(21 days)
The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non- unions of the proximal humerus
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.
The provided text describes a medical device, the "AOS Anterolateral Proximal Humeral Plate," which is a metallic bone fixation appliance. The document is a 510(k) premarket notification for modifications being added to the existing system. Crucially, the document explicitly states under the "CLINICAL DATA" section: "There is no clinical data referenced in this special 510(k)."
This means that no clinical study was conducted as part of this specific 510(k) submission to prove the device meets acceptance criteria. The claim of substantial equivalence for the modifications (adding 16 and 18-hole plates) is based on similarities to predicate devices and preclinical testing (though the document states mechanical testing was not necessary due to no anticipated decrease in strength or increase in risk).
Therefore, I cannot provide information on acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for this specific submission because the document explicitly states no clinical data was referenced.
The relevant information is:
- Acceptance Criteria and Reported Device Performance: Not applicable, as no clinical study was referenced for this submission. The submission relies on substantial equivalence to predicate devices and the absence of a need for new mechanical testing for the additions.
- Sample size for test set and data provenance: Not applicable, as no clinical study was referenced.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No, not applicable.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as no clinical study was referenced.
- How the ground truth for the training set was established: Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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) |
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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 StreetTorrance, CA 90505Phone: (310) 533-9966Establishment Registration #: 2032480Owner Operator Number: 9046896 |
| CONTACT PERSON: | Alex BhaskarlaAdvanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505Phone: (310) 533-9966 |
| DEVICE NAME: | AOS Anterolateral Proximal Humeral Plate |
| COMMON NAME: | Appliance, Fixation, Nail/Blade/Plate Combination, SingleComponent |
| CLASSIFICATION: | Class II, 21 CFR 888.3030 Single/multiple component metallicbone fixation appliances and accessories |
| DEVICE CODE: | KTW |
| SUBSTANTIALLYEQUIVALENT 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 openreduction internal fixation devices for the temporary fixation ofvarious types of fractures of the humerus and are intended as loadsharing devices which may be removed once the fracture hashealed. The AOS Anterolateral Proximal Humeral System consistsof titanium plates, and proximal and distal locking and non-lockingscrews. 16 and 18 hole plates are being added to the system. The16 hole plates are 9.4 inches long. The 18 hole plates are 10.4inches long. |
| INDICATIONS FOR USE: | The AOS Anterolateral Proximal Humeral Plate is indicated forfractures, fracture dislocations, osteotomies, and non-unions ofthe proximal humerus. |
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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).
§ 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.