Parcus Titanium Interference Screws

K202662 · Parcus Medical, LLC · MBI · Feb 22, 2021 · Orthopedic

Device Facts

• Record ID: K202662
• Device Name: Parcus Titanium Interference Screws
• Applicant: Parcus Medical, LLC
• Product Code: MBI · Orthopedic
• Decision Date: Feb 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

Device Story

Parcus Titanium Interference Screw is a cannulated, threaded, tapered fastener used for interference fixation of ligaments and tendons during orthopedic repair procedures. Device is manufactured from Ti-6Al-4V ELI titanium alloy. It is intended for use by surgeons in clinical settings. The device functions as a mechanical anchor to secure soft tissue to bone. No changes to physical device design were made; submission primarily updates Instructions for Use to include MR Conditional parameters. Benefit to patient is stable fixation of ligaments or tendons during the healing process.

Clinical Evidence

Bench testing only. Performance data from the original predicate (K083619) regarding pull-out strength and insertion torque for 7mm and 12mm sizes demonstrated no significant differences compared to competitive devices. No new clinical data was required as the device design remains unchanged.

Technological Characteristics

Cannulated, threaded, tapered fastener. Material: Titanium alloy Ti-6Al-4V ELI (ASTM F136). Dimensions: 7-12mm diameter, 20-35mm length. Mechanical fixation principle. MR Conditional.

Indications for Use

Indicated for fixation of ligaments and tendons in patients requiring ligament or tendon repair.

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 Titanium Interference Screws (K083619)

Submission Summary (Full Text)

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February 22, 2021

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Parcus Medical, LLC Aleiandra Anderson QA Specialist 6423 Parkland Drive Sarasota, Florida 34243

Re: K202662/S001

Trade/Device Name: Parcus Titanium Interference Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: January 5, 2021 Received: January 19, 2021

Dear Alejandra Anderson:

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 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

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# K202662 - Alejandra Anderson

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 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.

Laura C. Rose, 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

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

# Indications for Use

510(k) Number (if known) K202662

Device Name

Parcus Titanium Interference Screw

Indications for Use (Describe)

The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair

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

网 Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Number: K202662 Received Date: 09/14/2020

K202662 Page 1 of 1

| 510(k) Summary | |
|---------------------------|-------------------------------------|
| 510(k) Owner & Submitter: | Parcus Medical, LLC |
| | 6423 Parkland Dr |
| | Sarasota, FL 34243 |
| Company Contact: | Alejandra Anderson |
| | Phone: [phone] |
| | Fax: [phone] |
| Date Prepared: | August 21st, 2020 |
| Device Trade Name: | Parcus Titanium Interference Screws |
| Common Name: | Interference Screws |
| Device Class: | Class II |
| Classification Name: | 21 CFR 888.3040 - Product Code MBI |

### Predicate Device:

Parcus Titanium Interference Screws, K083619, Cleared March 6, 2009.

## Device Description:

The Parcus Titanium Interference Screw is a cannulated, threaded, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length. Intended Use:

The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

## Substantial Equivalence Summary:

The Parcus Titanium Interference Screw is equivalent to the predicate Parcus Titanium Interfere Screws because they are the exact same device. No changes from the existing device are proposed with the exception of the inclusion of the MR Conditional parameters into the Instructions for Use. LAL testing has been tested on the Parcus Titanium Interference Screws and it was concluded that the Parcus Titanium Interference Screws do not raise any additional concerns regarding pyrogenicity.

### Summary Performance Data:

The pull-out strength and insertion torque were measured for the smallest (7mm) and largest (12mm) Parcus Titanium Interference Screws as well as an intermediate size. As described above, no changes to the physical device are being made and therefore additional side by side comparisons were not deemed necessary. Based on the performance data included with the submission of K083619, the results of the insertion torque testing and pullout force demonstrated that there were no significant differences between the Parcus Titanium Interference Screw and the competitive devices.

www.parcusmedical.com