Avanti Distal Radius and Forearm System

K191118 · Avanti Orthopaedics, Inc. · HRS · Dec 13, 2019 · Orthopedic

Device Facts

• Record ID: K191118
• Device Name: Avanti Distal Radius and Forearm System
• Applicant: Avanti Orthopaedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Dec 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The system intended for fixation of fractures, osteotomies, malunions, and non-unions, involving the radius, ulna, and carpals. Additionally, the wrist fusion plates may be used for wrist arthrodesis.

Device Story

System comprises metallic bone fixation plates (volar, wrist fusion, spanning, forearm, ulnar) and fasteners (screws, pegs); used for fracture fixation, osteotomies, malunions, non-unions, and wrist arthrodesis. Plates feature pre-contoured anatomy, low-profile design, and bi-planar angulated screw holes. Volar plates include pre-assembled PEEK inserts allowing variable angle (up to 11 degrees) for locking/non-locking fasteners. Surgeons operate device in clinical/OR settings to stabilize bone segments. Output is physical fixation of bone; aids in bone healing and structural restoration.

Clinical Evidence

Bench testing only. Performed static and dynamic plate loading (ASTM F382), screw pullout strength (ASTM F543), and locking mechanism push-out testing to demonstrate substantial equivalence.

Technological Characteristics

Plates/screws manufactured from medical grade stainless steel (ASTM F138/F139), electropolished (ASTM F86). Volar plates include PEEK inserts (Invibio, LTD). Features low-profile geometry, bi-planar angulated screw holes, and compression or locking cortical screw options. Mechanical fixation device; no software or energy source.

Indications for Use

Indicated for fixation of fractures, osteotomies, malunions, and non-unions of the radius, ulna, and carpals; wrist arthrodesis using wrist fusion plates. Patient population includes individuals requiring orthopedic bone fixation.

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

• Biomet Distal Radius Volar Rim (DVR) Plating System (K132704)
• Synthes LCP Wrist Fusion Plates (K042355)
• Synthes 2.7 MM Cannulated Screw and Threaded Washer (K951304)
• Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684)
• In2Bones SAS Neoview Plate (K160995)

Submission Summary (Full Text)

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December 13, 2019

Avanti Orthopaedics, Inc. % Linda Braddon President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K191118

Trade/Device Name: Avanti Distal Radius and Forearm 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: November 13, 2019 Received: November 14, 2019

Dear Linda Braddon:

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.

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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 (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 (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 medical devices and radiation-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 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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known)

K191118

Device Name

Avanti Distal Radius and Forearm System

Indications for Use (Describe)

The system intended for fixation of fractures, osteotomies, and non-unions, involving the radius, ulna, and carpals. Additionally, the wrist fusion plates may be used for wrist arthrodesis.

Type of Use (Select one or both, as applicable) □ Over-The-Counter Use (21 CFR 801 Subpart C) 区 Prescription Use (Part 21 CFR 801 Subpart D)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

FORM FDA 3881 (7/17)

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K191118 Page 1/2

Image /page/3/Picture/1 description: The image shows the logo for Avanti Orthopaedics. The logo is in blue and features a stylized letter "A" with a swooping line extending from the bottom of the "A" to underline the rest of the word "vanti". Below the word "Avanti" is the word "ORTHOPAEDICS" in smaller, sans-serif font.

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the Avanti Distal Radius and Forearm System is provided below.

| Date Summary<br>Prepared | November 13, 2019 |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Avanti Orthopaedics, Inc<br>4606 Simon Road<br>Wilmington, DE 19803<br>Phone [phone]<br>Fax [phone] |
| 510(k) Contact | Secure BioMed Evaluations<br>Linda Braddon, Ph.D.<br>7828 Hickory Flat Highway<br>Suite 120<br>Woodstock, GA 30188<br>770-837-2681<br>[e-mail] |
| Trade Name | Avanti Distal Radius and Forearm System |
| Common Name | Single/Multiple component metallic bone fixation appliances and accessories |
| Code -Classification | HRS, 21 CFR 888.3030: Class II |
| Primary Predicate | K132704 Biomet Distal Radius Volar Rim (DVR) Plating System |
| Additional<br>Predicates | K042355 Synthes LCP Wrist Fusion Plates<br>K951304 Synthes 2.7 MM Cannulated Screw and Threaded Washer<br>K000684 Synthes Small Fragment Dynamic Compression Locking (DCL) System<br>K160995 In2Bones SAS Neoview Plate |
| Device Description | The Avanti Distal Radius and Forearm System includes volar plates, wrist fusion<br>plates, spanning plates, forearm plates, ulnar plates, and cannulated screws,<br>with screw and peg fasteners, for the fixation of fractures, malunions, and<br>osteotomies. Distal radius and forearm fixation plates may be placed on the<br>volar or dorsal surface of the radius and along the shaft of the radius and ulna<br>on the carpal bones. Features of the system include pre-contoured plates to fit<br>the anatomy of the distal radius, a low-profile design to minimize soft tissue<br>irritation, low contact design to optimize blood supply, and bi-planar angulated<br>screw holes for ease of drilling and to optimize fixation and subchrondral<br>support.<br>All plates are manufactured from medical grade stainless steel per ASTM F138<br>or ASTM F139 and are electropolished per ASTM F-86. The Volar PEEK Plate has<br>a polyetheretherkeytone that is preassembled to the plate and is sourced from<br>Invibio, LTD. The PEEK insert allows insertion of both locking and non-locking<br>fasteners with an infinite variable angle up to 11 degrees using the drill guide |
| | provided in the system. All plates include low-profile geometry to minimize soft<br>tissue irritation and the option of compression or locking cortical screws.<br><br>The Avanti Distal Radius and Forearm System includes self-tapping screws, listed<br>below, that are manufactured from medical grade stainless steel per ASTM<br>F138, electropolished per ASTM F-86, and are compatible with all Avanti plate<br>configurations. All fasteners but the Cannulated Screw are intended to be used<br>with the plates. The cannulated screws can be used for fracture fixation that is<br>appropriately sized for the device which is determined through surgeon<br>discretion. |
| Intended Use | The system intended for fixation of fractures, osteotomies, malunions, and non-<br>unions, involving the radius, ulna, and carpals. Additionally, the wrist fusion<br>plates may be used for wrist arthrodesis. |
| Technological<br>Characteristics | The subject Avanti Distal Radius and Forearm System is technological similar to<br>other similarly intended devices in that it has the same technological<br>characteristics to its predicate devices through comparison in areas including<br>design, intended use, material composition, function, and range of sizes. The<br>subject system differences technologically in that the volar plate comes with a<br>pre-assembled PEEK insert. The PEEK insert allows insertion of both locking and<br>non-locking fasteners with variable angle up to 11 degrees using the drill guide<br>provided in the system. |
| Non-Clinical<br>Performance<br>Testing Conclusion | Non-clinical testing was performed to demonstrate the Avanti Distal Radius and<br>Forearm System is substantially equivalent to other predicate devices. The<br>following tests were performed:<br>Static and dynamic plate loading per ASTM F382 Screw pullout strength via ASTM F543 Locking Mechanism Push-Out Testing |
| Substantial<br>Equivalence<br>Summary | The Avanti Distal Radius and Forearm System has been shown to be substantially<br>equivalent to legally marketed predicate devices. |

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Image /page/4/Picture/1 description: The image shows the logo for Avanti Orthopaedics. The logo is blue and features the word "Avanti" in a stylized font. Below "Avanti" is the word "ORTHOPAEDICS" in a smaller, sans-serif font. The logo is simple and professional.