HEALIX ADVANCE BR ANCHOR

K120078 · Depuy Mitek Inc., Johnson and Johnson Company · MAI · Feb 29, 2012 · Orthopedic

Device Facts

• Record ID: K120078
• Device Name: HEALIX ADVANCE BR ANCHOR
• Applicant: Depuy Mitek Inc., Johnson and Johnson Company
• Product Code: MAI · Orthopedic
• Decision Date: Feb 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HEALIX ADVANCE™ BR Anchor is indicated for: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Mediał Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction; Hip: Capsular Repair, Acetabular Labral Repair.

Device Story

Absorbable threaded suture anchor preloaded on disposable inserter assembly; used for fixation of soft tissue to bone. Operated by surgeons in clinical/surgical settings. Device inserted into bone to secure sutures attached to soft tissue. Provides mechanical fixation during healing process. Benefits patient by facilitating tissue reattachment and stabilization in orthopedic procedures. Provided sterile for single patient use.

Clinical Evidence

Bench testing only. Design verification activities including anchor torque and anchor pull-out testing (at T=0 and in vitro throughout healing period) performed against pre-defined acceptance criteria.

Technological Characteristics

Absorbable threaded suture anchor; preloaded on disposable inserter assembly; single-patient use; sterile. Mechanical fixation principle.

Indications for Use

Indicated for soft tissue to bone fixation in shoulder (rotator cuff, Bankart, SLAP, biceps tenodesis, AC separation, deltoid, capsular/labral repair), foot/ankle (stabilization, Achilles repair), knee (ligament repair, IT band tenodesis), elbow (biceps reattachment, ligament reconstruction), and hip (capsular/labral repair).

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

• Healix BR Anchor and Gryphon BR Anchor (K073412)
• Gryphon T and P BR Anchor (K100012)

Submission Summary (Full Text)

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## SECTION 2 - 510(k) SUMMARY

## HEALIX ADVANCE™ BR Anchor

| Submitter's<br>Name and<br>Address | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Yayoi Fujimaki<br>Regulatory Affairs Senior Associate<br>DePuy Mitek, Inc.<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] |
| Name of<br>Medical Device | Proprietary Name: HEALIX ADVANCE™ BR Anchor<br>Classification Name: Single/multiple component metallic bone fixation appliances and accessories<br>Common Name: Bone Anchor |
| Substantial<br>Equivalence<br>Facility | The HEALIX ADVANCE BR Anchor is substantially equivalent to:<br>■ K073412: Healix BR Anchor and Gryphon BR Anchor<br>■ K100012: Gryphon T and P BR Anchor |
| Device<br>Classification | Single/multiple component metallic bone fixation appliances and accessories,<br>classified as Class II, product code MAI regulated under 21 CFR 888.3030. |

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| Device<br>Description | The HEALIX ADVANCE BR Anchor is absorbable threaded suture anchor preloaded<br>on a disposable inserter assembly intended for fixation soft tissue to bone. The suture<br>options may include needles to facilitate suture passage through tissue. HEALIX<br>ADVANCE BR Anchor is provided sterile and is for single patient use only. | | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications for<br>Use | Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,<br>Capsular Shift or Capsulolabral Reconstruction; | |
| | Foot/Ankle:<br>Knee: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;<br>Medial Collateral Ligament Repair, Lateral Collateral Ligament<br>Repair, Posterior Oblique Ligament Repair, Iliotibial Band<br>Tenodesis; | |
| | Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament<br>Reconstruction: | |
| | Hip: | Capsular repair, Acetabular Labral Repair. | |
| Safety and<br>Performance | Non-clinical Testing<br>Design verification activities, such as Anchor Torque, Anchor Pull Out (at T=0 and in<br>vitro testing throughout the healing period) were performed against pre-defined<br>acceptance criteria according to the intended use, | | |
| | Results of performance testing have demonstrated that the proposed devices are<br>suitable for their intended use.<br>Based on the indications for use, technological characteristics, and comparison to the<br>predicate devices, the proposed HEALIX ADVANCE BR Anchor has shown to be<br>substantially equivalent to the predicate devices under the Federal Food, Drug and<br>Cosmetic Act. | | |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three curved shapes, resembling a person embracing another person, which is the symbol of the department.

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

FEB 2 9 2012

DePuy Mitek Inc. % Ms. Yayoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, Massachusetts 02767

Re: K120078

Trade/Device Name: HEALIX ADVANCE™ 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: January 9, 2012 Received: January 10, 2012

Dear Ms. Fujimaki:

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. Yayoi Fujimaki

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ReportalProblem/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,

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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## Indications for Use

510(k) Number (if known):

Device Name: HEALIX ADVANCE™ BR Anchor

Indications for Use:

The HEALIX ADVANCE™ BR Anchor is indicated for:

| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis,<br>Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or<br>Capsulolabral Reconstruction; |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Foot/Ankle: | Lateral Stabilization, Mediał Stabilization, Achilles Tendon Repair; |
| Knee: | Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior<br>Oblique Ligament Repair, Iliotibial Band Tenodesis; |
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction; |
| Hip: | Capsular Repair, Acetabular Labral Repair. |

Prescription Use _ x

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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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长)20078 510(k) Number_

Premarket Notification: Traditional HEALIX ADVANCE™ BR Anchor