NANOTACK SUTURE ANCHOR 1.4MM

K110473 · Pivot Medical · MBI · May 25, 2011 · Orthopedic

Device Facts

• Record ID: K110473
• Device Name: NANOTACK SUTURE ANCHOR 1.4MM
• Applicant: Pivot Medical
• Product Code: MBI · Orthopedic
• Decision Date: May 25, 2011
• Decision: SESE
• Submission Type: Traditional
• 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 is a non-degradable bone fixation device used for reattaching hip labrum to the acetabulum. Device consists of PEEK-OPTIMA polymer anchor pre-assembled with non-degradable UHMWPE blue co-braid #1 suture on a stainless steel inserter. Provided as single-use sterile device. Operated by surgeons in clinical/OR settings to secure soft tissue to bone. Performance relies on mechanical fixation properties equivalent to predicate anchors.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing demonstrated insertion and fixation properties equivalent to predicate devices.

Technological Characteristics

Materials: PEEK-OPTIMA polymer anchor, UHMWPE suture, stainless steel inserter. Mechanical fixation principle. Single-use, sterile. Dimensions: 1.4mm anchor.

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

• Smith and Nephew BioRaptor 2.3PK Suture Anchor (K071586)
• Biomet Sleeve with ZipLoop Fixation Device (K080088 and K101063)

Submission Summary (Full Text)

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

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 16, 2011

Device Name

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

Predicate Devices

Smith and Nephew BioRaptor 2.3PK Suture Anchor - K071586

Biomet Sleeve with ZipLoop™ Fixation Device - K080088 and K101063

### Device Description

The Pivot NanoTack Suture Anchor 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 stainless steel Inserter. The NanoTack Suture Anchor with Inserter is provided as a single-use sterile device.

## 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.

Confidential

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Image /page/1/Picture/1 description: The image shows the logo for Pivot Medical. The logo consists of the word "pivot" in a sans-serif font, with the "o" replaced by a stylized sphere. Below the word "pivot" is the word "MEDICAL" in a smaller, sans-serif font. The logo is black and white.

# Summary of Technological Characteristics

The Pivot NanoTack Suture Anchor is substantially equivalent in design, materials, and function to the BioRaptor 2.3PK (K071586) and the Biomet Sleeve with ZipLoop (K080088 and K101063) predicate devices. The only difference between the NanoTack Suture Anchor and the BioRaptor 2.3PK is that the NanoTack utilizes a smaller size suture. The only difference between the NanoTack Suture Anchor and the Biomet Sleeve with ZipLoop is that the NanoTack anchor body is PEEK and the Biomet anchor body is polyester suture.

# Summary of Performance Testing

The performance testing conducted demonstrates that the insertion and fixation properties of the NanoTack Suture Anchor are substantially equivalent to the Smith and Nephew BioRaptor 2.3PK and the Biomet Sleeve with ZipLoop anchors.

# Summary of Substantial Equivalence

Based upon the indications for use, technological characteristics, and comparison to the predicate devices, the Pivot NanoTack Suture Anchor is substantially equivalent to predicate devices.

Confidential

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

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

MAY 25 2011

Re: K110473

Trade/Device Name: NanoTack Suture Anchor 1.4mm Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 17, 2011 Received: May 19, 2011

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

E.S.Keith

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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Pivot Medical

# Indications for Use

510(k) Number (if-known): K110473

NanoTack Suture Anchor Device Name:

・

Indications for Use:

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

Prescription Use X (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)

El Kutt

(Division Sign-Off) (Division Sign-of-Surgical, Orthopedic, Divisionative Devices

510(k) Number K110473

Confidential