(53 days)
No
The 510(k) summary describes a system of plates and screws for ulnar shortening osteotomy, made of stainless steel. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies section also focuses on engineering analysis compared to a predicate device, not algorithmic performance.
Yes
The device is described as "implants designed for wrist and forearm conditions" to address pain and dysfunction, indicating it directly treats a medical condition.
No
The device is described as a system of implants (plates and screws) used for surgical ulnar shortening osteotomy. Its purpose is to correct a physical condition (ulna longer than the radius causing pain/dysfunction), not to diagnose it.
No
The device description explicitly states it includes plates and screws manufactured from stainless steel, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Avanti Orthopaedics Ulnar Shortening System is a system of implants (plates and screws) designed to be surgically implanted into the body to correct a physical condition (ulnar shortening).
- Intended Use: The intended use is for a surgical procedure (ulnar shortening osteotomy), not for analyzing biological specimens.
The information provided clearly describes a surgical implant system, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Avanti Orthopaedics Ulnar Shortening System is intended for ulnar shortening osteotomy.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ulna, wrist, forearm
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
1
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, 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. | |
| Patricia Jones | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| Regulatory@SecureBME.com | |
| Trade Name | Avanti Orthopaedics Ulnar Shortening System |
| Common Name | Plate, Fixation, Bone |
| Classification Name | Single/Multiple component metallic bone fixation appliances and |
| accessories | |
| 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 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. | |
| Indications for Use | The Avanti Orthopaedics Ulnar Shortening System is intended for ulnar |
| shortening osteotomy. | |
| Technological Characteristics | The subject Avanti Orthopaedics Ulnar Shortening 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. | |
| Non-Clinical Performance | |
| Testing Conclusion | 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. | |
| Substantial Equivalence | |
| Summary (Conclusion) | The Avanti Orthopaedics Ulnar Shortening System has been shown |
| to be substantially equivalent to legally marketed predicate devices. |