Shoulder Capsular stabilization Bankart repair Anterior shoulder instability repair SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/ reconstructions Achilles tendon repairs/ reconstructions Midfoot reconstructions Metatarsal ligament/ tendon repairs/ reconstructions Bunionectomy

Knee

Extra-capsular repairs: medial collateral ligament, lateral ligament, posterior oblique ligament

Patellar realignment and tendon repairs: vastus medialis obliquous advancement, Iliotibial band tenodesis

Hip

Hip capsule repair Acetabular labrum reattachment Abductor tendon repair (in anchors 4.5mm - 6.5mm)

Device Description

The Dunamis PunchTac Suture Anchors is a sterile single use implantable suture anchor system designed to provide fixation and reattachment of soft tissue to bone. The system consists of the following components:

Suture Anchor (threaded, push-in and knotless designs)
. USP Size 2, White & Blue, CoBraid Ultra High Molecular Weight Polyethylene Suture(s) or Suture Tape (provided in configurations with suture only)
. Inserter Tool

AI/ML Overview

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA to Dunamis LLC for their PunchTac Suture Anchors.

It primarily details:

The FDA's determination of substantial equivalence for the Dunamis PunchTac Suture Anchors to legally marketed predicate devices.
The regulatory classification and product codes for the device.
The intended indications for use of the suture anchors.
A brief description of the device components.
The predicate devices used for comparison.
Statements indicating that testing was performed (pull-out strength and insertion testing) and that the device met "pre-determined acceptance criteria identified in the Design Control Activities" and LAL testing requirements. However, it does not specify what those acceptance criteria were, what the reported performance was, or provide details about the study itself.

Therefore, I cannot provide the requested information from this document.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

February 14, 2020

Dunamis LLC % Hollace Rhodes VP, Orthopedic Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

Re: K193245

Trade/Device Name: Dunamis PunchTac Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: January 17, 2020 Received: January 17, 2020

Dear Ms. Rhodes:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laura C. Rose, PhD Acting 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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Indications for Use

510(k) Number (if known) K193245

Device Name Dunamis PunchTac Suture Anchors

Indications for Use (Describe)

The Dunamis PunchTac Suture Anchors are intended to be used for reattachment of soft tissue to bone for the following indications:

Shoulder Capsular stabilization Bankart repair Anterior shoulder instability repair SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Knee

Extra-capsular repairs: medial collateral ligament, lateral ligament, posterior oblique ligament Patellar realignment and tendon repairs: vastus medialis obliquous advancement, Iliotibial band tenodesis

Hip Hip capsule repair Acetabular labrum reattachment Abductor tendon repair (in anchors 4.5mm - 6.5mm)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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.

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510(k) Summary

Manufacturer:	Dunamis Medical , LLC509 E. Commerce Street, Suite 3Greenville, AL 36037Phone: 731.217.2533
Contact:	Dr. PrithviRaj ChavanPresident
Prepared By:	MCRA, LLC1050 K Street, NW, Suite 1000Washington, DC 20001Phone: 202.552.5800
Date Prepared:	January 17, 2020
Device Trade Name:	Dunamis PunchTac Suture Anchors
Device Common Name:	Fastener, fixation, nondegradable, soft tissue
Classification:	21 CFR 888.3040 – Fastener, fixation, nondegradable, soft tissue
	Class II
Product Codes:	MBI

Indications for Use:

The Dunamis PunchTac Suture Anchors are intended to be used for reattachment of soft tissue to bone for the following indications:

Shoulder Capsular stabilization Bankart repair Anterior shoulder instability repair SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair

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Biceps tendon reattachment

Knee

Extra-capsular repairs: medial collateral ligament, lateral ligament, posterior oblique ligament

Patellar realignment and tendon repairs: vastus medialis obliquous advancement, Iliotibial band tenodesis

Hip

Hip capsule repair Acetabular labrum reattachment Abductor tendon repair (in anchors 4.5mm - 6.5mm)

Device Description:

Suture Anchor (threaded, push-in and knotless designs)
. USP Size 2, White & Blue, CoBraid Ultra High Molecular Weight Polyethylene Suture(s) or Suture Tape (provided in configurations with suture only)
. Inserter Tool

Predicate Devices:

The Dunamis PunchTac Suture Anchors with knotless anchors is substantially equivalent to the Dunamis Suture Anchor PEEK (K160996) with respect to indications, design, materials, and function. The Dunamis PunchTac Suture Anchors is substantially equivalent to the reference predicates, Smith & Nephew OSTEORAPTOR (K082215) and Smith & Nephew TWINFIX (K112526) with respect to indications and mechanical performance. The information summarized in the Design Control Activities Summary demonstrates that the modified Dunamis PunchTac Suture Anchors met the pre-determined acceptance criteria for the verification activities.

Substantial Equivalence:

The subject device underwent pull-out strength and insertion testing. The results of this testing demonstrates that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities. Additionally, the Dunamis PunchTac Suture Anchors is in compliance with LAL testing requirements for orthopaedic implants.

Regulation Number and Section

N/A