What is the regulatory pathway for 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor?

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

What are the predicate devices for 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor?

HEALIX ADVANCE SP PEEK Anchor (K182941); HEALIX ADVANCE SP BIOCOMPOSITE Anchor (K191242).

Who can help prepare an FDA 510(k) submission like 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm 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.

6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor

Q: Who is the manufacturer of 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor?

Medos International SARL filed the 510(k) submission for 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor (K201883).

Q: What is the FDA product code for 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor?

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

K201883 · Medos International SARL · MBI · Aug 7, 2020 · Orthopedic

Device Facts

Record ID	K201883
Device Name	6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor
Applicant	Medos International SARL
Product Code	MBI · Orthopedic
Decision Date	Aug 7, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The HEALIX ADVANCE SP PEEK Anchor is 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 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 - Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament Knee: reconstruction, iliotibial (IT) band tenodesis - Foot/Ankle: Achilles tendon repair (4.9mm & 5.5mm only)

Device Story

Two-piece self-punching suture anchor system; consists of cannulated threaded anchor (PEEK or Biocomposite) and PEEK dilator; preloaded on disposable inserter shaft with handle; held by non-absorbable UHMWPE/PET stay suture. Implanted into bone by surgeon during orthopedic procedures; stay suture discarded after implantation. Provides mechanical fixation for soft tissue reattachment. Benefits patient by securing soft tissue to bone to facilitate healing. Sterile, single-use device.

Clinical Evidence

Bench testing only. Evaluated in-vitro fixation strength at 0, 6, and 12 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

Materials: PEEK or Biocomposite (PLA and Tricalcium Phosphate). Design: Cannulated, threaded, two-piece self-punching anchor with PEEK dilator. Dimensions: 6.5 mm size. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Single-use. No software or electronics.

Indications for Use

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

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 SP PEEK Anchor (K182941)
HEALIX ADVANCE SP BIOCOMPOSITE Anchor (K191242)

Related Devices

K191242 — HEALIX ADVANCE SP BIOCOMPOSITE Anchor · Medos International SARL · Aug 22, 2019
K260004 — Aevumed PROTEKT Suture Anchor · Aevumed, Inc. · Jan 28, 2026
K160996 — Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm · Dunamis, LLC · Jul 6, 2016
K070882 — STRYKER PEEK TWINLOOP TAC · Stryker Endoscopy · Jul 20, 2007
K211502 — Alpha Vent PEEK Suture Anchor · Stryker Endoscopy · Aug 4, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ August 7, 2020 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol representing the Department of Health & Human Services-USA on the left, and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in a sans-serif font, with "FDA" in a blue square and the rest of the text in blue as well. Medos International SARL % Elizabeth Messana Regulatory Affairs Specialist II DePuy Synthes Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767 Re: K201883 Trade/Device Name: 6.5 mm HEALIX ADVANCE™ SP PEEK Anchor, 6.5 mm HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, MAI Dated: July 7, 2020 Received: July 8, 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 {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, for Laura C. Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K201883 Device Name HEALIX ADVANCE™ SP PEEK Anchor HEALIX ADVANCE™ SP Biocomposite Anchor Indications for Use (Describe) The HEALIX ADVANCE SP PEEK Anchor is 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 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 - Posterior oblique repair, medial collateral ligament (MCL) reconstruction, lateral ligament Knee: reconstruction, iliotibial (IT) band tenodesis - Foot/Ankle: Achilles tendon repair (4.9mm & 5.5mm only) 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 Anchor Date Prepared: 07/02/2020 | 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 | Substantial Equivalence | The HEALIX ADVANCE SP PEEK Anchor is substantially equivalent to: • K182941, HEALIX ADVANCE SP PEEK Anchor The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is substantially equivalent to: • K191242, HEALIX ADVANCE SP BIOCOMPOSITE Anchor | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Elizabeth Messana Regulatory Affairs Specialist II Telephone: 508-828-3150 Email: emessan1@its.jnj.com DePuy Synthes Mitek Sports Medicine a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 | Device Classification | HEALIX ADVANCE SP PEEK Anchor is classified as: Fastener, Fixation, Nondegradable, Soft Tissue, classified as Class II, product code MBI, regulated under 21 CFR 888.3040. 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. | | Name of Medical Device | Proprietary Name: A) HEALIX ADVANCE™ SP PEEK Anchor B) HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor Classification Name: A) Smooth or threaded metallic bone fixation fastener B) Single/multiple component metallic bone fixation appliances and accessories Product Code: A) MBI B) MAI Common Name: Suture Anchor | Device Panel | Orthopedic Devices | | Device Description | The proposed HEALIX ADVANCE SP PEEK and BIOCOMPOSITE Anchors is a line extension to the currently marketed HEALIX ADVANCE SP Anchor family. Both versions of the device consist of a two-piece "self-punching" design consisting of a cannulated, threaded anchor (PEEK or BIOCOMPOSITE) and PEEK (Polyetheretherketone) 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). Following anchor-dilator implantation, the stay suture is discarded. The proposed HEALIX ADVANCE SP PEEK and BIOCOMPOSITE Anchors will be available in a new size option, 6.5 mm, molded from either Polyetheretherketone (PEEK) material or Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material. Both the HEALIX ADVANCE SP PEEK Anchor and HEALIX ADVANCE SP BIOCOMPOSITE Anchor are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only. | | | {4}------------------------------------------------ {5}------------------------------------------------ | Technological Characteristics | The suture anchor design, principal of operation and indications for use are identical when compared to the predicate device- HEALIX ADVANCE™ SP PEEK Anchor (K182941). The suture anchor design and principal of operation are identical when compared to the predicate device- HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor (K191242), and similar in terms of indications for use (a subset is pursued). | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The HEALIX ADVANCE SP PEEK 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 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 (4.9mm & 5.5mm only) | | Non-clinical Testing | Verification activities were performed on the proposed device and 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 PEEK Anchor and HEALIX ADVANCE SP BIOCOMPOSITE Anchor has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act. | {6}------------------------------------------------