4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3

K133794 · Depuy Mitek, A Johnson & Johnson Company · MAI · Feb 4, 2014 · Orthopedic

Device Facts

• Record ID: K133794
• Device Name: 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: MAI · Orthopedic
• Decision Date: Feb 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows: 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, Medial 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

Threaded suture anchor preloaded on disposable inserter; used for soft tissue-to-bone fixation. Available in absorbable BR or non-absorbable PEEK materials with Permacord non-absorbable suture. Used by surgeons in clinical settings (OR) for orthopedic repairs. Device provides mechanical fixation of soft tissue to bone; surgeon secures tissue using anchor and suture. Benefits include stable fixation during healing process.

Clinical Evidence

Bench testing only. Verification activities included pull-out testing, insertion and failure torque testing, in-vitro testing, and suture testing per USP standards. No clinical data presented.

Technological Characteristics

Threaded suture anchor; materials: absorbable BR or non-absorbable PEEK; suture: non-absorbable Permacord. Sterile, single-use, disposable inserter assembly. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for patients requiring soft tissue to bone fixation in shoulder, foot/ankle, knee, elbow, and hip procedures, including rotator cuff, Bankart, SLAP, biceps, ligament, and labral repairs, in conjunction with post-operative immobilization.

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 Advance BR Anchor with Orthocord suture (K120078)
• Healix Advance PEEK Anchor with Orthocord suture (K120449)
• Gryphon T BR Anchor with Orthocord suture (K100012, K073412)

Reference Devices

• Force Fiber White/Black Co-Braid (K070673)
• Force Fiber Blue Braid (K092533)
• Force Fiber White/Green Co-Braid (K100506)

Submission Summary (Full Text)

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# FEB - 4 2014

·

### SECTION 2 - 510(k) SUMMARY

Healix Advance"" Anchor with Permacord™

| Submitter's<br>Name and<br>Address | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767<br><br>Date Prepared: December 11, 2013 | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tatyana Korsunsky<br>Regulatory Affairs Specialist<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: a) Healix Advance™ BR Anchor with Permacord™<br>b) Healix Advance™ PEEK Anchor with Permacord™<br><br>Classification Name: a) Single/multiple component metallic bone fixation<br>appliances and accessories<br>b) Smooth or threaded metallic bone fixation fasteners<br><br>Common Name: Suture Anchor | |
| Substantial<br>Equivalence | The Healix Advance™ Anchor with Permacord™ is substantially equivalent to:<br>• K120078 Healix Advance™ BR Anchor with Orthocord® suture<br>• K120449 Healix Advance™ PEEK Anchor with Orthocord® suture<br>• K100012, K073412 Gryphon™ T BR Anchor with Orthocord® suture<br><br>The following predicate devices were referenced:<br>• K070673 Force Fiber® White/Black Co-Braid. Teleflex<br>• K092533 Force Fiber® Blue Braid. Teleflex<br>• K100506 Force Fiber® White/Green Co-Braid. Teleflex | |
| Device<br>Classification | ➤ Healix Advance BR anchor is classified as:<br>Single/multiple component metallic bone fixation appliances and accessories,<br>classified as Class II, product code MAI, regulated under 21 CFR 888.3030.<br><br>➤ Healix Advance PEEK anchor is classified as:<br>Smooth or threaded metallic bone fixation fasteners, classified as Class II, product<br>code HWC, regulated under 21 CFR 888.3040. | |
| Device<br>Description | The Healix Advance" Anchor with Permacord™ suture is a threaded suture anchor<br>preloaded on a disposable inserter assembly intended for fixation soft tissue to bone.<br>Healix Advance Anchors are available in absorbable BR and non-absorbable PEEK<br>materials. Permacord suture is a non-absorbable suture that conforms to USP, except<br>for oversized diameter. Healix Advance Anchors with Permacord are provided sterile<br>and is for single use only. | |
| Technological<br>Characteristics | The proposed Healix Advance Anchors with Permacord suture have the same anchor<br>materials and design as predicate Healix Advance Anchors (K120078, K120449). The<br>proposed device principal operation is the same as predicate Healix Advance Anchors<br>(K120078. K120449) and Gryphon" BR (K100012) anchors. The Permacord suture<br>has the same design and materials as Teleflex's Force Fiber suture (K070673,<br>K092533, K100506), and conforms to USP, except for oversized diameter. | |
| Indications for<br>Use | The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in<br>association with post-operative immobilization as follows: | |
| | 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. |
| Non clinical<br>Testing | Verification activities were performed on the implant and / or its predicates. Testing<br>assessments include pull out testing, insertion and failure torque, in-vitro testing and<br>suture testing per USP. | |
| Safety and<br>Performance | Results of performance testing have demonstrated that the proposed devices are<br>suitable for their intended use. | |
| | Based on similarities in the indications for use, technological characteristics, and<br>performance in comparison to the predicate devices, the proposed Healix Advance<br>Anchor with Permacord suture has shown to be substantially equivalent to the<br>predicate devices under the Federal Food, Drug and 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 emblem resembling an eagle or bird with three wing-like shapes.

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

February 4, 2014

DePuy Mitek, a Johnson & Johnson company Ms. Tatyana Korsunsky Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767

Re: K133794

Trade/Device Name: Healix Advance™ Anchor with Permacord™ suture Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: December 11, 2013 Received: December 13, 2013

Dear Ms. Korsunsky:

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. Tatyana Korsunsky

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" (21 CFR 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Vincent訂房Devlin -S

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): K133794

Device Name: Healix Advance™ Anchor with Permacord™suture

#### Indications for Use:

The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:

| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-<br>Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral<br>Reconstruction; |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Foot/Ankle: | Lateral Stabilization, Medial 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 |
| (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use | |
| (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)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

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