(56 days)
No
The device description and performance studies focus on the mechanical properties and design of bone plates and screws, with no mention of software, algorithms, or AI/ML capabilities.
No
This device is an orthopedic plating system intended for the internal fixation of bone fractures, which is a supportive and mechanical function rather than a therapeutic one that directly heals or treats the underlying condition.
No
The device is an orthopedic plating system used for fixing fractures and performing osteotomies, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of physical components like plates, screws, accessories, and sterilization trays, all manufactured from titanium alloy. This indicates a hardware-based medical device, not a software-only one.
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 and other issues of the proximal tibia. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of plates and screws made of titanium alloy, designed for internal fixation. These are implantable medical devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used for diagnostic purposes by analyzing samples outside the body. This device is used for therapeutic purposes by being implanted inside the body.
N/A
Intended Use / Indications for Use
The AOS Fibonacci Proximal Tibia Plating System is intended for the fixation of fractures, malunions, osteopenic bone, and tibial osteotomies of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
Product codes
HRS
Device Description
The AOS Proximal Tibia Plating System consists of precontoured, single use, open reduction internal fixation Lateral Proximal Tibia Plates and Posteromedial Proximal Tibia Plates, manufactured from titanium alloy, and AOS Fibonacci screws 3.5mm in diameter or larger. These plates and screws, and their dedicated accessories and sterilization trays, will be added to the AOS Fibonacci Lower Extremity Plating System. The 4.0mm Fixed Angle Locking Screws are single use titanium alloy orthopedic fixation screws, designed for use with all plates in the Fibonacci Lower Extremity Plating System, including the proximal tibia plates. The 3.5mm Diamond Workhorse Screws are single use titanium alloy orthopedic fixation screws with a faceted cut core diameter, designed for use with all plates in the Fibonacci Lower Extremity Plating System, including the proximal tibia plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal tibia
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)
The AOS Proximal Tibia Plating System was subjected to internal engineering analysis, static and fatigue four-point bend testing per ASTM F382, and torsion strength, insertion torque, and pullout strength testing per ASTM F543. The results demonstrate that the AOS Proximal Tibia Plating System and accessories are substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
October 26, 2020
Image /page/0/Picture/1 description: The image shows the logo for 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".
Advanced Orthopaedic Solutions, Inc. % Jolie Krance Senior Regulatory Affairs Specialist Advanced Orthopaedic Solutions 3203 Kashiwa Street Torrance, California 90505
Re: K202489
Trade/Device Name: AOS Fibonacci Lower Extremity Plating System - AOS Proximal Tibia Plating 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: August 27, 2020 Received: August 31, 2020
Dear Jolie Krance:
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 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 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, 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) K202489
Device Name
AOS Fibonacci Lower Extremity Plating System - Proximal Tibia Plates
Indications for Use (Describe)
The AOS Fibonacci Proximal Tibia Plating System is intended for the fixation of fractures, malunions, osteopenic bone, and tibial osteotomies of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
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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Image /page/3/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" in a light gray color and the "OS" in a dark blue color. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font.
Traditional 510(k) AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System
510(k) Summary
| Date Prepared | October 22, 2020 |
|---|---|
| Submitted by | Advanced Orthopaedic Solutions, Inc. |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| Phone: (310) 533-9966 | |
| Establishment Registration | 2032480 |
| Owner Operator Number | 9046896 |
| Regulatory Contact | Jolie Krance |
| Regulatory Affairs Manager | |
| Advanced Orthopaedic Solutions, Inc. | |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| (310) 533-9966 | |
| jkrance@aosortho.com | |
| Device Name | AOS Fibonacci Lower Extremity Plating System - AOS Proximal Tibia |
| Plating System | |
| Common Name | Plate, Fixation, Bone |
| Classification | Class 2 |
| 21 CFR 888.3030 | |
| Single/multiple component metallic bone fixation appliances and | |
| accessories | |
| Device Code | HRS - Plate, Fixation, Bone |
| Legally Marketed | |
| Substantially Equivalent | |
| Devices | Synthes LCP Proximal Tibia Plate Line Extension (K052390) (Primary) |
| Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates (K082624) | |
| Referenced Devices | AOS Small Fragment Plating System (K152732) |
| AOS Galileo Trochanteric Nail System (K021008) |
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Image /page/4/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" in blue and the "O" and "S" in a slightly darker shade of blue. The words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller font below the letters.
Device Description The AOS Proximal Tibia Plating System consists of precontoured, single use, open reduction internal fixation Lateral Proximal Tibia Plates and Posteromedial Proximal Tibia Plates, manufactured from titanium alloy, and AOS Fibonacci screws 3.5mm in diameter or larger. These plates and screws, and their dedicated accessories and sterilization trays, will be added to the AOS Fibonacci Lower Extremity Plating System. The 4.0mm Fixed Angle Locking Screws are single use titanium alloy orthopedic fixation screws, designed for use with all plates in the Fibonacci Lower Extremity Plating System, including the proximal tibia plates. The 3.5mm Diamond Workhorse Screws are single use titanium alloy orthopedic fixation screws with a faceted cut core diameter, designed for use with all plates in the Fibonacci Lower Extremity Plating System, including the proximal tibia plates. Indications for Use The AOS Proximal Tibia Plating System is intended to be used for fixation of fractures, nonunions, malunions, osteopenic bone, and tibial osteotomies of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Technological The AOS Proximal Tibia Plating System plates and screws are similar in Characteristics geometry to the identified predicate. The Proximal Tibia Plates have a different material than the identified predicate device (the subject devices is manufactured from titanium alloy, compared to stainless steel or pure titanium), and are compatible with the subject screw with faceted cut core diameter (diamond cut screws). The performance requirements and method of operation of the subject device are identical to the predicate device. Substantial Equivalence The purpose of the Traditional 510(k) is to acquire clearance to market the AOS Proximal Tibia Plating System for inclusion into the AOS Fibonacci Lower Extremity Plating System by claiming substantial equivalence to the legally marketed predicate devices, the Synthes 4.5mm LCP Proximal Tibia Plates (K052390), and the Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates (K082426).
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Image /page/5/Picture/1 description: The image contains the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" in blue, the "O" in gray, and the "S" in blue. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font.
Nonclinical Testing The AOS Proximal Tibia Plating System was subjected to internal engineering analysis, static and fatigue four-point bend testing per ASTM F382, and torsion strength, insertion torque, and pullout strength testing per ASTM F543. The results demonstrate that the AOS Proximal Tibia Plating System and accessories are substantially equivalent to the predicates. Conclusion Since the device has the same intended use and similar technological characteristics to the identified predicates, the device does not raise any different questions of safety or effectiveness. The performance testing and engineering analysis demonstrated that the subject device had substantially equivalent performance. Therefore, the premarket notification demonstrated that the device is substantially equivalent to
the predicate.