Dunamis PunchTac Suture Anchors

K193245 · Dunamis, LLC · MBI · Feb 14, 2020 · Orthopedic

Device Facts

• Record ID: K193245
• Device Name: Dunamis PunchTac Suture Anchors
• Applicant: Dunamis, LLC
• Product Code: MBI · Orthopedic
• Decision Date: Feb 14, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

Sterile, single-use implantable suture anchor system; used for reattaching soft tissue to bone. System includes threaded, push-in, or knotless suture anchors; USP Size 2 Ultra High Molecular Weight Polyethylene (UHMWPE) suture or suture tape; and inserter tool. Used by orthopedic surgeons in clinical settings (OR) to perform repairs (e.g., rotator cuff, Bankart, Achilles tendon). Surgeon inserts anchor into bone; suture secures soft tissue to anchor. Provides mechanical fixation to facilitate healing and restore joint stability.

Clinical Evidence

Bench testing only. Evidence includes pull-out strength testing, insertion testing, and LAL testing for orthopedic implants. No clinical data provided.

Technological Characteristics

Implantable suture anchor system. Materials: UHMWPE (suture/tape). Designs: Threaded, push-in, knotless. Sterile, single-use. Mechanical fixation principle. No energy source or software.

Indications for Use

Indicated for patients requiring soft tissue-to-bone reattachment in shoulder, elbow, foot, ankle, knee, and hip procedures, including ligament/tendon repairs, reconstructions, and stabilization.

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

• Dunamis Suture Anchor PEEK (K160996)
• Smith & Nephew OSTEORAPTOR (K082215)
• Smith & Nephew TWINFIX (K112526)

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, 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

{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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## 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

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)

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.

{3}------------------------------------------------

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 [e-mail]

"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."

{4}------------------------------------------------

# 510(k) Summary

| Manufacturer: | Dunamis Medical , LLC<br>509 E. Commerce Street, Suite 3<br>Greenville, AL 36037<br>Phone: [phone] |
|---------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Dr. PrithviRaj Chavan<br>President |
| Prepared By: | MCRA, LLC<br>1050 K Street, NW, Suite 1000<br>Washington, DC 20001<br>Phone: [phone] |
| 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

{5}------------------------------------------------

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

## 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.