Avanti Orthopaedics Ulnar Shortening System by Avanti Orthopaedics, Inc.

The Avanti Orthopaedics Ulnar Shortening System implants are designed for wrist and forearm conditions in which the ulna is, either statically or dynamically, longer than the radius and causing pain and/or dysfunction due to derangement of the distal radioulnar joint (DRUJ) and/or impaction of the carpus. The Avanti Orthopaedics Ulnar Shortening System plates and screws are manufactured from 316LS medical grade implant quality stainless steel. The Avanti Orthopaedics Ulnar Shortening System plate should only be used with the appropriately sized Avanti Orthopaedics screws. The lag screw hole in the ulnar shortening plate provides for orthogonal, compressive fixation of the osteotomy.

AI/ML Overview

This document refers to a medical device, the Avanti Orthopaedics Ulnar Shortening System, not an AI/ML-driven device. Therefore, the questions regarding acceptance criteria, study details, ground truth establishment, and training/test set data are not applicable in the context of an AI/ML device approval.

The 510(k) summary provided in the input focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics, material composition, and intended use.

Here's a breakdown of the relevant information provided:

Acceptance Criteria and Reported Device Performance: This section is not applicable in the context of AI/ML performance metrics. The submission focuses on demonstrating substantial equivalence to predicate devices. The "Non-Clinical Performance Testing Conclusion" states: "Although non-clinical testing was not necessary, an engineering analysis was provided to show the subject system did not create a new worst case as compared to the reference device K191118 Avanti Distal Radius and Forearm System." This implies that the device's mechanical properties and safety profile are considered acceptable based on comparison to an existing device, rather than specific performance metrics against pre-defined acceptance criteria.
Sample Size and Data Provenance: Not applicable for an AI/ML study. The approval is for a physical medical implant.
Number of Experts and Qualifications: Not applicable for an AI/ML study.
Adjudication Method: Not applicable for an AI/ML study.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable for a physical medical implant.
Standalone Performance: Not applicable for a physical medical implant.
Type of Ground Truth Used: Not applicable for an AI/ML study. For a physical implant, the "ground truth" would be established through engineering analysis, material testing, and clinical outcomes in predicate devices.
Sample Size for Training Set: Not applicable for a physical medical implant.
How Ground Truth for Training Set Was Established: Not applicable for a physical medical implant.

In summary: The provided document is for the regulatory clearance of a physical orthopedic implant, not an AI/ML software device. Therefore, the detailed questions about acceptance criteria, study design, and ground truth for AI/ML performance are not relevant to this specific regulatory submission. The clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices, which focuses on aspects like material, design, and intended use.

Summary

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July 16, 2021

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

Re: K211592

Trade/Device Name: Avanti Orthopaedics Ulnar Shortening 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 Dated: May 19, 2021 Received: May 24, 2021

Dear Linda Braddon:

We have reviewed vour 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

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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 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,

Jesse Muir -S

For: Shumaya Ali, M.P.H. 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) K211592

Device Name

Avanti Orthopaedics Ulnar Shortening System

Indications for Use (Describe)

The Avanti Orthopaedics Ulnar Shortening System is intended for ulnar shortening osteotomy.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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

Date Summary Prepared	July 16, 2021
Submitter	Avanti Orthopaedics, Inc4606 Simon RoadWilmington, DE 19803Phone 302-530-6369Fax 302-351-4896
510(k) Contact	Secure BioMed EvaluationsLinda Braddon, Ph.D.Patricia Jones7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com
Trade Name	Avanti Orthopaedics Ulnar Shortening System
Common Name	Plate, Fixation, Bone
Classification Name	Single/Multiple component metallic bone fixation appliances andaccessories
Code -Classification	HRS, 21 CFR 888.3030: Class II
Primary Predicate	K142502 New Clip Alians Ulna Locking Plating System
Additional Predicates	K141232 Medartis Aptus Ulna Shortening 2.5
Reference Device	K191118 Avanti Distal Radius and Forearm System
Device Description	The Avanti Orthopaedics Ulnar Shortening System implants aredesigned for wrist and forearm conditions in which the ulna is, eitherstatically or dynamically, longer than the radius and causing pain and/ordysfunction due to derangement of the distal radioulnar joint (DRUJ)and/or impaction of the carpus. The Avanti Orthopaedics UlnarShortening System plates and screws are manufactured from 316LSmedical grade implant quality stainless steel. The Avanti OrthopaedicsUlnar Shortening System plate should only be used with theappropriately sized Avanti Orthopaedics screws. The lag screw hole inthe ulnar shortening plate provides for orthogonal, compressive fixationof the osteotomy.
Indications for Use	The Avanti Orthopaedics Ulnar Shortening System is intended for ulnarshortening osteotomy.
Technological Characteristics	The subject Avanti Orthopaedics Ulnar Shortening System istechnological similar to other similarly intended devices in that it hasthe same technological characteristics to its predicate devicesthrough comparison in areas including design, intended use, materialcomposition, function, and range of sizes.
Non-Clinical PerformanceTesting Conclusion	Although non-clinical testing was not necessary, an engineeringanalysis was provided to show the subject system did not create anew worst case as compared to the reference device K191118 AvantiDistal Radius and Forearm System.
Substantial EquivalenceSummary (Conclusion)	The Avanti Orthopaedics Ulnar Shortening System has been shownto be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 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.