HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)

K131974 · Depuy Mitek, A Johnson & Johnson Company · MAI · Jul 25, 2013 · Orthopedic

Device Facts

• Record ID: K131974
• Device Name: HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: MAI · Orthopedic
• Decision Date: Jul 25, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• 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 BR 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 clinical settings to facilitate soft tissue reattachment. By providing a knotless fixation mechanism, the anchor simplifies the surgical procedure, potentially reducing operative time and improving fixation security. The device is manufactured from 'biocryl rapide' material.

Clinical Evidence

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

Technological Characteristics

Cannulated, threaded bone anchor; material: biocryl rapide; size: 6.5mm; delivery: disposable inserter driver; sterilization: not specified.

Indications for Use

Indicated for patients requiring soft tissue to bone reattachment in the shoulder, specifically for rotator cuff repair and biceps tenodesis.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Mitek Healix Advance Knotless BR Anchor (4.75 and 5.5mm) (K130917)

Submission Summary (Full Text)

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#### K131974 (1/2)

| | never stop moving • | |
|----------------------------------------|---------------------|--|
| Mitek Inc<br>a Johnson&Johnson company | | |

#### PRODUCT: HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5mm) SUBMISSION DATE: June 27, 2013 SUBMISSION TYPE: SPECIAL

## 510(k) SUMMARY

# JUL 2 5 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<br><br>Telephone: [phone]<br>Facsimile: 508-977-6911<br>e-mail: [e-mail] |
| Date Prepared | June 27, 2013 |
| Name of Medical<br>Device | Proprietary Name: HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5mm)<br>Classification Name: Fastener, Fixation, Biodegradable, Soft tissue<br>Common Name: Bone Anchor |
| Substantial<br>Equivalence | The HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5mm) is substantially equivalent to:<br>• K130917 Mitek Healix Advance Knotless BR Anchor (4.75 and 5.5mm) |
| Device<br>Classification | Single/multiple component metallic bone fixation appliances and accessories, classified as a Class<br>II device, regulated under 21 CFR 888.3030, product code MAI. |
| Device<br>Description | The proposed Healix Advance Knotless Anchor is a one piece implantable cannulated, threaded<br>anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable<br>inserter driver device. The proposed anchors will be offered in a 6.5 mm size. The proposed 6.5<br>mm Healix Advance Knotless BR Anchor is manufactured from "biocryl rapide" material. |
| Indications for<br>Use | The Healix Advance Knotless Anchors are indicated for use in the following procedures for<br>reattachment of soft tissue to bone:<br><br>Shoulder<br>• Rotator Cuff<br>• Biceps Tenodesis |

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## K131974 (2/2)

| DePuy<br>Mitek Inc.<br>never stop moving | PRODUCT: HEALIX ADVANCE KNOTLESS<br>BR ANCHOR (6.5mm)<br>SUBMISSION DATE: June 27, 2013<br>SUBMISSION TYPE: SPECIAL |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------|

| Comparison of<br>Technological<br>Characteristics | The proposed Healix Advance Knotless BR Anchors will have the same design as compared to the<br>predicate devices (4.75mm and 5.5mm) but will be larger in size (6.5mm). Both the proposed<br>and predicate Healix Advance Knotless BR Anchors are molded from the same BR "biocryl<br>rapide" material. No new technological characteristics were introduces as a result of the proposed<br>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 & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

#### 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

DePuy Mitek, Incorporated % Ms. Kristine Christo Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767 July 25, 2013

Re: K131974

Trade/Device Name: Healix Advance Knotless BR Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: June 27, 2013 Received: June 28, 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

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#### Page 2 - Ms. Kristine Christo

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Salcty/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 -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

510(k) Number (if known): K131974

Device Names: Healix Advance Knotless BR 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 .

ಳ Prescription Use

AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

(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