HEALIX ADVANCE Anchor with DYNACORD Suture

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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); {1}------------------------------------------------ # 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {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) 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. 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 ## 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: 508-828-3122<br>e-mail: tkorsuns@its.jnj.com | | | | 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. | | | {4}------------------------------------------------ | 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. |