Parcus Synd-EZ SS

K192964 · Parcus Medical, LLC · MBI · Nov 22, 2019 · Orthopedic

Device Facts

• Record ID: K192964
• Device Name: Parcus Synd-EZ SS
• Applicant: Parcus Medical, LLC
• Product Code: MBI · Orthopedic
• Decision Date: Nov 22, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Parcus Synd-EZ SS is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. The Parcus Synd-EZ SS is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis (syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

Device Story

Synd-EZ SS is a fixation device for stabilizing syndesmosis during healing; consists of two buttons connected by UHMWPE suture. Device allows length adjustment and resists elongation without requiring knots. Used by surgeons in clinical settings for orthopedic trauma; provides mechanical fixation during bone healing process. Benefits patient by stabilizing syndesmotic disruptions; serves as adjunct to plates, rods, or casting. Device is provided sterile.

Clinical Evidence

Bench testing only. Side-by-side performance testing compared the subject device to the predicate device. Evaluation included strength and elongation testing under cyclic loading and ultimate failure conditions using test blocks and fixtures. Results demonstrated substantial equivalence to the predicate. Biocompatibility assessment conducted per ISO 10993-1; LAL testing confirmed no pyrogenicity concerns.

Technological Characteristics

Materials: medical grade titanium, stainless steel, and UHMWPE suture. Design: two-button system with suture linkage for adjustable length fixation. Sterilization: provided sterile. Connectivity: none (mechanical device).

Indications for Use

Indicated for patients requiring fixation during healing of syndesmotic trauma, including Weber B and Weber C ankle fractures, and as an adjunct in fracture repair of metaphyseal/periarticular small bone fragments or with external/intramedullary fixation systems.

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

• Parcus Synd-EZ Ti (K191783)

Submission Summary (Full Text)

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Parcus Medical, LLC Paul Vagts Director of Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243

Re: K192964

Trade/Device Name: Parcus Synd-EZ SS Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 22, 2019 Received: October 23, 2019

Dear Mr. Vagts:

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

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

Sincerely,

Laurence D. Coyne, Ph.D. Acting 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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510(k) Number (if known)

Device Name

#### Parcus Synd-EZ SS

FORM FDA 3881 (7/17)

Indications for Use (Describe)

The Parcus Synd-EZ SS is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

The Parcus Synd-EZ SS is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

Type of Use (Select one or both, as applicable)

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| <span style="text-decoration: underline;"></span> | <span style="text-decoration: underline;"></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Surgical Innovation | Customer Driven

| | 510(k) Summary |
|---------------------------|-------------------------------------------------|
| 510(k) Owner & Submitter: | Parcus Medical, LLC |
| | 6423 Parkland Dr |
| | Sarasota, FL 34243 |
| Company Contact: | Paul Vagts |
| | Phone: [phone] |
| | Fax: [phone] |
| Date Prepared: | November 15, 2019 |
| Device Trade Name: | Synd-EZ SS |
| Common Name: | Fastener, Fixation, Non-Degradable, Soft Tissue |
| Device Class: | Class II |
| Classification Name: | 21 CFR 888.3040 - Product Code MBI |
| Predicate Device: | Parcus Synd-EZ Ti, K191783, October 9, 2019. |

## Device Description:

The Parcus Synd-EZ SS consists of two buttons with suture connecting them and are designed to be used for stabilizing the syndesmosis during healing. Building upon the technology of the Parcus Synd-EZ Ti, the Synd-EZ SS is easily adjusted for length and resists elongation without requiring knots to secure the fixation. The device is made from medical grade titanium, stainless steel and UHMWPE suture and is provided sterile.

### Intended Use:

The Parcus Synd-EZ SS is intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

The Parcus Synd-EZ SS is intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis (syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.

### Substantial Equivalence Summary:

The Synd-EZ SS is very similar to the predicate Parcus Medical Synd-EZ Ti in that they both utilize titanium and UHMWPE suture, are intended for the same indications and both utilize the same design. LAL testing was conducted on a representative device comprised of similar materials and it was concluded that the Synd-EZ SS does not raise any additional concerns regarding pyrogenicity. A biocompatibility assessment was

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Surgical Innovation | Customer Driven

conducted in alignment with FDA guidance regarding the use of ISO 10993-1. Based on this biocompatibility assessment, side by side performance testing, and further comparison with the predicate device, it is our determination that the Synd-EZ is substantially equivalent to the predicate device.

#### Summary Performance Data:

The Synd-EZ SS was evaluated and testing was conducted side by side with the predicate device. Devices were assembled to test blocks and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results were compared with test data for the predicate device and demonstrated substantial equivalency.