(21 days)
No
The device description and performance studies focus on mechanical properties and fixation, with no mention of AI/ML terms or functionalities.
No
This device is an orthopedic plate used for the temporary fixation of bone fractures, which is a structural support function, not a therapeutic one that directly treats or cures a disease or condition. It assists the body's natural healing process rather than providing therapy itself.
No
Explanation: This device is an orthopedic implant for fixing fractures, not for diagnosing medical conditions.
No
The device description explicitly states it consists of titanium plates and screws, which are hardware components for internal fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "fractures, fracture dislocations, osteotomies, and non- unions of the proximal humerus." This describes a surgical implant used to fix bones, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a "open reduction internal fixation device" consisting of plates and screws made of titanium. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information based on those measurements
This device is a surgical implant used for internal fixation of bone fractures.
N/A
Intended Use / Indications for Use
The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus
Product codes
KTW
Device Description
The AOS Anterolateral Proximal Humeral plates are open reduction internal fixation devices for the temporary fixation of various types of fractures of the humerus and are intended as load sharing devices which may be removed once the fracture has healed. The AOS Anterolateral Proximal Humeral System consists of titanium plates, and proximal and distal locking and non-locking screws. 16 and 18 hole plates are being added to the system. The 16 hole plates are 9.4 inches long. The 18 hole plates are 10.4 inches long.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus
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 16 and 18 hole plate additions to the Anterolateral Proximal Humeral Plate System do not present any decreases in strength, increases in risk, or additional safety risks thus mechanical testing is not necessary.
CLINICAL DATA: 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Orthopaedic Solutions, Incorporated Mr. Alex Bhaskarla Regulatory Affairs Manager 3203 Kashiwa Street Torrance, California 90505
June 22, 2017
Re: K171606
Trade/Device Name: AOS Anterolateral Proximal Humeral Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTW Dated: June 1, 2017 Received: June 1, 2017
Dear Mr. 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. 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
1
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 the quality systems (QS) 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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number ( if known ) | K171606 |
| Device Name | AOS Anterolateral Proximal Humeral Plate |
| Indications for Use ( Describe ) | The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non- unions of the proximal humerus |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (8/14) Page 1 of 1
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Section 5 Special 510(k) Summary
| DATE PREPARED: | May 22, 2017 |
|---|---|
| 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 Anterolateral Proximal Humeral Plate |
| COMMON NAME: | Appliance, Fixation, Nail/Blade/Plate Combination, Single |
| Component | |
| CLASSIFICATION: | Class II, 21 CFR 888.3030 Single/multiple component metallic |
| bone fixation appliances and accessories | |
| DEVICE CODE: | KTW |
| SUBSTANTIALLY | |
| EQUIVALENT DEVICES: | Primary: AOS Anterolateral Proximal Humeral Plate |
| (510k): K160409 Cleared March 15, 2016 | |
| Secondary: Synthes (USA) LCP Proximal Humerus Plates | |
| (Philos), Long (510k): K041860 Cleared September 8, 2004 | |
| DEVICE DESCRIPTION: | The AOS Anterolateral Proximal Humeral plates are open |
| reduction internal fixation devices for the temporary fixation of | |
| various types of fractures of the humerus and are intended as load | |
| sharing devices which may be removed once the fracture has | |
| healed. The AOS Anterolateral Proximal Humeral System consists | |
| of titanium plates, and proximal and distal locking and non-locking | |
| screws. 16 and 18 hole plates are being added to the system. The | |
| 16 hole plates are 9.4 inches long. The 18 hole plates are 10.4 | |
| inches long. | |
| INDICATIONS FOR USE: | The AOS Anterolateral Proximal Humeral Plate is indicated for |
| fractures, fracture dislocations, osteotomies, and non-unions of | |
| the proximal humerus. |
4
Section 5 Special 510(k) Summary continued
PREDICATE COMPARISON:
The AOS Anterolateral Proximal Humeral 16 and 18 hole plates have the following similarities to the predicates:
- same device classification ●
- same material ●
- same anatomical sites ●
- . same intended use
- same biocompatibility
- same shaft width
- same locking screw hole diameters
SUBSTANTIAL EQUIVALENCE: The proposed system has the same indications for use, is similar in shape and design, and has the same fundamental technology. Information presented supports substantial equivalence for modifications to the AOS Anterolateral Proximal Humeral Plate to the predicate devices.
PRECLINICAL TESTING: The 16 and 18 hole plate additions to the Anterolateral Proximal Humeral Plate System do not present any decreases in strength, increases in risk, or additional safety risks thus mechanical testing is not necessary. STANDARDS: Recognized industry standards are cited in the Standards Report.
- CLINICAL DATA: There is no clinical data referenced in this special 510(k).