(259 days)
No
The device description and performance studies focus on mechanical properties of bone plates and screws, with no mention of software, algorithms, or AI/ML terms.
No
The description states it is intended for fixation of complex intra- and extra-articular fractures and osteotomies, which is a supportive and structural function, not a therapeutic one.
No
The device is described as a system for fixation of fractures and osteotomies (bone repair), not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components like plates, screws, and pegs made of stainless steel and titanium, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones." This describes a surgical implant used to stabilize bone fractures.
- Device Description: The description details plates, screws, and pegs made of stainless steel or titanium, which are typical materials for orthopedic implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for 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.
Product codes
HRS, HWC
Device Description
The Arzzt Distal Radius and Ulna System consist in a 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius and other small bones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
K012114, K082072, K102694, K162507, K030310
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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2002 Timberloch Place Suite 200 The Woodlands, TX 77380 Telephone: 832 442 2310
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 |
| 2002 Timberloch Place Suite 200 | ||
| The Woodlands, TX 77380 | ||
| Telephone: 832 442 2310 | ||
| 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 |
| 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 |
| Plating System (K012114) | ||
| Additional Predicates: | ||
| Synthes (USA) 3.5ram LCP Hook Plate (K082072) | ||
| 2.4mmn 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 Predicate: | ||
| 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: 832 442 2310
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.
- 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.
-
- 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.