AOS Anterolateral Proximal Humeral Plate

K160409 · Advanced Orthopaedic Solutions, Inc. · KTW · Mar 15, 2016 · Orthopedic

Device Facts

• Record ID: K160409
• Device Name: AOS Anterolateral Proximal Humeral Plate
• Applicant: Advanced Orthopaedic Solutions, Inc.
• Product Code: KTW · Orthopedic
• Decision Date: Mar 15, 2016
• 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 fracture dislocations, osteotomies, and nonunions of the proximal humerus.

Device Story

AOS Anterolateral Proximal Humeral Plate is an open reduction internal fixation (ORIF) device for temporary fixation of proximal humerus fractures; functions as a load-sharing device. System comprises titanium plates with proximal and distal locking and non-locking screws. Used by orthopedic surgeons in clinical settings to stabilize bone segments during healing; device removed post-healing. Benefits include structural support for bone alignment and fracture stabilization.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench-level comparison of geometry, design, and material properties against the predicate device.

Technological Characteristics

Metallic bone fixation plate system. Material: Ti-6Al-4V (ASTM F1472). Components: Titanium plates, locking and non-locking screws. Function: Load-sharing internal fixation. Non-software device.

Indications for Use

Indicated for patients with fractures, fracture dislocations, osteotomies, and nonunions 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 Proximal Humeral Plate (K080590)

Submission Summary (Full Text)

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Image /page/0/Picture/1 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, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Advanced Orthopaedic Solutions, Incorporated Kazu Mivahara Product Development Engineer 3203 Kashiwa Street Torrance, California 90505

March 15, 2016

Re: K160409 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: February 16, 2016 Received: February 17, 2016

Dear Kazu Miyahara:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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

510(k) Number (if known) K160409

#### Device Name

AOS Anterolateral Proximal Humeral Plate

Indications for Use (Describe)

The AOS Anterolateral Proximal Humeral Plate is indicated for fracture dislocations, osteotomies, and nonunions of the proximal humerus.

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 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 all in uppercase.

## 8. SPECIAL 510(K) SUMMARY

| SUMMARY PREPARED ON: | March 9, 2016 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Advanced Orthopaedic Solutions, Inc.<br>3203 Kashiwa Street<br>Torrance, CA 90505<br>Phone: [phone] |
| CONTACT PERSON: | Kazu Miyahara<br>Advanced Orthopaedic Solutions, Inc.<br>3203 Kashiwa Street<br>Torrance, CA 90505<br>Phone: [phone] |
| DEVICE NAME:<br>COMMON NAME: | AOS Anterolateral Proximal Humeral Plate<br>Appliance, Fixation, Nail/Blade/Plate Combination,<br>Single Component |
| CLASSIFICATION: | Class II, 21 CFR 888.3030 Single/multiple<br>component metallic bone fixation appliances and<br>accessories |
| DEVICE CODE: | KTW |
| SUBSTANTIALLY<br>EQUIVALENT DEVICE: | AOS Proximal Humeral Plate (K080590, May 6,<br>2008) |
| DEVICE DESCRIPTION: | The AOS Anterolateral Proximal Humeral plates are<br>open reduction internal fixation devices for the<br>temporary fixation of various types of fractures of the<br>humerus and are intended as load sharing devices<br>which may be removed once the fracture has healed.<br>The AOS Anterolateral Proximal Humeral System<br>consists of titanium plates, and proximal and distal<br>locking and non-locking screws. |
| INDICATIONS FOR USE: | The AOS Anterolateral Proximal Humeral Plate is<br>indicated for fractures, fracture dislocations,<br>osteotomies, and non-unions of the proximal<br>humerus. |
| SUBSTANTIAL EQUIVALENCE: | Information presented supports substantial<br>equivalence of the Anterolateral Proximal Humeral<br>plate to the predicate device. The proposed plates<br>have the same indications for use, are similar in<br>geometry and design, have the same fundamental |

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scientific technology, and are made of the same material (Ti-6Al-4V, per ASTM F1472) as the predicate plates. As detailed in the submission, the proposed plates do not present a worst-case scenario with respect to strength characteristics and because of their similarity to the current plates, physical testing was deemed unnecessary, and substantial equivalence was determined in strength and geometry between the proposed plates and predicate plates.