(128 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of titanium plates and screws for fracture fixation, with no mention of AI or ML.
Yes
This device is intended for the fixation of fractures and nonunions of bones, which is a therapeutic purpose.
No
The device is a plating system intended for fracture fixation, which is a treatment, not a diagnostic, function.
No
The device description explicitly states it consists of titanium plates and is compatible with instruments and screws, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixations of fractures, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, and or fibula, including osteopenic bone." This describes a surgical implant used to stabilize bones, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details titanium plates and screws, which are physical implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The AOS Small Fragment Plating System Lite is intended to be used for fixations of fractures, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, and or fibula, including osteopenic bone.
Product codes
HRS
Device Description
The AOS Small Fragment Plating System Lite consists of titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments and non-locking and variable angle locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The plate system also includes 3.5mm headless compression screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and/or fibula
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
PRECLINICAL TESTING: The AOS Small Fragment Plating System Lite device was found to have substantially equivalent bending strength and bending stiffness because of ASTM F382 Static and dynamic four-point bend testing and Engineering analysis. An engineering analysis was used to demonstrate the subject screws have substantially equivalent performance in torsional strength, bending strength and axial pullout strength.
CLINICAL DATA: There is no clinical data referenced in this 510(k)
PERFORMANCE TESTING No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the AOS Small Fragment Plating System Lite plates was conducted in accordance with various international standards and internal AOS methods.
Key Metrics
Not Found
Predicate Device(s)
Synthes One Third Tubular Plate K011335, Small Fragment Dynamic Compression Locking (DCL) System K000684, AOS Small Fragment Plating System K161913
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 two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Advanced Orthopaedic Solutions, Inc. (AOS) Alex Bhaskarla Regulatory Affairs Manager 3203 Kashiwa Street Torrance, California 90505
August 24, 2018
Re: K181035
Trade/Device Name: AOS Small Fragment Plating System Lite 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: July 18, 2018 Received: July 24, 2018
Dear Alex Bhaskarla:
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181035
Device Name
AOS Small Fragment Plating System Lite
Indications for Use (Describe)
The AOS Small Fragment Plating System Lite is intended to be used for fixations of fractures, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, and or fibula, including osteopenic bone.
| 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 gray and the "OS" in blue. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The text is all in uppercase.
6. TRADITIONAL 510(K) SUMMARY
| DATE PREPARED: | October 5, 2017 by Alex Bhaskarla |
|---|---|
| SUBMITTED BY: | Advanced Orthopaedic Solutions, Inc. |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| Phone: (310) 533-9966 | |
| Establishment Registration #: 2032480 | |
| Owner Operator Number: 9046896 | |
| CONTACT PERSON: | Alex Bhaskarla |
| Regulatory Affairs Manager | |
| Advanced Orthopaedic Solutions, Inc. | |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| Phone: (310) 533-9966 | |
| DEVICE NAME: | AOS Small Fragment Plating System Lite |
| COMMON NAME: | Plate, Fixation, Bone |
| CLASSIFICATION: | Class II, 21 CFR 888.3030 Single/multiple |
| component metallic bone fixation appliances and | |
| accessories | |
| DEVICE CODE: | HRS |
| PREDICATE DEVICES: | Primary: Synthes One Third Tubular Plate K011335 |
| Additional Predicates: | |
| Small Fragment Dynamic Compression Locking | |
| (DCL) System K000684 | |
| AOS Small Fragment Plating System K161913 |
4
| DEVICE DESCRIPTION: | The AOS Small Fragment Plating System Lite consists of titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments and non-locking and variable angle locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The plate system also includes 3.5mm headless compression screws. |
|---|---|
| INDICATIONS FOR USE: | The AOS Small Fragment Plating System Lite is intended to be used for fixations of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and/or fibula, including osteopenic bone. |
| TECHNOLOGY COMPARISON: | Information presented supports substantial equivalence of the AOS Small Fragment Plating System Lite to the predicate device. The proposed system has the same indications for use, is similar in shape and design, and has the same fundamental technology. |
| The AOS Small Fragment Plating System Lite has the following similarities to the predicate: Same device classificationSame low profile featureWithin length range of platesWithin Diameter range of screws |
Differences include hole configurations and width.
PRECLINICAL TESTING: The AOS Small Fragment Plating System Lite device was found to have substantially equivalent bending strength and bending stiffness because of ASTM F382 Static and dynamic four-point bend testing and Engineering analysis.
An engineering analysis was used to demonstrate the subject screws have substantially equivalent performance in torsional strength, bending strength and axial pullout strength.
5
| CLINICAL DATA: | There is no clinical data referenced in this 510(k) |
|---|---|
| PERFORMANCE TESTING | No performance standards applicable to this device |
| have been adopted under Section 514 of the Food, | |
| Drug and Cosmetic Act. Performance testing of the | |
| AOS Small Fragment Plating System Lite plates was | |
| conducted in accordance with various international | |
| standards and internal AOS methods. | |
| 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 effectivness. | |
| 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. |