Arzzt Distal Radius and Ulna System

K182650 · Truemed Group, LLC · HRS · Jun 10, 2019 · Orthopedic

Device Facts

• Record ID: K182650
• Device Name: Arzzt Distal Radius and Ulna System
• Applicant: Truemed Group, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Jun 10, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arzzt Distal Radius and Ulna System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

Device Story

Arzzt Distal Radius and Ulna System comprises bone plates and screws for orthopedic fixation; used for complex intra- and extra-articular fractures and osteotomies of distal radius and small bones. System includes plates for dorsal/volar use with orifices for locking/non-locking screws; screws available as fully/partially threaded, self-tapping, with/without locking features; locking pegs also available. Device is non-sterile, single-use. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization of bone fragments to facilitate healing.

Clinical Evidence

Bench testing only. Engineering analyses compared static bending and static torsional yield strengths against predicates. Screw performance evaluated via ASTM F543 testing, comparing maximum shear stress and thread characteristics to predicate devices.

Technological Characteristics

Materials: Stainless steel (ASTM F138) and titanium (ASTM F136). Components: Plates (dorsal/volar) and screws (locking/non-locking, self-tapping, fully/partially threaded) and locking pegs. Mechanical fixation principle. Non-sterile, single-use.

Indications for Use

Indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes Locking Distal Radius Plating System (K012114)
• Synthes (USA) 3.5mm LCP Hook Plate (K082072)
• 2.4mm Variable Angle LCP Dorsal Distal Radius System (K102694)
• Arzzt 3.5 / 4.5 Small & Large Fragments System (K162507)
• Synthes Stainless Steel Modular Hand System (K030310)

Reference Devices

• Ins Hilden Tibial Arzzt (K133166)

Submission Summary (Full Text)

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June 10, 2019

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Truemed Group LLC Nina Rodriguez Coordinator 2002 Timberloch Place Suite 200 The Woodlands, Texas 77380

Re: K182650

Trade/Device Name: Arzzt Distal Radius and Ulna System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: May 2, 2019 Received: May 6, 2019

Dear Nina Rodriguez:

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,

Shumaya Ali, MPH 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) K182650

Device Name

Arzzt Distal Radius and Ulna System

Indications for Use (Describe)

The Arzzt Distal Radius and Ulna System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

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

| <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-----------------------------------------------------------------------------|
| <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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2002 Timberloch Place Suite 200 The Woodlands, TX 77380 Telephone: [phone]

Image /page/3/Picture/2 description: The image shows the logo for TrueMed Group. The logo consists of a teal-colored symbol on the left, resembling a person inside a circle with two curved lines on either side. To the right of the symbol, the word "TRUEMED" is written in a bold, dark gray font, with the word "GROUP" underneath in a smaller, teal font. A horizontal line extends from the right side of the word "GROUP".

# Premarket Notification 510(k) Summary

| 1. | Submitter's Name: | Truemed Group LLC |
|-----|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact Person: | Jorge Trujillo Zavala<br>2002 Timberloch Place Suite 200<br>The Woodlands, TX 77380<br>Telephone: [phone] |
| 3. | Date Prepared: | September 12th, 2018 |
| 4. | Device Name: | Arzzt Distal Radius and Ulna System |
| 5. | Common Name: | Osteosynthesis plates and screws |
| 6. | Classification Name: | • Plate, Fixation, Bone and accessories per 21 CFR<br>section 888.3030 |
| 7. | Product Codes: | HRS, HWC |
| 8. | Devices Classification: | Class II |
| 9. | Regulation Numbers: | 21 CFR 888.3030 21 CFR 888.3040 |
| 10. | Predicate Devices: | Primary Predicate: Synthes Locking Distal Radius<br>Plating System (K012114)<br>Additional Predicates:<br>Synthes (USA) 3.5ram LCP Hook Plate (K082072)<br>2.4mmn Variable Angle LCP Dorsal Distal Radius<br>System (K102694)<br>Arzzt 3.5 / 4.5 Small & Large Fragments System<br>(K162507)<br>Synthes Stainless Steel Modular Hand System<br>(K030310)<br>Reference Predicate:<br>Ins Hilden Tibial Arzzt (K133166) |
| 11. | Device Description: | The Arzzt Distal Radius and Ulna System consist in a |

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2002 Timberloch Place Suite 200 The Woodlands, TX 77380 Telephone: [phone]

Image /page/4/Picture/2 description: The image is a logo for TrueMed Group. The logo consists of a teal-colored abstract symbol on the left, resembling a person within a circle. To the right of the symbol, the word "TRUEMED" is written in a bold, dark gray font, with the word "GROUP" in a smaller, teal font below it. A horizontal line extends from the word "GROUP" to the right.

14. Non-Clinical Testing:

variety of plates intended for dorsal and volar use, with orifices to receive either locking or non-locking screws. The screws are can be total or partially threaded, some are self-tapping and they can be with or without locking features. System is also available with locking pegs. All plates and screws may be manufactured in stainless steel (ASTM F138) and titanium (ASTM F136). The System is non-sterile and single use only.

### 12. Technological Characteristic comparison:

- Similarities: Single use devices. Same materials of o manufacture. Similar compatible screw sizes, and plate tvpes Differences: The specific geometries of the plates O differ (e.g., tip point features, decreased cortical surface complexity/flat undersurface design)
- The Arzzt Distal Radius and Ulna System is intend to 13. Intended Use: use for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
- We performed engineering analyses comparing the static bending and static torsional vield strengths of the Arzzt locking plates to the predicate devices proving to be as strong as the predicate devices. For the screws, we performed ASTM F543 testing and engineering analyses comparing the maximum shear stress and thread of the Arzzt locking and cortical screws to the predicate device.
- 15. Conclusion: Based on the testing and technological properties of the subject device as compared to the predicate device, we believe that no new questions of safety and effectiveness have been raised, and that the subject device is substantially equivalent to the predicate devices.