(56 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Type) | Reported Device Performance (Summary) |
|---|---|
| Static Four-Point Bend Testing (per ASTM F382) | Results, alongside other tests, demonstrated substantial equivalence to predicate devices. |
| Fatigue Four-Point Bend Testing (per ASTM F382) | Results, alongside other tests, demonstrated substantial equivalence to predicate devices. |
| Torsion Strength Testing (per ASTM F543) | Results, alongside other tests, demonstrated substantial equivalence to predicate devices. |
| Insertion Torque Testing (per ASTM F543) | Results, alongside other tests, demonstrated substantial equivalence to predicate devices. |
| Pullout Strength Testing (per ASTM F543) | Results, alongside other tests, demonstrated substantial equivalence to predicate devices. |
| Internal Engineering Analysis (Not a specific test) | Contributed to the overall demonstration of substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test. It generally refers to "the AOS Proximal Tibia Plating System" being subjected to various tests. The data provenance is not specified (e.g., country of origin). The testing described is prospective as it was conducted to demonstrate substantial equivalence for a new device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a metallic bone fixation appliance, and the "ground truth" is established through mechanical and engineering performance testing, not through expert human assessment of images or clinical outcomes in the same way an AI diagnostic device would be.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the assessment is based on objective mechanical testing against established standards (ASTM F382, ASTM F543) rather than human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers' performance is being evaluated with and without AI assistance. This document describes a medical device (bone plating system) where performance is assessed through physical and mechanical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device. The document describes the mechanical performance of a physical medical implant.
7. The Type of Ground Truth Used
The "ground truth" in this context is defined by the performance requirements outlined in the referenced ASTM standards (ASTM F382 for static and fatigue bending, and ASTM F543 for torsion, insertion torque, and pullout strength). The performance of the predicate devices, which are legally marketed, also serves as a benchmark for "ground truth" in the substantial equivalence argument.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device and therefore does not have a "training set" in that sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
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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 StreetTorrance, CA 90505Phone: (310) 533-9966 |
| Establishment Registration | 2032480 |
| Owner Operator Number | 9046896 |
| Regulatory Contact | Jolie KranceRegulatory Affairs ManagerAdvanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505(310) 533-9966jkrance@aosortho.com |
| Device Name | AOS Fibonacci Lower Extremity Plating System - AOS Proximal TibiaPlating System |
| Common Name | Plate, Fixation, Bone |
| Classification | Class 221 CFR 888.3030Single/multiple component metallic bone fixation appliances andaccessories |
| Device Code | HRS - Plate, Fixation, Bone |
| Legally MarketedSubstantially EquivalentDevices | 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.
§ 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.