(115 days)
Not Found
No
The device description and performance studies focus on mechanical properties of titanium plates, screws, and washers, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is used for fixation of fractures and non-unions, which is a structural or supportive function, not a therapeutic one that directly treats a disease or condition.
No
Explanation: The device description states it consists of titanium plates, screws, and washers for fixations of fractures and non-unions, indicating it is an orthopedic implant system and not a diagnostic device.
No
The device description explicitly states it consists of titanium plates, screws, and washers, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures and non-unions of various bones. This is a surgical procedure performed on the patient's body.
- Device Description: The device consists of implants (plates, screws, washers, wires) designed to be surgically inserted into the body to stabilize bone.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not perform any such analysis.
The AOS Small Fragment Plating System is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The AOS Small Fragment Plating System is intended to be used for fixations of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
Product codes
HRS, HWC, HTN
Device Description
The AOS Small Fragment Plating System consists of titanium plates, screws, and washers in various configurations and sizes. The system includes Kirschner wires, non-locking screws in diameters of 2.7mm, 3.5mm, and 4.0mm. The system includes variable angle locking screws in diameters of 2.7mm, and 3.5mm. The plate system includes 3.5mm headless compression screws, 4.0mm cannulated screws, and 4.0mm partially threaded cannulated 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, fibula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
The AOS Small Fragment Plating System was subjected to comparative mechanical testing per a four point bend test based on ASTM F382-14. The results demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicate.
There is no clinical data referenced in this special 510(k).
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Orthopaedic Solutions, Inc. (AOS) Alex Bhaskarla Regulatory Affairs Manager 3203 Kashiwa Street Torrance, California 90505
November 4, 2016
Re: K161913 Trade/Device Name: AOS Small Fragment 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, HWC, HTN Dated: October 12, 2016 Received: October 14, 2016
Dear Mr. 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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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) K161913
Device Name
AOS Small Fragment Plating System
Indications for Use (Describe)
The AOS Small Fragment Plating System is intended to be used for fixations of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
| 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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Image /page/3/Picture/0 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 lighter color than the "OS". Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The overall design is clean and professional.
4. Special 510(K) SUMMARY
| DATE PREPARED: | June 13, 2015 |
|---|---|
| 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 |
| Advanced Orthopaedic Solutions, Inc. | |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| Phone: (310) 533-9966 | |
| DEVICE NAME: | AOS Small Fragment Plating System |
| COMMON NAME: | Small Fragment Plate |
| CLASSIFICATION: | Class II, 21 CFR 888.3030 Single/multiple component metallic bone |
| fixation appliances and accessories and 21 CFR 888.3040 | |
| Smooth/threaded metallic bone fixation fastener. | |
| No performance standards have been established under Section 514 of | |
| the Food, Drug and Cosmetic Act for small fragment plates. | |
| DEVICE CODE: | HRS, HWC, HTN |
| SUBSTANTIALLY | |
| EQUIVALENT DEVICES: | AOS Small Fragment Plating System |
| (510k):K152732 Cleared December 10, 2015 | |
| DEVICE DESCRIPTION: | The AOS Small Fragment Plating System consists of titanium plates, |
| screws, and washers in various configurations and sizes. The system | |
| includes Kirschner wires, non-locking screws in diameters of 2.7mm, | |
| 3.5mm, and 4.0mm. The system includes variable angle locking screws in | |
| diameters of 2.7mm, and 3.5mm. The plate system includes 3.5mm | |
| headless compression screws, 4.0mm cannulated screws, and 4.0mm | |
| partially threaded cannulated screws. | |
| INDICATIONS FOR USE: | The AOS Small Fragment Plating System is intended to be used for |
| fixations of fractures, osteotomies, and non-unions of the clavicle, | |
| scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, | |
| particularly in osteopenic bone. | |
| SUBSTANTIAL EQUIVALENCE: | Information presented supports substantial equivalence for modifications |
| to the AOS Small Fragment Plating System to the predicate devices. The | |
| proposed system has the same indications for use, is similar in shape and | |
| design, and has the same fundamental technology. |
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Image /page/4/Picture/0 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 and the "O" and "S" in a lighter shade of blue. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font.
| BASIS FOR SUBSTANTIAL
| EQUIVALENCE: | The modification to AOS Small Fragment Plating System has the following similarities to the AOS Small Fragment Plating System (K152732): same intended usesame indications for usesame raw materialsame method of manufacturesame designsimilar sizes and dimensionssame type of interfacesame shelf lifesame biocompatibilitysame sterilizationsame packing methodssame physical limitations The modified AOS Small Fragment Plating System has longer and shorter plates, shorter screws, and screw cannulation. |
|---|---|
| PRECLINICAL TESTING: | The AOS Small Fragment Plating System was subjected to comparative mechanical testing per a four point bend test based on ASTM F382-14. The results demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicate. |
| STANDARDS: | Recognized industry standards are cited in the Standards Report |
| CLINICAL DATA: | There is no clinical data referenced in this special 510(k) |