HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture

K203794 · Medos International SARL · MBI · Feb 1, 2021 · Orthopedic

Device Facts

• Record ID: K203794
• Device Name: HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture
• Applicant: Medos International SARL
• Product Code: MBI · Orthopedic
• Decision Date: Feb 1, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HEALIX Ti™ Dual Threaded Suture Anchor is intended for soft-tissue-to-bone fixation with postoperative immobilization. Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromioclavicular 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, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Device Story

HEALIX Ti Dual Threaded Suture Anchor is a non-absorbable titanium bone fixation fastener; line extension of existing HEALIX Ti anchor family. Device consists of threaded anchor preloaded on disposable inserter assembly; facilitates fixation of one strand of #2 DYNACORD suture and one strand of 2.5 mm DYNATAPE suture to bone. Used by orthopedic surgeons in clinical settings for soft-tissue-to-bone repair. Provides mechanical fixation of tendons/ligaments to bone; enables healing during postoperative immobilization. Single-use device; provided sterile.

Clinical Evidence

Bench testing only. Performance evaluation included fixation strength under cyclic loading, knot tensile strength, and suture approximation testing. Sterilization validated per ANSI/AAMI/ISO 11135:2014; EO residuals tested per AAMI/ANSI/ISO 10993-7:2008; non-pyrogenicity confirmed per ANSI/AAMI ST-72:2011, USP, and EP standards.

Technological Characteristics

Material: Titanium. Design: Non-absorbable dual threaded suture anchor. Form factor: Preloaded on disposable inserter assembly. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ANSI/AAMI/ISO 11135:2014, AAMI/ANSI/ISO 10993-7:2008, ANSI/AAMI ST-72:2011.

Indications for Use

Indicated for soft-tissue-to-bone fixation in patients requiring surgical repair of shoulder, foot/ankle, knee, or elbow ligaments and tendons, including rotator cuff, Bankart, biceps, acromioclavicular, deltoid, capsular, lateral/medial stabilization, Achilles, collateral ligaments, iliotibial band, and patellar tendon, with postoperative immobilization.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• HEALIX Ti™ ANCHORS with DYNACORD™ Suture (K183279)

Reference Devices

• HEALIX ADVANCE™ Anchor with DYNATAPE™ Suture (K200949)

Submission Summary (Full Text)

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February 1, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medos International SARL % Elizabeth Messana Regulatory Affairs Specialist II Depuy Synthes Mitek, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K203794

Trade/Device Name: HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 30, 2020 Received: January 4, 2020

Dear Elizabeth Messana:

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, 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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K203794

Device Name

HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture

Indications for Use (Describe)

The HEALIX Ti™ Dual Threaded Suture Anchor is intended for soft-tissue-to-bone fixation with postoperative immobilization.

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromioclavicular 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, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(K) SUMMARY HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture Date Prepared: 12/21/2020

| Submitter's Name and Address | DePuy Synthes Mitek Sports Medicine<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | On behalf of:<br>Medos International SARL<br>Chemin-Blanc 38, Le Locle Neuchatel<br>CH 2400, Switzerland |
| Contact Person | Elizabeth Messana<br>Regulatory Affairs Specialist II<br>DePuy Synthes Mitek Sports Medicine<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
| | Telephone: [phone]<br>Email: [e-mail] |
| Name of Medical Device | Trade Name / Proprietary Name:<br>HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture<br>Common Name:<br>Suture Anchor |

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| Substantial<br>Equivalence | The HEALIX TiTM Dual Threaded Suture Anchor with DYNATAPETM<br>Suture is substantially equivalent to the predicates:<br>K183279, HEALIX TiTM ANCHORS with DYNACORDTM<br>Suture (Primary Predicate) K200949, HEALIX ADVANCETM Anchor with<br>DYNATAPETM Suture (Reference Predicate) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Classification | HEALIX TiTM Dual Threaded Suture Anchor with DYNATAPETM Suture<br>is classified as:<br>Smooth or threaded metallic bone fixation fasteners, classified<br>as Class II, product code MBI, regulated under 21 CFR<br>888.3040. |
| Device Panel | Orthopedic Devices |
| Device<br>Description | The proposed HEALIX TiTM Dual Threaded Suture Anchor with<br>DYNATAPETM Suture is a line extension to the currently marketed<br>HEALIX TiTM Anchor family. The HEALIX Ti Anchor is a non-<br>absorbable dual threaded suture anchor comprised of Titanium material.<br>The threaded anchor comes preloaded on a disposable inserter assembly<br>and is intended for fixation of one strand of #2 DYNACORD Suture<br>and one strand of 2.5 mm DYNATAPE Suture to bone.<br>The HEALIX TiTM Dual Threaded Suture Anchor with DYNATAPETM<br>Suture is provided sterile via Ethylene Oxide (EO) sterilization and is<br>for single use only. |
| Technological<br>Characteristics | The suture anchor design and principal of operation are <b>identical</b> to the<br>predicate device HEALIX TiTM ANCHORS with DYNACORDTM<br>Suture (K183279), while the indications for use are <b>similar</b> to the<br>predicate as only a subset is pursued. |
| Indications for<br>Use | The HEALIX TiTM Dual Threaded Suture Anchor is intended for soft-<br>tissue-to-bone fixation in association with postoperative<br>immobilization.<br>Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair,<br>Biceps Tenodesis, Acromioclavicular Separation Repair, Deltoid<br>Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles<br>Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral<br>Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band<br>Tenodesis, Patellar Tendon repair and secondary fixation in<br>ACL/PCL reconstruction repair; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral<br>Ligament Reconstruction. |
| Non-clinical<br>Testing | Verification activities were performed on the proposed device and its<br>predicates. Performance testing included evaluation of fixation strength<br>following cyclic loading, knot tensile strength and suture approximation<br>testing.<br><br>Ethylene Oxide Sterilization was validated according to<br>ANSI/AAMI/ISO 11135: 2014 to a SAL of 1 x 10-6.<br><br>EO residuals were tested per AAMI/ANSI/ISO 10993-7:2008<br><br>The proposed device has been determined to be non-pyrogenic per the<br>requirements set forth in ANSI/AAMI ST-72:2011, United States<br>Pharmacopeia (USP), and European Pharmacopeia (EP) using the<br>bacterial endotoxin testing (BET) method. |
| Safety and<br>Performance | Results of performance testing have demonstrated that the proposed<br>devices are suitable for their intended use.<br><br>Based on similarities in the indications for use, technological<br>characteristics, and performance in comparison to the predicate devices,<br>the proposed HEALIX TiTM Dual Threaded Suture Anchor with<br>DYNATAPETM Suture has shown to be substantially equivalent to the<br>predicate devices under the Federal Food, Drug and Cosmetic Act. |

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