AOS Galileo™ Trochanteric Nail System

K202099 · Advanced Orthopaedic Solutions, Inc. · HSB · Aug 28, 2020 · Orthopedic

Device Facts

• Record ID: K202099
• Device Name: AOS Galileo™ Trochanteric Nail System
• Applicant: Advanced Orthopaedic Solutions, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Aug 28, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AOS Galileo™ Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, peritrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.

Device Story

AOS Galileo™ Trochanteric Nail System is a single-use, cannulated, side-specific femoral intramedullary nail system; includes telescoping lag screws, anti-rotation screw, cortical locking bone screws, and sterilization trays. Designed for open reduction and internal fixation of femoral fractures; enters through greater trochanter. Functions as load-sharing device; removed after fracture healing. Used by orthopedic surgeons in clinical/surgical settings. Provides mechanical stabilization of bone fragments to facilitate healing.

Clinical Evidence

Bench testing only. Functional testing and strength comparison analysis performed to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Cannulated, side-specific femoral intramedullary nail system. Includes telescoping lag screws, anti-rotation screw, and cortical locking bone screws. Single-use. Mechanical fixation device.

Indications for Use

Indicated for stable/unstable proximal femoral fractures (peritrochanteric, intertrochanteric, high subtrochanteric, combinations). Long nail indicated for subtrochanteric fractures, shaft fractures, pathologic fractures (prophylactic use) in osteoporotic bone, ipsilateral femoral fractures, non-unions, malunions, and revision procedures.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• AOS Galileo™ Trochanteric Nail System - Lag Screw (K120148)
• AOS Galileo™ Trochanteric Nail System (K021008)
• AOS Galileo™ Trochanteric Nail System - ES Nail (K103533)

Submission Summary (Full Text)

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August 28, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

Advanced Orthopaedic Solutions, Inc. Jolie Krance Senior Regulatory Affairs Specialist 3203 Kashiwa Street Torrance, California 90505

## Re: K202099

Trade/Device Name: AOS Galileo™ Trochanteric Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 29, 2020 Received: July 30, 2020

## Dear Jolie Krance:

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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Special 510(k) Summary

| Date Prepared | August 21, 2020 |
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| Submitted by | Advanced Orthopaedic Solutions, Inc<br>3203 Kashiwa Street<br>Torrance, CA 90505<br>Phone: [phone] |
| Establishment Registration | 2032480 |
| Owner Operator Number | 9046896 |
| Regulatory Contact | Jolie Krance<br>Senior Regulatory Affairs Specialist<br>Advanced Orthopaedic Solutions, Inc.<br>3203 Kashiwa Street<br>Torrance, CA 90505<br>[phone]<br>[e-mail] |
| Device Name | AOS Galileo™ Trochanteric Nail System |
| Common Name | Trochanteric Intermedullary Nail System |
| Classification | Class II, 21 CFR 888.3020 Intramedullary Fixation Rod |
| Device Code | HSB — Rod, Fixation, Intramedullary and Accessories |
| AOS Legally Marketed<br>Substantially Equivalent<br>Devices | Primary — AOS Galileo™ Trochanteric Nail System - Lag Screw<br>(K120148, Cleared October 2, 2012)<br><br>Additional — AOS Galileo™ Trochanteric Nail System (K021008,<br>Cleared June 20, 2002), and AOS Galileo™ Trochanteric Nail System -<br>ES Nail (K103533, Cleared January 19, 2011) |
| Device Description | The AOS Galileo™ Trochanteric Nail System is a single-use, open<br>reduction and internal fixation device, comprised of the Trochanteric<br>Intermedullary Nail, Telescoping Lag Screws, Anti Rotation Screw,<br>Cortical Locking Bone Screws, and their dedicated accessories, and<br>sterilization trays. The trochanteric nail is a side specific cannulated<br>femoral intramedullary nail with a proximal bend that is designed to<br>enter through the greater trochanter, for the treatment of fractures to<br>the femur, including peritrochanteric, intertrochanteric, high<br>subtrochanteric fractures, and combinations thereof. The device is<br>meant to be used as a load sharing device, and it may be removed<br>once the fracture is healed. |
| Indications for Use | The AOS Galileo™ Trochanteric Nail System is intended to treat stable<br>and unstable proximal fractures of the femur including<br>peritrochanteric, intertrochanteric and high subtrochanteric fractures<br>and combinations of these fractures. The long trochanteric nail is<br>additionally indicated for subtrochanteric fractures, peritrochanteric<br>fractures associated with shaft fractures, pathologic fractures<br>(including prophylactic use) in osteoporotic bone of the trochanteric<br>and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral<br>fractures, proximal and distal non-unions and malunions and revisions<br>procedures. |
| Technological<br>Characteristics | The AOS Galileo Trochanteric Nail System subject device has similar<br>technological charateristics to the identified predicates. The material<br>and chemical composition, performance requirements, and method of<br>operation are identical to the predicate devices. |

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Image /page/4/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" and "O" in blue and the "S" in gray. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.

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Image /page/5/Picture/1 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, the "O" in blue, and the "S" in gray. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font. The text is aligned to the left.

| Substantial Equivalence | The subject AOS Galileo™ Trochanteric Nail System, the predicates<br>AOS Galileo™ Lag Screw (K120148) AOS Galileo™ Trochanteric Nail<br>System (K021008), and the AOS Galileo™ Trochanteric ES Nail<br>(K103533), have the same intended use, patient population, operating<br>principle, and risk profile. They have identical manufacturing,<br>packaging, sterilization parameters, and shipping processes, all of<br>which will be conducted under the same quality management system. |
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| Nonclinical Testing | The AOS Galileo™ Trochanteric Nail System was subjected to<br>functional testing and strength comparison analysis. The results<br>demonstrate that the Galileo™ Intramedullary Nails and accessories<br>are substantially equivalent to the predicates. |
| Conclusion | Since the device has the same intended use and similar technological<br>characteristics to the identified predicates, the device does not raise<br>any different questions of safety or effectiveness. The performance<br>testing and engineering analysis demonstrated that the subject device<br>had substantially equivalence performance. Therefore, the premarket<br>notification demonstrated that the device is substantially equivalent to<br>the predicate |