HEALIX ADVANCE Anchor with PERMATAPE Suture

K170639 · Medos International SARL · MAI · May 18, 2017 · Orthopedic

Device Facts

• Record ID: K170639
• Device Name: HEALIX ADVANCE Anchor with PERMATAPE Suture
• Applicant: Medos International SARL
• Product Code: MAI · Orthopedic
• Decision Date: May 18, 2017
• 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 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 Collateral Ligament Reconstruction , 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. Anchors available in absorbable BR or non-absorbable PEEK materials; preloaded with one strand of #2 PERMACORD suture and one strand of PERMATAPE suture. Optional needles facilitate suture passage through tissue. Used by surgeons in clinical settings for orthopedic repairs (shoulder, foot/ankle, knee, elbow, hip). Device provides mechanical fixation of soft tissue to bone; aids in healing by maintaining tissue position during post-operative immobilization. Single-use, sterile device.

Clinical Evidence

Bench testing only. Verification activities included pull-out testing, insertion and failure torque testing, and in-vitro testing. Bacterial endotoxin testing confirmed compliance with established limits.

Technological Characteristics

Threaded suture anchor; materials include absorbable BR and non-absorbable PEEK. Preloaded with #2 PERMACORD and PERMATAPE sutures. Includes disposable inserter assembly; optional needles for tissue passage. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for soft tissue to bone fixation in shoulder, foot/ankle, knee, elbow, and hip procedures requiring post-operative immobilization. Applicable to patients undergoing rotator cuff, ligament, or tendon repairs.

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 Anchor with PERMACORD Suture (K133794)
• Gryphon BR Anchor with Orthocord Suture (K100012, K073412)

Reference Devices

• PERMATAPE Suture (K162247)
• HEALIX ADVANCE PEEK Anchor (K120449)

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

May 18, 2017

Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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

Medos International SARL % Ms. Julie Vafides Project Lead, Regulatory Affairs Depuv Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K170639

Trade/Device Name: HEALIX ADVANCE™ Anchor with PERMATAPE™ 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, MBI Dated: February 28, 2017 Received: March 2, 2017

Dear Ms. Vafides:

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely,

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

## 510(k) Number (if known)

K170639

Device Name

HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture

Indications for Use (Describe)

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

| Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation<br>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,<br>Iliotibial Band Tenodesis |
| Elbow: | Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction , Radial Collateral Ligament Reconstruction |
| Hip: | Capsular Repair, Acetabular Labral Repair |

Type of Use (Select one or both, as applicable)

| <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|--------------------------------------------------------------------|
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) SUMMARY

### HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture

| 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: February 28, 2017 | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Julie Vafides<br>Project Lead, Regulatory Affairs<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br><br>Telephone: [phone]<br>e-mail: [e-mail] | |
| Name of<br>Medical Device | Proprietary Name: a) HEALIX ADVANCE™ BR Anchor with PERMATAPE™<br>Suture<br>b) HEALIX ADVANCE™ PEEK Anchor with<br>PERMATAPE™ Suture<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 PERMATAPE™ Suture is substantially<br>equivalent to:<br>■ K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture<br>■ K100012, K073412 Gryphon™ BR Anchor with Orthocord® Suture<br><br>Reference devices:<br>■ K162247 PERMATAPE™ Suture<br>■ K120449 HEALIX ADVANCE™ PEEK Anchor | |
| Device<br>Classification | > HEALIX ADVANCE™ BR Anchor with PERMATAPE™ Suture 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>> HEALIX ADVANCE™ PEEK Anchor with PERMATAPE™ Suture is classified<br>as:<br>Smooth or threaded metallic bone fixation fasteners, classified as Class II, product<br>code MBI, regulated under 21 CFR 888.3040. | |
| Device<br>Description | The HEALIX ADVANCETM Anchor with PERMATAPETM Suture consists of a<br>threaded suture anchor preloaded on a disposable inserter assembly intended for<br>fixation of one strand of #2 PERMACORDTM suture and one strand of<br>PERMATAPETM suture to bone. HEALIX ADVANCETM Anchors with<br>PERMATAPETM are available in absorbable BR and non-absorbable PEEK materials.<br>Devices with needles will be offered to facilitate suture passage through tissue. The<br>HEALIX ADVANCETM Anchor with PERMATAPETM Suture is provided sterile and<br>is for single use only. | |
| Technological<br>Characteristics | The proposed HEALIX ADVANCETM Anchors with PERMATAPETM Suture are<br>similar to the predicate HEALIX ADVANCETM Anchors with PERMACORDTM<br>Suture (K133794) in that they share the same intended use, anchor design and<br>materials, PERMACORD suture design and materials, device assembly, sterilization<br>method, and shelf life. The proposed devices are similar to the predicate Gryphon™<br>BR Anchor with Orthocord® Suture in that they share the same indications for use,<br>same anchor materials, similar anchor / device assembly design and principle of<br>operation. The proposed devices are similar to the reference device, PERMACORDTM<br>Suture (K162247), in that they share the same suture design and material. The<br>proposed devices are similar to the reference device, HEALIX ADVANCETM PEEK<br>Anchor (K120449), in that both are offered with or without needles to facilitate suture<br>passage through tissue. | |
| 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:<br>Foot/Ankle:<br>Knee:<br>Elbow:<br>Hip: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,<br>Capsular Shift or Capsulolabral Reconstruction<br>Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair<br>Medial Collateral Ligament Repair, Lateral Collateral Ligament<br>Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis<br>Biceps Tendon Reattachment, Ulnar Collateral Ligament<br>Reconstruction , Radial Collateral Ligament Reconstruction<br>Capsular Repair, Acetabular Labral Repair |
| Non clinical<br>Testing | Verification activities were performed on the proposed device and / or its predicates.<br>Testing assessments include pull out testing, insertion and failure torque and in-vitro<br>testing. | |
| Safety and<br>Performance | Results of performance testing have demonstrated that the proposed devices are<br>suitable for their intended use.<br><br>Bacterial endotoxin testing has been completed and results have demonstrated that the<br>proposed devices meet the endotoxin limits.<br><br>Based on similarities in the indications for use, technological characteristics, and<br>performance in comparison to the predicate devices, the proposed HEALIX<br>ADVANCETM Anchor with PERMATAPETM Suture has shown to be substantially | |

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