Who is the manufacturer of HEALIX ADVANCE Anchor with DYNA+TAPE Sutures?

Medos International SARL filed the 510(k) submission for HEALIX ADVANCE Anchor with DYNA+TAPE Sutures (K191483).

What is the FDA product code for HEALIX ADVANCE Anchor with DYNA+TAPE Sutures?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for HEALIX ADVANCE Anchor with DYNA+TAPE Sutures?

510(k) clearance (submission type: Special).

What are the predicate devices for HEALIX ADVANCE Anchor with DYNA+TAPE Sutures?

HEALIX ADVANCE Anchor with PERMATAPE™ Suture (K170639); HEALIX ADVANCE Anchor with DYNACORD™ Suture (K173859).

Who can help prepare an FDA 510(k) submission like HEALIX ADVANCE Anchor with DYNA+TAPE Sutures?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HEALIX ADVANCE Anchor with DYNA+TAPE Sutures

K191483 · Medos International SARL · MBI · Jun 28, 2019 · Orthopedic

Device Facts

Record ID	K191483
Device Name	HEALIX ADVANCE Anchor with DYNA+TAPE Sutures
Applicant	Medos International SARL
Product Code	MBI · Orthopedic
Decision Date	Jun 28, 2019
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows: Shoulder: Rotator Cuff Repair, Bankart 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; used for soft tissue-to-bone fixation. Device combines one strand of #2 DYNACORD suture and one strand of PERMATAPE suture. Used by surgeons in clinical settings (OR) for orthopedic repairs including rotator cuff, ligament, and tendon reattachments. Provides mechanical fixation to bone; facilitates healing through immobilization. Benefits patient by securing soft tissue to bone during recovery.

Clinical Evidence

Bench testing only. Performance testing evaluated fixation strength following cyclic loading. Device confirmed non-pyrogenic per ANSI/AAMI ST-72:2011, USP, and EP standards.

Technological Characteristics

Materials: Biocryl Rapide (BR) or PEEK. Form factor: Threaded suture anchor with disposable inserter. Sterilization: Sterile, single-use. Non-pyrogenic per ANSI/AAMI ST-72:2011.

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

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 ADVANCE Anchor with PERMATAPE™ Suture (K170639)
HEALIX ADVANCE Anchor with DYNACORD™ Suture (K173859)

Related Devices

K170639 — HEALIX ADVANCE Anchor with PERMATAPE Suture · Medos International SARL · May 18, 2017
K133794 — 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 · Depuy Mitek, A Johnson & Johnson Company · Feb 4, 2014
K983818 — MITEK FASTIN RC ANCHOR · Mitek Products · Nov 23, 1998
K242895 — Aevumed PHANTOM Suture Anchors · Aevumed, Inc. · Aug 6, 2025
K071257 — MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD · Depuy Mitek, A Johnson & Johnson Company · Jun 29, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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 - USA logo. To the right of that is the FDA logo, which 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 % Ashley Goncalo Project Manager - Regulatory Affairs DePuy Synthes Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767 Re: K191483 Trade/Device Name: HEALIX ADVANCE™ Anchor with DYNA+TAPE™ Sutures Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, MAI Dated: June 3, 2019 Received: June 4, 2019 Dear Ashley Goncalo: 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. {1}------------------------------------------------ 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) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Laurence D. Coyne, 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 {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K191483 Device Name HEALIX ADVANCE™ Anchor with DYNA+TAPE™ Sutures ### Indications for Use (Describe) The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows: Shoulder: Rotator Cuff Repair, Bankart 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 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) #### 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}------------------------------------------------ # 510(K) SUMMARY ## HEALIX ADVANCE™ Anchor with DYNA+TAPE™ Sutures | Submitter's Name and Address | DePuy Synthes Mitek Sports Medicine a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 On behalf of: Medos International SARL Chemin-Blanc 38, Le Locle Neuchatel CH 2400, Switzerland | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Ashley Goncalo Project Manager, Regulatory Affairs DePuy Synthes Mitek Sports Medicine a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 Telephone: 508-977-3907 Email: agoncalo@its.jnj.com | | Name of Medical Device | Proprietary Name: HEALIX ADVANCE Anchor with DYNA+TAPE Sutures a) HEALIX ADVANCE BR Anchor with DYNA+TAPE Sutures b) HEALIX ADVANCE PEEK Anchor with DYNA+TAPE Sutures Classification Name: a) Single/multiple component metallic bone fixation appliances and accessories b) Smooth or threaded metallic bone fixation fasteners Common Name: Suture Anchor | | Substantial Equivalence | The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is substantially equivalent to the predicates: • K170639 - HEALIX ADVANCE Anchor with PERMATAPE™ Suture (Primary) • K173859 - HEALIX ADVANCE Anchor with DYNACORD™ Suture | | Device Classification | a) HEALIX ADVANCE BR Anchor with DYNA+TAPE Sutures is classified as: Single/multiple component metallic bone fixation appliances and accessories, classified as Class II, product code MAI, regulated under 21 CFR 888.3030. | | | b) HEALIX ADVANCE PEEK Anchor with DYNA+TAPE Sutures is classified as: Smooth or threaded metallic bone fixation fasteners, classified as Class II, product code MBI, regulated under 21 CFR 888.3040. | | Device Description | The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is a threaded suture anchor preloaded on a disposable inserter assembly intended for soft tissue fixation with one strand of #2 DYNACORD Suture and one strand of PERMATAPE Suture to bone. HEALIX ADVANCE with DYNA+TAPE Anchors are available in absorbable Biocryl Rapide® (BR) and non-absorbable PEEK materials. The HEALIX ADVANCE with DYNA+TAPE Sutures is provided sterile and is for single use only. | | Technological Characteristics | The proposed HEALIX ADVANCE Anchor with DYNA+TAPE Sutures has the same anchor materials, design, principle of operation, intended use, sterilization method, and shelf life, as the predicate HEALIX ADVANCE with DYNACORD Anchors (K173859) and the predicate HEALIX ADVANCE with PERMATAPE Anchors (K170639). The PERMATAPE Suture, which is preloaded on the proposed anchor, is identical to the PERMATAPE Suture which is preloaded on the predicate HEALIX ADVANCE with PERMATAPE Suture (K170639). The DYNACORD Suture, which is preloaded on the proposed anchor, is identical to the suture that is pre-loaded on the predicate HEALIX ADVANCE with DYNACORD Suture (K173859). | | Indications for Use | The HEALIX ADVANCE Anchor with DYNA+TAPE Sutures is indicated for use in soft tissue to bone fixation in association 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 | | Non-clinical Testing | Verification activities were performed on the proposed device and / or its predicates. Performance testing included evaluation of fixation strength following cyclic loading. | {4}------------------------------------------------ {5}------------------------------------------------ The proposed device has been determined to be non-pyrogenic per the requirements set forth in ANSI/AAMI ST-72:2011, United States Pharmacopeia (USP), and European Pharmacopeia (EP) using the bacterial endotoxin testing (BET) method. #### Safety and Results of performance testing have demonstrated that the proposed devices are Performance suitable for their intended use. Based on similarities in the indications for use, technological characteristics, and performance in comparison to the predicate devices, the proposed HEALIX ADVANCE with DYNA+TAPE Anchors has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.