrum to the acetabulum in patients requiring soft tissue-to-bone fixation in the hip.

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

• NanoTack Suture Anchor 1.4mm (K110473)

Submission Summary (Full Text)

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NanoTack Suture Anchor Premarket Notification - Special 510(k)

#### Section 5. 510(k) Summary

MAR 1 4 2013

510(k) Owner Pivot Medical Inc. 247 Humboldt Court Sunnyvale CA 94089 Phone: [phone] Fax: [phone] Jon Cook Director Regulatory Affairs and Quality Assurance

FDA Contact

Jon Cook Director Regulatory Affairs and Quality Assurance Pivot Medical 247 Humboldt Court Sunnyvale CA 94089 Telephone: [phone] Facsimile: [phone] Email: [e-mail]

Date Summary Prepared: February 8, 2013

Device Name

Trade Name: NanoTack Suture Anchor 1.4mm with Flex Inserter Common Name: Bone Anchor Classification Name: Smooth or threaded metallic bone fixation fastener Regulation number: 21 CFR888.3040 Product Code: MBI

Predicate Device

NanoTack Suture Anchor 1.4mm - K110473

#### Device Description

The Pivot NanoTack Suture Anchor 1.4mm is a non-degradable suture anchor manufactured from PEEK-OPTIMA® polymer attached to a non-degradable ultra high molecular weight polyethylene (UHMWPE) blue co-braid #1 suture that is pre-assembled to a Flex stainless steel Inserter. The NanoTack Suture Anchor 1.4mm with Flex Inserter is provided as a single use sterile device.

#### Intended Use / Indication for Use

The NanoTack Suture Anchor is intended for the fixation of soft tissue to bone in the hip, and is indicated for the reattachment of hip labrum to the acetabulum.

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#### Summary of Technological Characteristics

The NanoTack Suture Anchor 1.4mm with Flex Inserter is substantially equivalent in design, materials, and function to the NanoTack Suture Anchor 1.4mm with Inserter (K110473). The only difference between the NanoTack Suture Anchor 1.4mm with Flex Inserter and the predicate is the laser cut pattern on the distal end of the Inserter shaft which allows the Inserter to flex through a curved quide.

#### Summary of Performance Testing

The performance testing conducted demonstrates that the insertion and fixation properties of the NanoTack Suture Anchor 1.4mm with Flex Inserter are substantially equivalent to the predicate device. Pre-clinical testing includes insertion strength and anchor strength.

#### Summary of Substantial Equivalence

The NanoTack Suture Anchor 1.4mm with Flex Inserter design, materials, and technology is substantially equivalent to the NanoTack Suture Anchor 1.4mm cleared in K110473. The modification to the inserter shaft does not raise new questions regarding the safety and effectiveness of the NanoTack Suture Anchor 1.4mm. Based upon the indications for use, technological characteristics, and comparison to the predicate device, the Pivot NanoTack Suture Anchor 1.4mm with Flex Inserter is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. 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 Center - WO66-G609 Silver Spring, MD 20993-0002

March 14, 2013

Pivot Medical Incorporated % Mr. Jon Cook Director Regulatory Affairs and Quality Assurance 247 Humboldt Court Sunnyvale, California 94089

Re: K130351

Trade/Device Name: NanoTack Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 8, 2013 Received: February 12, 2013

Dear Mr. Cook:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 - Mr. Jon Cook

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/CDRHOffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Erin Diceith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Pivot Medical

K130351

NanoTack Suture Anchor Premarket Notification - Special 510(k)

### Section 4.

Indications for Use

510(k) Number (if known): K | 30351

Device Name: NanoTack Suture Anchor

Indications for Use:

The NanoTack Suture Anchor is indicated for the reattachment of hip labrum to the acetabulum.

Prescription Use × (Part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter-Use (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)

Casey L. Hanley, Ph.D.
Division of Orthopaedic Devices