(50 days)
No
The device description and performance studies focus on mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
No.
This device is for fixation of fractures and fusions, primarily providing structural support rather than actively treating a disease or condition in a therapeutic manner.
No
The device description indicates it is a plating system with screws for fixation of fractures, not for diagnosing medical conditions.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the AOS Calcaneal Plating System is a system of titanium plates and screws intended for the fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments. This is a surgical implant used directly within the body to provide structural support and stability.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is purely therapeutic and structural.
Therefore, based on the provided information, the AOS Calcaneal Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AOS Calcaneal Plating System is intended for fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Product codes
HRS
Device Description
The AOS Calcaneal Plating System consists of titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments (K161913 cleared November 4h 2016) and non-locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The system includes variable angle locking screws in diameter of 2.7 and 3.5mm. The plate system also 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
small bones and small bone fragments
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 Calcaneal Plating System has the same indication, similar design, and same fundamental technology compared to the AOS Small Fragment Plating System Lite (K181035). A worst case sample with similar cross sectional area to the AOS Calcaneal Plating System was tested in comparative mechanical testing against the Synthes Modular Mini Fragment LCP System per a four-point bend test based on ASTM F382-17. The results demonstrate that the AOS Calcaneal Plating is substantially equivalent to the predicate. An Engineering analysis was used to demonstrate the substantial equivalence to the AOS Small Fragment Plating System Lite.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that 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 Elaine Nguyen Regulatory Specialist 3203 Kashiwa Street Torrance, California 90505
October 30, 2018
Re: K182466
Trade/Device Name: AOS Calcaneal 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: September 7, 2018 Received: September 10, 2018
Dear Elaine Nguyen:
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 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
1
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 medical devices and radiation-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,
Jesse Muir -S 2018.10.30 14:52:02 -04'00"
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name AOS Calcaneal Plating System
Indications for Use (Describe)
The AOS Calcaneal Plating System is intended for fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
| a News of News Children College of Children Comments of Children Comments of Children Comments of Children Station
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|---|---|---|
| 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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K182466 PAGE 1 of 3
Image /page/3/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions (AOS). The logo features the letters "AOS" in a stylized, sans-serif font, with the letters in a blue color. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font, also in blue.
6. TRADITIONAL 510(K) SUMMARY
September 7, 2018 DATE PREPARED: 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: Elaine Nguyen Requlatory Affairs Specialist Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance, CA 90505 Phone: (310) 533-9966 DEVICE NAME: AOS Calcaneal Plate Plate, Fixation, Bone COMMON NAME: Class II, 21 CFR 888.3030 Single/multiple CLASSIFICATION: component metallic bone fixation appliances and accessories HRS DEVICE CODE: SUBSTANTIALLY Synthes One-Third Tubular DCL Plate, K011335 EQUIVALENT DEVICES: Synthes (USA) Modular Mini Fragment LCP, K063049; AOS Small Fragment Plate System Lite, K181035 The AOS Calcaneal Plating System consists of DEVICE DESCRIPTION: titanium plates in various configurations and sizes. The system is compatible with the AOS Small Fragment Plating System Instruments (K161913 cleared November 4h 2016) and non-locking screws in diameters of 2.4mm, 2.7mm, 3.5mm, and 4.0mm. The system includes variable angle locking screws in diameter of 2.7 and 3.5mm. The plate system also includes 3.5mm headless compression screws, 4.0mm cannulated screws, and 4.0mm partially
threaded cannulated screws.
4
| INDICATIONS FOR USE: | The AOS Calcaneal Plating System is intended for
fixation of fractures, osteotomies, nonunions,
replantations, and fusions of small bones and small
bone fragments, particularly in osteopenic bone. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBSTANTIAL EQUIVALENCE: | Information presented supports substantial
equivalence of the AOS Calcaneal 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. |
| BASIS FOR SUBSTANTIAL
EQUIVALENCE: | The AOS Calcaneal Plating System has the following
similarities to the predicates:
• Same device classification
• Same cross sectional area
• Same thickness
• Same hole features |
| PRECLINICAL TESTING: | The AOS Calcaneal Plating System has the same
indication, similar design, and same fundamental
technology compared to the AOS Small Fragment
Plating System Lite (K181035). A worst case sample
with similar cross sectional area to the AOS
Calcaneal Plating System was tested in comparative
mechanical testing against the Synthes Modular Mini
Fragment LCP System per a four-point bend test
based on ASTM F382-17. The results demonstrate
that the AOS Calcaneal Plating is substantially
equivalent to the predicate.
An Engineering analysis was used to demonstrate
the substantial equivalence to the AOS Small
Fragment Plating System Lite. |
| STANDARDS: | Recognized industry standards are cited in the
Standards Report |
| 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 Calcaneal Plating System 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 effectiveness. The |
5
performance testing and engineering analysis demonstrated that the subject device had substantially equivalence performance. Therefore, the premarket notification demonstrated that the device is substantially equivalent to the predicate.