HEALIX Ti ANCHOR with DYNACORD

K183279 · Medos International SARL · MBI · Feb 21, 2019 · Orthopedic

Device Facts

• Record ID: K183279
• Device Name: HEALIX Ti ANCHOR with DYNACORD
• Applicant: Medos International SARL
• Product Code: MBI · Orthopedic
• Decision Date: Feb 21, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HEALIX TiTM Anchors with DYNACORD™ is intended for: 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; Hip: Capsular repair, Acetabular Labral Repair.

Device Story

Threaded titanium suture anchor preloaded on disposable inserter; used for soft tissue-to-bone fixation. Operated by surgeons in clinical settings. Device provides mechanical fixation of tendons/ligaments to bone; facilitates tissue repair. Benefits include secure attachment of soft tissue to bone to support healing. Provided sterile for single use.

Clinical Evidence

Bench testing only. Performance testing included anchor fixation, torque, and suture testing per USP. Safety evaluations covered biological, sterility, packaging, and shelf-life. Bacterial endotoxin testing confirmed compliance with limits.

Technological Characteristics

Titanium anchor; threaded design; non-absorbable DYNACORD suture (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. Includes rotator cuff, Bankart, SLAP lesion, biceps tenodesis, AC separation, deltoid, capsular, labral, ligament, and tendon repairs.

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® Anchor with ORTHOCORD® (K082282)

Reference Devices

• HEALIX ADVANCE® Anchors with DYNACORD® Suture (K173859)
• FIBERWIRE® (Arthrex) (K021434, K041553)
• GRYPHON ANCHOR® with DYNACORD® (K181809)
• DYNACORD® (K082282)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.

February 21, 2019

Medos International SARL % Leslie Coney Regulatory Affairs Specialist DePuy Mitek, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K183279

Trade/Device Name: HEALIX TiTM ANCHOR with DYNACORD™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: November 19, 2018 Received: November 23, 2018

Dear Leslie Coney:

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

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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) 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 (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-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

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# Indications for Use

510(k) Number (if known) K183279

Device Name HEALIX Ti™ ANCHOR with DYNACORD™

Indications for Use (Describe) The HEALIX TiTM Anchors with DYNACORD™ is intended for:

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;

Hip: Capsular repair, Acetabular Labral Repair.

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

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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## 510(k) SUMMARY

### HEALIX Ti™ Anchor with DYNACORD™ Suture

### Date Prepared: January 23, 2019

| Submitter's<br>Name and<br>Address | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Leslie Coney<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>e-mail: [e-mail] |
| Name of<br>Medical Device | Proprietary Name:<br>-HEALIX TI™ ANCHOR with DYNACORD™<br>-HEALIX TI™ 3 SUTURE ANCHOR with<br>DYNACORD™<br>-HEALIX TI™ ANCHOR with DYNACORD™ AND<br>NEEDLES<br><br>Classification Name: Smooth or threaded metallic bone fixation fasteners<br><br>Common Name: Suture Anchor |
| Substantial<br>Equivalence | The HEALIX Ti™ Anchor with DYNACORD™ Suture is substantially equivalent<br>to:<br>K082282 HEALIX Ti® Anchor with ORTHOCORD®<br>Reference devices:<br>K173859 HEALIX ADVANCE® Anchors with DYNACORD® SutureK021434, K041553 FIBERWIRE® (Arthrex)K181809 GRYPHON ANCHOR® with DYNACORD®K082282 DYNACORD® |
| Device<br>Classification | > HEALIX Ti™ Anchor with DYNACORD™ Suture is classified as:<br>Single/multiple component metallic bone fixation appliances and accessories,<br>classified as Class II, product code MBI, regulated under 21 CFR 888.3040.<br>Single/multiple component metallic bone fixation appliances and accessories, |
| Device<br>Description | The HEALIX TiTM Anchor with DYNACORDTM Suture is a threaded suture anchor<br>preloaded on a disposable inserter assembly intended for fixation of soft tissue to<br>bone. HEALIX TiTM Anchors with DYNACORDTM Suture is available in Titanium<br>material, which is a common material used on existing Depuy Mitek devices.<br>Devices with needles will be offered to facilitate suture passage through tissue. The<br>HEALIX TiTM Anchor with DYNACORDTM Suture is provided sterile and is for<br>single use only. |
| Technological<br>Characteristics | The proposed HEALIX TiTM Anchor with DYNACORDTM Suture has the same<br>anchor materials, design, principle of operation, as well as device assembly,<br>sterilization method, and shelf life, as predicate HEALIX TiTM Anchor with<br>ORTHOCORD® Suture (K082282). The DYNACORD® Suture component is a<br>non-absorbable suture that conforms to USP, except for oversized diameter. |
| Indications for<br>Use | The HEALIX TiTM Anchors with DYNACORDTM is intended for:<br>Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or<br>Capsulolabral Reconstruction;<br>Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;<br>Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,<br>Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patella tendon repair<br>and secondary fixation in ACL / PCL reconstruction repair.<br>Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament<br>Reconstruction.<br>Hip: Capsular repair, acetabular labral repair |
| Non clinical<br>Testing<br>Safety and<br>Performance | Non-clinical testing has been performed on the proposed device and /or its<br>predicates. Performance testing included anchor fixation testing, torque testing,<br>suture testing per USP and approximation force testing. Safety evaluations were<br>conducted to address biological, sterility, packaging and shelf-life testing. Bacterial<br>endotoxin testing has been completed and results have demonstrated that the<br>proposed devices meet the endotoxin limits.<br>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 TiTM Anchor with DYNACORDTM Suture has<br>shown to be substantially equivalent to the predicate devices under the Federal<br>Food, Drug and Cosmetic Act. |

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