(79 days)
Not Found
No
The summary describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
This device is a therapeutic device because its intended use is for "fixations of fractures, osteotomies, and non-unions," which are treatments for various medical conditions of the bone.
No
The device is described as a plating system intended for fixation of fractures and osteotomies, which is a treatment or repair function, not a diagnostic one.
No
The device description explicitly states it consists of titanium plates and screws, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixations of fractures, osteotomies, and non-unions" of various bones. This is a surgical procedure performed directly on a patient's body.
- Device Description: The device consists of "titanium plates" and "screws," which are implants used in surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device is a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / 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, including osteopenic bone.
Product codes
HRS, HWC, HTN
Device Description
The AOS Small Fragment Plating System consists of titanium plates in various configurations and sizes. The system includes 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, 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
The AOS Small Fragment Plating System was subjected to comparative mechanical testing per a four point bend test based on ASTM F382-14 and a Variable Angle Locking Mechanism test to evaluate the screw-plate interface. The results demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicates.
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
December 10, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Orthopaedic Solutions, Incorporated (AOS) Mr. Mark Steinhauer Product Development Engineer 3203 Kashiwa Street Torrance, California 90505
Re: K152732 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 2, 2015 Received: October 5, 2015
Dear Mr. Steinhauer:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K152732 |
|---|---|
| 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, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, 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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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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 darker shade of 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. The text is aligned to the left.
5. TRADITIONAL 510(K) SUMMARY
| DATE PREPARED: | September 4, 2015 |
|---|---|
| SUBMITTED BY: | Advanced Orthopaedic Solutions, Inc. |
| 3203 Kashiwa Street | |
| Torrance, CA 90505 | |
| Phone: (310) 533-9966 | |
| CONTACT PERSON: | Mark Steinhauer |
| 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. | |
| DEVICE CODE: | HRS, HWC and HTN |
| SUBSTANTIALLY | |
| EQUIVALENT DEVICES: | Synthes Small Fragment Dynamic Compression |
| Locking (DCL) System (510(k): K000684, Cleared | |
| April 28, 2000) and Synthes 2.7mm/3.5mm LCP | |
| Distal Fibula Plates (510(k): K073460, Cleared | |
| February 21, 2008). | |
| DEVICE DESCRIPTION: | The AOS Small Fragment Plating System consists of |
| titanium plates in various configurations and sizes. | |
| The system includes 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 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, | |
| including osteopenic bone. | |
| SUBSTANTIAL EQUIVALENCE: | Information presented supports substantial |
| equivalence of the AOS Small Fragment Plating |
4
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.
- 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 and a Variable Angle Locking Mechanism test to evaluate the screw-plate interface. The results demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicates.