Who is the manufacturer of DYNATAPE Suture?

Medos International SARL filed the 510(k) submission for DYNATAPE Suture (K203186).

What is the FDA product code for DYNATAPE Suture?

GAT. It is classified under 21 CFR 878.5000 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for DYNATAPE Suture?

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

Who can help prepare an FDA 510(k) submission like DYNATAPE Suture?

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.

DYNATAPE Suture

K203186 · Medos International SARL · GAT · Mar 18, 2021 · General, Plastic Surgery

Device Facts

Record ID	K203186
Device Name	DYNATAPE Suture
Applicant	Medos International SARL
Product Code	GAT · General, Plastic Surgery
Decision Date	Mar 18, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.5000
Device Class	Class 2
Attributes	Therapeutic

Intended Use

DYNATAPE suture is indicated for orthopedic procedural use in soft-tissue approximation, and or ligation, including use with allograft tissue.

Device Story

DYNATAPE Suture is a sterile, non-absorbable orthopedic suture featuring a double sheath and core design. It is composed of Ultra High Molecular Weight Polyethylene (UHMWPE) and Polyester, with a Silicone/NaCl core. The outer sheath is braided flat to increase tissue contact area. When placed in an aqueous environment, salt particles in the silicone core elute, creating a micro-porous structure that hydrates and expands radially. This radial expansion causes axial shortening of the suture, providing a self-tensioning property designed to resist laxity and minimize gap formation in soft-tissue repairs. The device is used by surgeons in orthopedic procedures. It functions as a mechanical fixation aid to maintain approximation force on tissue. Benefits include improved maintenance of tissue approximation and reduced risk of repair laxity.

Clinical Evidence

Bench testing only. Testing included USP knot tensile strength, in-vitro approximation force over time, and sterility testing. Biocompatibility, stability, and in-vivo testing were leveraged from the predicate device (K181182). Bacterial endotoxin testing was completed as part of K200949.

Technological Characteristics

Materials: Ultra High Molecular Weight Polyethylene (UHMWPE), Polyester, Silicone, NaCl. Design: Double sheath and core; flat braided outer sheath. Dimensions: Meets USP knot tensile strength for size 2; does not follow USP diameter requirements due to flat geometry. Principle: Self-tensioning via radial expansion of hydrated silicone core. Sterilization: Sterile.

Indications for Use

Indicated for orthopedic soft-tissue approximation and/or ligation, including use with allograft tissue.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

DYNACORD Suture (K181182)

Reference Devices

HEALIX ADVANCE Anchor with DYNATAPE Suture (K200949)
HEALIX ADVANCE Anchor with DYNACORD Suture (K183506)
FiberWire (K021434)
FiberWire (K041553)

Related Devices

K181182 — DYNACORD Suture · Medos International SARL · Aug 2, 2018
K171296 — SutureTape · Arthrex, Inc. · May 26, 2017
K172016 — Force Fiber Fusion Suture · Teleflex Medical Incorporated · Oct 3, 2017
K150584 — Stryker Suture Tape · Stryker · Aug 13, 2015
K200949 — HEALIX ADVANCE Anchor with DYNATAPE Suture · Medos International SARL · Jun 4, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 18, 2021 Medos International SARL % Tatyana Korsunsky Regulatory Affairs Technical Manager DePuy Mitek, a Johnson and Johnson company 325 Paramount Drive Raynham, Massachusetts 02767 Re: K203186 Trade/Device Name: DYNATAPE Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: October 25, 2020 Received: October 27, 2020 Dear Tatyana 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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 mediation-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, Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203186 Device Name DYNATAPETM Suture Indications for Use (Describe) DYNATAPE suture is indicated for orthopedic procedural use in soft-tissue approximation, and or ligation, including use with allograft tissue. 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 ### DYNATAPE™ Suture Date Prepared: February 09, 2021 | 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 | Tatyana Korsunsky Regulatory Affairs Technical Manager DePuy Synthes Mitek Sports Medicine a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 Telephone: 508-828-3122 e-mail: tkorsuns@its.jnj.com | | Name of Medical Device | Proprietary Name: DYNATAPE™ Suture Classification Name: Polyethylene, suture, nonabsorbable, synthetic (21 CFR 878.5000) Common Name: Suture | | Substantial Equivalence | The DYNATAPE™ Suture is substantially equivalent to: K181182 DYNACORD™ Suture (MEDOS International SARL) Reference devices: K200949 HEALIX ADVANCE™ Anchor with DYNATAPE™ Suture (MEDOS International SARL) K183506 HEALIX ADVANCE™ Anchor with DYNACORD™ Suture (MEDOS International SARL) K021434, K041553 FiberWire® (Arthrex) | | Device Classification | DYNATAPETM Suture is classified as: | | | Polyethylene, suture, nonabsorbable, synthetic, classified as Class II, product code GAT, regulated under 21 CFR 878.5000. | | Device Description | DYNATAPE™ Suture is a sterile non-absorbable orthopedic suture. DYNATAPE™ Suture has a double sheath and core design, composed of Ultra High Molecular Weight Polyethylene and Polyester, with or without colorants, as well as a Silicone/NaCl core. DYNATAPE™ Suture's outer sheath is braided flat, with rounded tips. | | Technological Characteristics | The DYNATAPE™ Suture is a surgical suture, that meets USP knot tensile strength for size 2 non-absorbable sutures. As DYNATAPE™ Suture is flat, it does not follow USP suture diameter requirements. DYNATAPE™ Suture's outer sheath is braided flat to allow for a wider contact area with tissue. | | | When DYNATAPE™ Suture is placed in an aqueous environment, the salt particles within the silicone core elute out, leaving behind a micro-porous structure within the silicone core. These small voids are consequently filled with surrounding fluid as the core hydrates, resulting in a radial expansion of the suture. If laxity is present, this radial expansion of the braid causes an axial shortening of the total suture length. The self-tensioning property of DYNATAPE™ Suture is designed to resist laxity and minimize gap formation in a repair, by maintaining approximation force (compression) if laxity (looseness) is present. | | Comparison to the Predicate Devices | The DYNATAPE™ Suture, similar to the predicate device DYNACORD® (K181182), meets USP knot tensile requirements for size 2 suture. Both subject and predicate device have the same indications, intended use and materials. Both DYNATAPE™ and DYNACORE™ sutures are laxity resistant, as shown by approximation force testing. The sheath of the DYNATAPE™ Suture has been redesigned with a unique braiding pattern of ticker fibers to create the flattened structure specific to DYNATAPE™ | | | Suture, differentiating from the predicate device. DYNATAPE™ Suture is offered as a suture component of the reference predicate HEALIX ADVANCE™ Anchor with DYNATAPE™ Suture (K200949). | | Indications for Use | DYNATAPE suture is indicated for orthopedic procedural use in soft-tissue approximation, and/ or ligation, including use with allograft tissue. | | Non clinical Testing | USP Knot Tensile Strength, in-vitro approximation force over time, and sterility testing have been conducted. Biocompatibility, stability, in-vivo testing of the predicate device were included by reference (K181182). Bacterial endotoxin testing | {4}------------------------------------------------ {5}------------------------------------------------ | | has been completed as part of the HEALIX ADVANCE™ Anchor with DYNATAPE™ Suture (K200949), meeting the endotoxin limits. | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Safety and Performance | Results of non-clinical 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 device, the proposed DYNATAPE™ Suture has shown to be substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act. |