HEALIX ADVANCE Anchor with DYNACORD Suture

K173859 · Medos International SARL · MAI · Apr 11, 2018 · Orthopedic

Device Facts

• Record ID: K173859
• Device Name: HEALIX ADVANCE Anchor with DYNACORD Suture
• Applicant: Medos International SARL
• Product Code: MAI · Orthopedic
• Decision Date: Apr 11, 2018
• 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 assembly; used for soft tissue-to-bone fixation. Available in absorbable BR or non-absorbable PEEK materials; includes optional needles for suture passage. Operated by surgeons in clinical/OR settings. Device provides mechanical fixation of soft tissue to bone; facilitates healing during post-operative immobilization. Single-use, sterile device.

Clinical Evidence

Bench testing only. Performance testing included anchor fixation, in-vitro testing, torque testing, suture testing per USP, suture approximation force, and in-vivo testing. Safety evaluations addressed biological, sterility, packaging, shelf-life, and bacterial endotoxin limits.

Technological Characteristics

Threaded suture anchor; materials: absorbable BR or non-absorbable PEEK. Suture: non-absorbable DYNACORD (conforms to USP except diameter). Single-use, sterile, disposable inserter assembly. Mechanical fixation principle.

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 orthopedic repairs such as rotator cuff, ligament, or tendon reconstruction.

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)

Reference Devices

• HEALIX ADVANCE Anchors with ORTHOCORD Suture (K120078/K120449)
• FiberWire (Arthrex) (K021434, K041553)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

April 11. 2018

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

Re: K173859

Trade/Device Name: HEALIX ADVANCE™ 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: March 14, 2018 Received: March 15, 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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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# Page 2 - Tatyana Korsunsky

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

# 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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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) K173859

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.

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# SECTION 2 - 510(k) SUMMARY

# HEALIX ADVANCE™ Anchor with DYNACORD™ Suture

## Date Prepared: December 18, 2017

| 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 DYNACORD™ Suture<br>b) HEALIX ADVANCE™ PEEK Anchor with DYNACORD™ Suture | | |
| | Classification Name: a) Single/multiple component metallic bone fixation appliances and accessories<br>b) Smooth or threaded metallic bone fixation fasteners | | |
| | Common Name: Suture Anchor | | |
| Substantial<br>Equivalence | The HEALIX ADVANCE™ Anchor with DYNACORD™ Suture is substantially<br>equivalent to:<br>• K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture<br><br>Reference devices:<br>• K120078/K120449 HEALIX ADVANCE™ Anchors with ORTHOCORD® Suture<br>• K021434, K041553 FiberWire® (Arthrex) | | |
| 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><br>> HEALIX ADVANCE™ PEEK Anchor with DYNACORD™ Suture is classified as:<br>Smooth or threaded metallic bone fixation fasteners, classified as Class II,<br>product code MBI, regulated under 21 CFR 888.3040. | | |

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| Device<br>Description | The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threaded<br>suture anchor preloaded on a disposable inserter assembly intended for fixation of<br>soft tissue to bone. HEALIX ADVANCETM Anchors with DYNACORDTM Suture<br>are available in absorbable BR and non-absorbable PEEK materials. Devices with<br>needles will be offered to facilitate suture passage through tissue. The HEALIX<br>ADVANCETM Anchor with DYNACORDTM Suture is provided sterile and is for<br>single use only. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The proposed HEALIX ADVANCETM Anchor with DYNACORDTM Suture has the<br>same anchor materials, design, principle of operation, as well as device assembly,<br>sterilization method, and shelf life, as predicate HEALIX ADVANCETM Anchor<br>with PERMACORDTM Suture (K133794). The DYNACORDTM Suture component<br>is a non-absorbable suture that conforms to USP, except for oversized diameter. |
| 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<br><b>Hip:</b> Capsular Repair, Acetabular Labral Repair |
| Non clinical<br>Testing | Non-clinical testing has been performed on the proposed device and / or its<br>predicates. Performance testing included anchor fixation testing, <i>in-vitro</i> testing,<br>torque testing, suture testing per USP, suture approximation force testing, <i>in-vivo</i><br>testing. Safety evaluations were conducted to address biological, sterility,<br>packaging, shelf-life and included <i>in-vivo</i> testing. Bacterial endotoxin testing has<br>been completed and results have demonstrated that the proposed devices meet the<br>endotoxin limits. |
| 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,<br>technological characteristics, and performance in comparison to the predicate<br>devices, the proposed HEALIX ADVANCETM Anchor with DYNACORDTM Suture<br>has shown to be substantially equivalent to the predicate devices under the Federal<br>Food, Drug and Cosmetic Act. |