(231 days)
Not Found
No
The description focuses on the mechanical properties, materials, and design features of bone plates and screws for fracture fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for the fixation of fractures, osteotomies, and non-unions, and for wrist arthrodesis, which are therapeutic interventions.
No
The device is described as a system for fixation of fractures, osteotomies, and non-unions, and for wrist arthrodesis. It includes plates and screws, which are surgical implants used to stabilize bones, rather than to diagnose medical conditions.
No
The device description clearly outlines various physical components like plates, screws, and fasteners made of stainless steel and PEEK, indicating it is a hardware-based medical device for surgical fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures, osteotomies, and non-unions involving bones (radius, ulna, carpals), and wrist fusion. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates, screws, and fasteners made of materials like stainless steel and PEEK. These are implants used to stabilize bone structures.
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
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.
Product codes
HRS
Device Description
The Avanti Distal Radius and Forearm System includes volar plates, wrist fusion plates, spanning plates, forearm plates, ulnar plates, and cannulated screws, with screw and peg fasteners, for the fixation of fractures, malunions, and osteotomies. Distal radius and forearm fixation plates may be placed on the volar or dorsal surface of the radius and along the shaft of the radius and ulna on the carpal bones. Features of the system include pre-contoured plates to fit the anatomy of the distal radius, a low-profile design to minimize soft tissue irritation, low contact design to optimize blood supply, and bi-planar angulated screw holes for ease of drilling and to optimize fixation and subchrondral support.
All plates are manufactured from medical grade stainless steel per ASTM F138 or ASTM F139 and are electropolished per ASTM F-86. The Volar PEEK Plate has a polyetheretherkeytone that is preassembled to the plate and is sourced from Invibio, LTD. The PEEK insert allows insertion of both locking and non-locking 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 tissue irritation and the option of compression or locking cortical screws.
The Avanti Distal Radius and Forearm System includes self-tapping screws, listed below, that are manufactured from medical grade stainless steel per ASTM F138, electropolished per ASTM F-86, and are compatible with all Avanti plate configurations. All fasteners but the Cannulated Screw are intended to be used with the plates. The cannulated screws can be used for fracture fixation that is appropriately sized for the device which is determined through surgeon discretion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radius, ulna, and carpals
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
Non-clinical testing was performed to demonstrate the Avanti Distal Radius and Forearm System is substantially equivalent to other predicate devices. The following tests were performed: Static and dynamic plate loading per ASTM F382 Screw pullout strength via ASTM F543 Locking Mechanism Push-Out Testing
Key Metrics
Not Found
Predicate Device(s)
K132704, K042355, K951304, K000684, K160995
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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 PRAStaff@fda.hhs.gov "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
| Prepared | November 13, 2019 |
|---|---|
| Submitter | Avanti Orthopaedics, Inc |
| 4606 Simon Road | |
| Wilmington, DE 19803 | |
| Phone 302-530-6369 | |
| Fax 302-351-4896 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| Regulatory@SecureBME.com | |
| 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 | |
| Predicates | K042355 Synthes LCP Wrist Fusion Plates |
| K951304 Synthes 2.7 MM Cannulated Screw and Threaded Washer | |
| K000684 Synthes Small Fragment Dynamic Compression Locking (DCL) System | |
| K160995 In2Bones SAS Neoview Plate | |
| Device Description | The Avanti Distal Radius and Forearm System includes volar plates, wrist fusion |
| plates, spanning plates, forearm plates, ulnar plates, and cannulated screws, | |
| with screw and peg fasteners, for the fixation of fractures, malunions, and | |
| osteotomies. Distal radius and forearm fixation plates may be placed on the | |
| volar or dorsal surface of the radius and along the shaft of the radius and ulna | |
| on the carpal bones. Features of the system include pre-contoured plates to fit | |
| the anatomy of the distal radius, a low-profile design to minimize soft tissue | |
| irritation, low contact design to optimize blood supply, and bi-planar angulated | |
| screw holes for ease of drilling and to optimize fixation and subchrondral | |
| support. | |
| All plates are manufactured from medical grade stainless steel per ASTM F138 | |
| or ASTM F139 and are electropolished per ASTM F-86. The Volar PEEK Plate has | |
| a polyetheretherkeytone that is preassembled to the plate and is sourced from | |
| Invibio, LTD. The PEEK insert allows insertion of both locking and non-locking | |
| 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 | |
| tissue irritation and the option of compression or locking cortical screws. |
The Avanti Distal Radius and Forearm System includes self-tapping screws, listed
below, that are manufactured from medical grade stainless steel per ASTM
F138, electropolished per ASTM F-86, and are compatible with all Avanti plate
configurations. All fasteners but the Cannulated Screw are intended to be used
with the plates. The cannulated screws can be used for fracture fixation that is
appropriately sized for the device which is determined through surgeon
discretion. |
| 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. |
| Technological
Characteristics | The subject Avanti Distal Radius and Forearm System is technological similar to
other similarly intended devices in that it has the same technological
characteristics to its predicate devices through comparison in areas including
design, intended use, material composition, function, and range of sizes. The
subject system differences technologically in that the volar plate comes with a
pre-assembled PEEK insert. The PEEK insert allows insertion of both locking and
non-locking fasteners with variable angle up to 11 degrees using the drill guide
provided in the system. |
| Non-Clinical
Performance
Testing Conclusion | Non-clinical testing was performed to demonstrate the Avanti Distal Radius and
Forearm System is substantially equivalent to other predicate devices. The
following tests were performed:
Static and dynamic plate loading per ASTM F382 Screw pullout strength via ASTM F543 Locking Mechanism Push-Out Testing |
| Substantial
Equivalence
Summary | The Avanti Distal Radius and Forearm System has been shown to be substantially
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.