HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)

K131683 · Depuy Mitek, Inc., A Johnson and Johnson Company · MBI · Jun 27, 2013 · Orthopedic

Device Facts

• Record ID: K131683
• Device Name: HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)
• Applicant: Depuy Mitek, Inc., A Johnson and Johnson Company
• Product Code: MBI · Orthopedic
• Decision Date: Jun 27, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Healix Advance Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone: Shoulder Rotator Cuff . Biceps Tenodesis .

Device Story

The Healix Advance Knotless PEEK Anchor is a one-piece, cannulated, threaded implant designed to secure soft tissue to bone. It is provided pre-loaded on a disposable inserter driver. The device is used by surgeons in orthopedic procedures, specifically for shoulder rotator cuff repair and biceps tenodesis. The anchor is screwed into the bone to provide fixation without the need for knots. By facilitating secure reattachment of soft tissue to bone, the device aids in the healing and stabilization of the affected joint.

Clinical Evidence

Bench testing only. Performance and safety were verified through non-clinical design verification and validation activities, including insertion torque, torque to failure, and anchor pullout testing.

Technological Characteristics

One-piece, cannulated, threaded bone anchor. Material: PEEK (Polyetheretherketone). Size: 6.5mm. Provided with a disposable inserter driver. Class II device, product code MBI, 21 CFR 888.3040.

Indications for Use

Indicated for reattachment of soft tissue to bone in shoulder procedures, specifically rotator cuff repair and biceps tenodesis.

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

• Mitek Healix Advance Knotless PEEK Anchor (K130539)

Submission Summary (Full Text)

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| | K131683 (1/2) | | | | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | | PRODUCT:<br>SUBMISSION TYPE: SPECIAL | HEALIX ADVANCE KNOTLESS<br>PEEK ANCHOR (6.5mm)<br>SUBMISSION DATE: June 6, 2013 | |
| 510(k) SUMMARY | | | | JUN 2 7 2013 | |
| Submitter: | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 | | | | |
| Contact Person | Kristine Christo<br>Manager, Regulatory Affairs<br>DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA | | Facsimile: | Telephone: [phone]<br>508-977-6911<br>e-mail: [e-mail] | |
| Date Prepared | June 6, 2013 | | | | |
| Name of Medical<br>Device | Proprietary Name:<br>Classification Name:<br>Common Name: | Bone Anchor | Fastener, Fixation, Biodegradable, Soft tissue | HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5mm) | |
| Substantial<br>Equivalence | | | | The HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5mm) is substantially equivalent to:<br>1/120520 } Ctole Llacky Advance Kmatlegg DDCV Amabon (4,76 and 5,5 mm) | |

■ K130539 Mitek Healix Advance Knotless PEEK Anchor (4.75 and 5.5mm)

Device Fastener, Fixation, Nondegradable, Soft Tissue, classified as Class II, product code MBI regulated Classification under 21 CFR 888.3040.

Device The proposed Healix Advance Knotless Anchor is a one piece implantable cannulated, threaded Description anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchors will be offered in a 6.5 mm size. The proposed 6.5 mm Healix Advance Knotless PEEK Anchor is manufactured from PEEK (Polyetheretherketone) material.

Indications for The Healix Advance Knotless Anchors are indicated for use in the following procedures for Use reattachment of soft tissue to bone:

Shoulder

- Rotator Cuff .
- . Biceps Tenodesis

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| Image: DePuy logo | K131683 (2/2) | |
|-------------------|------------------|------------------------------------------------|
| never stop moving | PRODUCT: | HEALIX ADVANCE KNOTLESS<br>PEEK ANCHOR (6.5mm) |
| | SUBMISSION DATE: | June 6, 2013 |
| | SUBMISSION TYPE: | SPECIAL |

| Comparison of<br>Technological<br>Characteristics | The proposed Healix Advance Knotless PEEK Anchors will have the same design as comp<br>the predicate devices (4.75mm and 5.5mm) but will be larger in size (6.5mm). Both the pr<br>and predicate Healix Advance Knotless PEEK Anchors are molded from the same<br>(polyetheretherketone) material. No new technological characteristics were introduces as<br>of the proposed changes. |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and<br>Performance | Non-clinical Testing<br>Product Design Verification and Design Validation activities, such as, Insertion Torque, Torque to<br>Failure and Anchor Pullout were performed on the proposed implant device. Results of<br>performance and safety testing have demonstrated that the proposed device is substantially<br>equivalent to the predicate devices.<br><br>Based on the indications for use, technological characteristics, and comparison to predicate<br>devices, the proposed 6.5mm Healix Advance Knotless Anchors have been shown to be<br>substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

#### June 27, 2013

Depuy Mitek Incorporated, a Johnson & Johnson Company % Ms. Kristine Christo Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

Re: K131683

Trade/Device Name: Healix Advance Knotless PEEK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 7, 2013 Received: June 10, 2013

Dear Ms. Christo:

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 - Ms. Kristine Christo

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

# Erif Dkeith

For

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

510(k) Number (if known): K131683

Device Names: Healix Advance Knotless PEEK Anchor

Indications for Use: The Healix Advance Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:

Shoulder

Rotator Cuff .

Biceps Tenodesis .

Prescription Use ﮯ AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 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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Casey L. Hanley, Ph.D.

Division of Orthopedic Devices