HEALIX ADVANCE Anchor with DYNACORD Suture

K183506 · Medos International SARL · MAI · Feb 14, 2019 · Orthopedic

Device Facts

• Record ID: K183506
• Device Name: HEALIX ADVANCE Anchor with DYNACORD Suture
• Applicant: Medos International SARL
• Product Code: MAI · Orthopedic
• Decision Date: Feb 14, 2019
• 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; available in absorbable BR or non-absorbable PEEK materials. DYNACORD suture features silicone core with salt particles; in aqueous environment, salt elutes, creating micro-porous structure; core hydrates and expands radially, causing axial shortening to resist laxity and maintain compression. Used by surgeons in orthopedic procedures (shoulder, knee, hip, etc.) to reattach soft tissue to bone. Provides mechanical fixation; helps maintain approximation force during healing. Sterile, single-use device.

Clinical Evidence

Bench testing only. Testing included suture diameter, knot tensile strength, suture approximation force, and chemical characterization. Anchor fixation, torque testing, in-vivo testing, biocompatibility, sterility, packaging, shelf-life, and bacterial endotoxin testing were leveraged from predicate K173859.

Technological Characteristics

Threaded suture anchor; materials: absorbable BR or non-absorbable PEEK. Suture: silicone core with salt particles for radial expansion/axial shortening mechanism. Sterile, single-use, disposable inserter assembly. 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.

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 DYNACORD Suture (K173859)

Reference Devices

• FiberWire (Arthrex) (K021434)
• FiberWire (Arthrex) (K041553)
• HEALIX ADVANCE Anchors with PERMACORD Suture (K133794)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

February 14, 2019

Medos International SARL % Tatyana Korsunsky Regulatory Affairs Project Manager DePuy Mitek, a Johnson and Johnson company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K183506

Trade/Device Name: HEALIX ADVANCETM Anchor with DYNACORD™ 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: December 17, 2018 Received: December 18, 2018

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Laurence D. Coyne -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

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

### Indications for Use

510(k) Number (if known) K183506

Device Name

HEALIX ADVANCETM Anchor with DYNACORD™ 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<br>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<br>Repair, Iliotibial Band Tenodesis |
| Elbow: | Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament<br>Reconstruction |
| Hip: | Capsular Repair, Acetabular Labral Repair |

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

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# SECTION 2 - 510(k) SUMMARY

## HEALIX ADVANCE™ Anchor with DYNACORD™ Suture

| Submitter's<br>Name and<br>Address | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tatyana Korsunsky<br>Regulatory Affairs Project Manager<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br>Telephone: [phone]<br>e-mail: [e-mail] |
| Name of<br>Medical Device | Proprietary Name: a) HEALIX ADVANCE™ BR Anchor with<br>DYNACORD™ Suture<br>b) HEALIX ADVANCE™ PEEK Anchor with<br>DYNACORD™ Suture<br>Classification Name: a) Single/multiple component metallic bone fixation<br>appliances and accessories<br>b) Smooth or threaded metallic bone fixation fasteners<br>Common Name: Suture Anchor |
| Substantial<br>Equivalence | The HEALIX ADVANCE™ Anchor with DYNACORD™ Suture is substantially<br>equivalent to:<br>K173859 HEALIX ADVANCE™ Anchor with DYNACORD™ Suture<br>Reference devices:<br>K021434, K041553 FiberWire® (Arthrex)<br>K133794 HEALIX ADVANCE™ Anchors with PERMACORD™ Suture |
| Device<br>Classification | HEALIX ADVANCE™ BR Anchor with DYNACORD™ 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 DYNACORD™ Suture is classified<br>as:<br>Smooth or threaded metallic bone fixation fasteners, classified as Class II,<br>product code MBI, regulated under 21 CFR 888.3040. |
| Device<br>Description | The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threaded<br>suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCETM<br>Anchors with DYNACORDTM Suture are available in absorbable BR and non-<br>absorbable PEEK materials. Devices with needles will be offered to facilitate suture<br>passage through tissue. The HEALIX ADVANCETM Anchor with DYNACORDTM<br>Suture is provided sterile and is for single use only. |
| Technological<br>Characteristics | The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is intended for<br>fixation of soft tissue to bone, where anchor is inserted into the bone and sutures are<br>utilized to hold soft tissue. |
| | When DYNACORD™ Suture is placed in an aqueous environment, the salt particles<br>within the silicone core elute out, leaving behind a micro-porous structure within the<br>silicone core. These small voids are consequently filled with surrounding fluid as the<br>core hydrates, resulting in a radial expansion of the suture. If laxity is present, this<br>radial expansion of the braid causes an axial shortening of the total suture length.<br>The DYNACORD™ Suture is designed to resist laxity and minimize gap formation,<br>by maintaining approximation force (compression). |
| Comparison to<br>the Predicate<br>Devices | The proposed HEALIX ADVANCETM Anchor with DYNACORD™ Suture is an<br>update to the predicate HEALIX ADVANCETM Anchor with DYNACORDTM<br>Suture (K173859). The outer sheath of white/black DYNACORD is updated with<br>black UHMWPE, and removal of black Nylon. |
| Indications for<br>Use | The HEALIX ADVANCETM Anchor is indicated for use in soft tissue to bone<br>fixation in association with post-operative immobilization as follows: |
| | <b>Shoulder:</b> Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,<br>Capsular Shift or Capsulolabral Reconstruction |
| | <b>Foot/Ankle:</b> Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair<br><b>Knee:</b> Medial Collateral Ligament Repair, Lateral Collateral Ligament<br>Repair, Posterior Oblique Ligament Repair, Iliotibial Band<br>Tenodesis |
| | <b>Elbow:</b> Biceps Tendon Reattachment, Ulnar Collateral Ligament<br>Reconstruction , Radial Collateral Ligament Reconstruction |
| | <b>Hip:</b> Capsular Repair, Acetabular Labral Repair |
| Non clinical<br>Testing | Device safety and effectiveness is supported by non-clinical testing on the proposed<br>device and / or its predicate. Testing included suture diameter, knot tensile, suture<br>approximation force and chemical characterization. Anchor fixation, <i>in-vitro</i><br>anchor fixation, torque testing, <i>in-vivo</i> testing, biocompatibility, sterility,<br>packaging, shelf-life, and bacterial endotoxin testing of the predicate device were<br>included by reference (K173859). |
| Safety and<br>Performance | Results of performed testing have demonstrated that the proposed device is suitable<br>for its intended use. Based on the similarities in the indications for use,<br>technological characteristics, and performance in comparison to the predicate<br>devices, the proposed HEALIX ADVANCE™ Anchor with DYNACORD™ Suture<br>has shown to be substantially equivalent to the predicate devices under the Federal<br>Food, Drug and Cosmetic Act. |

{4}------------------------------------------------

{5}------------------------------------------------