DYNACORD Suture

K181182 · Medos International SARL · GAT · Aug 2, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K181182
• Device Name: DYNACORD Suture
• Applicant: Medos International SARL
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Aug 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

DYNACORD Suture is a sterile, non-absorbable orthopedic suture featuring a double sheath and core design composed of Ultra High Molecular Weight Polyethylene (UHMWPE), Polyester, and a Silicone/NaCl core. Used by surgeons in orthopedic procedures for soft-tissue approximation and ligation. Upon placement in an aqueous environment, salt particles within the silicone core elute, creating micro-porous voids. These voids hydrate and expand radially, causing axial shortening of the suture length. This mechanism resists laxity and minimizes gap formation by maintaining approximation force (compression) on the tissue. The device is provided with needles for surgical application.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing and GLP in-vivo efficacy/safety evaluations. Bench testing included USP diameter, knot tensile strength, needle attachment, and in-vitro approximation force over time. Biocompatibility, sterility, shelf-life, and bacterial endotoxin testing were performed.

Technological Characteristics

Non-absorbable synthetic suture; materials include UHMWPE, Polyester, and Silicone/NaCl core. Double sheath and core design. Meets USP requirements except for oversized diameter. Radial expansion mechanism via salt elution and core hydration. 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

• FiberWire® (K021434)
• FiberWire® (K041553)

Reference Devices

• HEALIX ADVANCE™ Anchor with DYNACORD™ Suture (K173859)
• ORTHOCORD® Suture (K040004)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 2, 2018

Medos International SARL DePuy Mitek, a Johnson and Johnson company % Ms. Tatyana Korsunsky Regulatory Affairs Technical Manager 325 Paramount Drive Raynham, Massachusetts 02767

# Re: K181182

Trade/Device Name: DYNACORD™ Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: July 3, 2018 Received: July 5, 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

Device Name DYNACORD™ Suture

Indications for Use (Describe)

DYNACORD 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)

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

# DYNACORD™ Suture

# Date Prepared: June 27, 2018

| 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 Technical Manager<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br><br>Telephone: [phone]<br>e-mail: [e-mail] |
| Name of<br>Medical Device | Proprietary Name: DYNACORD™ Suture<br><br>Classification Name: Polyethylene, suture, nonabsorbable, synthetic (21 CFR 878.5000)<br><br>Common Name: Suture |
| Substantial<br>Equivalence | The DYNACORD™ Suture is substantially equivalent to:<br>K021434, K041553 FiberWire® (Arthrex)<br>Reference devices:<br>K173859 HEALIX ADVANCE™ Anchor with DYNACORD™ Suture (MEDOS International)K040004 ORTHOCORD® Suture (DePuy Mitek) |
| Device<br>Classification | DYNACORD™ Suture is classified as:<br>Polyethylene, suture, nonabsorbable, synthetic, classified as Class II, product code GAT, regulated under 21 CFR 878.5000. |
| Device<br>Description | DYNACORD™ Suture is a sterile non-absorbable orthopedic suture. DYNACORD™<br>Suture has a double sheath and core design, and contains Ultra High Molecular<br>Weight Polyethylene, Polyester and a Silicone/NaCl core. |
| Technological<br>Characteristics | The DYNACORD™ Suture is a surgical suture, that meets USP except for oversized<br>diameter. |
| | When DYNACORD™ Suture is placed in an aqueous environment, the salt particles<br>within the silicone core elute out, leaving behind a micro-porous structure within the<br>silicone core. These small voids are consequently filled with surrounding fluid as the<br>core hydrates, resulting in a radial expansion of the suture. If laxity is present, this<br>radial expansion of the braid causes an axial shortening of the total suture length.<br>The DYNACORD™ Suture is designed to resist laxity and minimize gap formation,<br>by maintaining approximation force (compression). |
| Comparison to<br>the Predicate<br>Devices | The DYNACORD™ Suture, similar to the predicate device FiberWire® (Arthrex,<br>K021434, K041553), meets USP requirements for size 2 suture, except for oversized<br>diameter. Both subject and predicate device have the same intended use of soft<br>tissue approximation. Both sutures contain UHMWPE and Polyester. FiberWire®<br>(Arthrex) contains Silicone coating. DYNACORD™ Suture contains Silicone/NaCl<br>core. |
| | The silicone/NaCl core is the main technological difference between the<br>DYNACORD™ Suture and FiberWire® (Arthrex) Suture. |
| | The DYNACORD™ Suture is identical to the suture component of the reference<br>predicate HEALIX ADVANCE™ Anchors with DYNACORD™ Suture (K173859). |
| | The needles provided with DYNACORD™ Suture are also used with reference<br>predicate device ORTHOCORD®(K040004). |
| Indications for<br>Use | DYNACORD™ suture is indicated for orthopedic procedural use in soft-tissue<br>approximation, and/or ligation, including use with allograft tissue. |
| Non clinical<br>Testing | Performance testing included: USP Diameter (DYNACORD™ is oversized), USP<br>Knot Tensile Strength, USP Needle Attachment, <i>in-vitro</i> approximation force over<br>time, GLP <i>in-vivo</i> efficacy evaluation. Safety testing included: biocompatibility,<br>sterility, shelf-life, GLP <i>in-vivo</i> evaluation of DYNACORD™ safety. Bacterial<br>endotoxin testing has been completed and results have demonstrated that the<br>proposed devices meet the endotoxin limits. |
| Safety and<br>Performance | Results of non-clinical 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>device, the proposed DYNACORD™ Suture has shown to be substantially<br>equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act. |

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