AOS Anterolateral Proximal Humeral Plate

K171606 · Advanced Orthopaedic Solutions, Inc. (Aos) · KTW · Jun 22, 2017 · Orthopedic

Device Facts

• Record ID: K171606
• Device Name: AOS Anterolateral Proximal Humeral Plate
• Applicant: Advanced Orthopaedic Solutions, Inc. (Aos)
• Product Code: KTW · Orthopedic
• Decision Date: Jun 22, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non- unions of the proximal humerus

Device Story

AOS Anterolateral Proximal Humeral Plate is an open reduction internal fixation device for temporary stabilization of proximal humerus fractures; functions as a load-sharing device; removed after fracture healing. System comprises titanium plates and locking/non-locking screws. Used by orthopedic surgeons in clinical/surgical settings. Provides mechanical stability to bone fragments to facilitate healing.

Clinical Evidence

No clinical data.

Technological Characteristics

Metallic bone fixation appliance; titanium construction; locking and non-locking screw fixation; plate-and-screw system; load-sharing design. 16-hole (9.4 inch) and 18-hole (10.4 inch) configurations.

Indications for Use

Indicated for patients with fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Regulatory Classification

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.

Predicate Devices

• AOS Anterolateral Proximal Humeral Plate (K160409)
• Synthes (USA) LCP Proximal Humerus Plates (Philos), Long (K041860)

Submission Summary (Full Text)

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## 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

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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 [phone] or [phone] 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 [phone] or [phone] 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 | |
| <b>Indications for Use</b> | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
| 510(k) Number ( <i>if known</i> ) | K171606 |
| Device Name | AOS Anterolateral Proximal Humeral Plate |
| Indications for Use ( <i>Describe</i> ) | The AOS Anterolateral Proximal Humeral Plate is indicated for fractures, fracture dislocations, osteotomies, and non- unions of the proximal humerus |
| Type of Use ( <i>Select one or both, as applicable</i> ) | |
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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## Section 5 Special 510(k) Summary

| DATE PREPARED: | May 22, 2017 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Advanced Orthopaedic Solutions, Inc.<br>3203 Kashiwa Street<br>Torrance, CA 90505<br>Phone: [phone]<br>Establishment Registration #: 2032480<br>Owner Operator Number: 9046896 |
| CONTACT PERSON: | Alex Bhaskarla<br>Advanced Orthopaedic Solutions, Inc.<br>3203 Kashiwa Street<br>Torrance, CA 90505<br>Phone: [phone] |
| DEVICE NAME: | AOS Anterolateral Proximal Humeral Plate |
| COMMON NAME: | Appliance, Fixation, Nail/Blade/Plate Combination, Single<br>Component |
| CLASSIFICATION: | Class II, 21 CFR 888.3030 Single/multiple component metallic<br>bone fixation appliances and accessories |
| DEVICE CODE: | KTW |
| SUBSTANTIALLY<br>EQUIVALENT DEVICES: | Primary: AOS Anterolateral Proximal Humeral Plate<br>(510k): K160409 Cleared March 15, 2016 |
| | Secondary: Synthes (USA) LCP Proximal Humerus Plates<br>(Philos), Long (510k): K041860 Cleared September 8, 2004 |
| DEVICE DESCRIPTION: | The AOS Anterolateral Proximal Humeral plates are open<br>reduction internal fixation devices for the temporary fixation of<br>various types of fractures of the humerus and are intended as load<br>sharing devices which may be removed once the fracture has<br>healed. The AOS Anterolateral Proximal Humeral System consists<br>of titanium plates, and proximal and distal locking and non-locking<br>screws. 16 and 18 hole plates are being added to the system. The<br>16 hole plates are 9.4 inches long. The 18 hole plates are 10.4<br>inches long. |
| INDICATIONS FOR USE: | The AOS Anterolateral Proximal Humeral Plate is indicated for<br>fractures, fracture dislocations, osteotomies, and non-unions of<br>the 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).