Who is the manufacturer of HEALIX ADVANCE SP BIOCOMPOSITE Anchor?

Medos International SARL filed the 510(k) submission for HEALIX ADVANCE SP BIOCOMPOSITE Anchor (K191242).

What is the FDA product code for HEALIX ADVANCE SP BIOCOMPOSITE Anchor?

MAI. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for HEALIX ADVANCE SP BIOCOMPOSITE Anchor?

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

What are the predicate devices for HEALIX ADVANCE SP BIOCOMPOSITE Anchor?

Arthrex PushLock Anchors (K101679); Arthrex PushLock Anchors (K082810); Arthrex PushLock Anchors (K071177); Arthrex PushLock Anchors (K061863); Arthrex PushLock Anchors (K051219).

Who can help prepare an FDA 510(k) submission like HEALIX ADVANCE SP BIOCOMPOSITE Anchor?

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 SP BIOCOMPOSITE Anchor

K191242 · Medos International SARL · MAI · Aug 22, 2019 · Orthopedic

Device Facts

Record ID	K191242
Device Name	HEALIX ADVANCE SP BIOCOMPOSITE Anchor
Applicant	Medos International SARL
Product Code	MAI · Orthopedic
Decision Date	Aug 22, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone: Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament reconstruction, iliotibial (IT) band tenodesis Foot/Ankle: Achilles tendon repair

Device Story

Two-piece self-punching suture anchor system; consists of cannulated threaded anchor and dilator; preloaded on disposable inserter shaft with handle. Anchor molded from absorbable Biocryl biocomposite (PLA and TCP); dilator made of non-absorbable PEEK. Held by UHMWPE and PET stay-suture. Used in orthopedic surgery for soft tissue reattachment to bone. Implanted permanently. Provides mechanical fixation of soft tissue to bone; facilitates healing. Sterile, single-use device.

Clinical Evidence

Bench testing only. Performance evaluation included in-vitro fixation strength at zero, six, and twelve weeks; insertion torque; torque to failure; and cyclic migration at time zero. Sterilization validated per ANSI/AAMI/ISO 11135:2014; EO residuals per AAMI/ANSI/ISO 10993-7:2008; non-pyrogenicity per ANSI/AAMI ST-72:2011.

Technological Characteristics

Two-piece cannulated threaded anchor (Biocryl PLA/TCP) and dilator (PEEK). UHMWPE/PET stay-suture. Sterile (Ethylene Oxide per ANSI/AAMI/ISO 11135:2014). Sizes: 4.9mm and 5.5mm. Mechanical fixation principle.

Indications for Use

Indicated for soft tissue-to-bone reattachment in shoulder (rotator cuff, biceps tenodesis, deltoid repair), knee (posterior oblique, MCL reconstruction, lateral ligament reconstruction, IT band tenodesis), and foot/ankle (Achilles tendon repair) procedures.

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

Arthrex PushLock Anchors (K101679)
Arthrex PushLock Anchors (K082810)
Arthrex PushLock Anchors (K071177)
Arthrex PushLock Anchors (K061863)
Arthrex PushLock Anchors (K051219)

Reference Devices

HEALIX ADVANCE™ SP PEEK Anchor (K182941)
Bio-INTRAFIX Tibial Tapered Screws and Sheaths (K032167)
SPEEDTRAP™ Graft Preparation System (K161638)

Related Devices

K201883 — 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor · Medos International SARL · Aug 7, 2020
K173859 — HEALIX ADVANCE Anchor with DYNACORD Suture · Medos International SARL · Apr 11, 2018
K023192 — STRYKER BIOZIP SUTURE ANCHOR · Stryker Endoscopy · Mar 20, 2003
K182941 — HEALIX ADVANCE SP PEEK Anchor · Medos International SARL · Feb 26, 2019
K241010 — HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors · Depuy Mitek · Sep 11, 2024

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). 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 image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. Medos International SARL % Elizabeth Messana Regulatory Affairs Specialist II DePuy Synthes Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767 Re: K191242 Trade/Device Name: HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: July 11, 2019 Received: July 15, 2019 Dear Ms. 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 {1}------------------------------------------------ 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 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 (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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K191242 Device Name HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor Indications for Use (Describe) The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone: · Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair · Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament reconstruction, iliotibial (IT) band tenodesis · Foot/Ankle: Achilles tendon 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™ SP BIOCOMPOSITE Anchor Date Prepared: 05/7/2019 | 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 | Elizabeth Messana Regulatory Affairs Specialist II DePuy Synthes Mitek Sports Medicine a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 | Telephone: 508-828-3150 Email: emessan1@its.jnj.com | | Name of Medical Device | Proprietary Name: HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor Classification Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: MAI Common Name: Suture Anchor | | | Substantial Equivalence | The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is substantially equivalent to: K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Reference Devices: K182941, HEALIX ADVANCE™ SP PEEK Anchor K032167, Bio-INTRAFIX Tibial Tapered Screws and Sheaths K161638, SPEEDTRAP™ Graft Preparation System | | | Device Classification | HEALIX ADVANCE SP BIOCOMPOSITE Anchor 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. | | | Device Panel | Orthopedic Devices | | | Device Description | The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is a two-piece "self-punching" design consisting of a cannulated, threaded anchor and dilator which are permanently implanted into the body. The anchor- dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). The proposed HEALIX ADVANCE SP BIOCOMPOSITE Anchor is offered in two sizes, 4.9 mm and 5.5 mm and is molded from Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material. The dilator is comprised of Non-absorbable PEEK (Polyetheretherketone). The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only. | | | Technological Characteristics | The suture anchor design, anchor materials, principal of operation and indications for use are similar when compared to the predicate Arthrex PushLock Anchors (K101679, K082810, K071177, K061863, K051219). | | | | The suture anchor design, principal of operation and indications for use are identical when compared to the reference device- HEALIX ADVANCE™ SP PEEK Anchor (K182941) | | | | The Biocryl (PLA/ ß-TCP) Biocomposite material of the anchor is identical to the Biocryl in the reference device- Bio-INTRAFIX Tibial Tapered Screws and Sheaths (K032167). | | | | The PEEK (Polyetheretherketone) design and material of the dilator component is identical to the PEEK dilator in the reference device- HEALIX ADVANCE™ SP PEEK Anchor (K182941). | | | | The stay-suture material (UHMWPE/PET) is identical to the winding suture present in the reference device- SPEEDTRAPTM Graft Preparation System (K161638). | | | Indications for Use | The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is indicated for use in the following procedures for reattachment of soft tissue to bone: • Shoulder: Rotator cuff repair, biceps tenodesis, deltoid repair • Knee: Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral collateral ligament reconstruction, iliotibial (IT) band tenodesis • Foot/Ankle: Achilles tendon repair | | | Non-clinical Testing | Verification activities were performed on the proposed device and / or its predicates. Performance testing included evaluation of in-vitro fixation strength at zero, six and twelve weeks, insertion torque, torque to failure and cyclic migration at time zero. Ethylene Oxide Sterilization was validated according to ANSI/AAMI/ISO 11135: 2014 to a SAL of 1 x 10-6. EO residuals were tested per AAMI/ANSI/ISO 10993-7:2008 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 Performance | Results of performance testing have demonstrated that the proposed devices are 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 SP BIOCOMPOSITE Anchor has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act. | | {4}------------------------------------------------ {5}------------------------------------------------