FLOW-NAIL

K140601 · Flow-Fx, LLC · HSB · Jul 2, 2014 · Orthopedic

Device Facts

• Record ID: K140601
• Device Name: FLOW-NAIL
• Applicant: Flow-Fx, LLC
• Product Code: HSB · Orthopedic
• Decision Date: Jul 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.

Device Story

Flow-Nail is a dynamic compression trochanteric nail system for orthopedic fracture fixation. System components include intramedullary nail, sliding fenestrated lag screw, anti-rotation screws, and cap. Device is used in surgical settings by orthopedic surgeons to stabilize proximal femoral fractures; additionally functions as a conduit for delivery of injectable bone void fillers (BVF) to the surgical site. Mechanical fixation is achieved via standard intramedullary nailing techniques. Clinical benefit includes stabilization of fractures and potential for localized bone void augmentation. Device is manufactured from titanium alloy.

Clinical Evidence

Bench testing only. Mechanical performance demonstrated via static and dynamic compression bending load testing. BVF delivery capability validated through injectability testing, experimental void fill imaging studies, and static extraction torque testing.

Technological Characteristics

Titanium alloy (Ti-6Al-4V) per ASTM F136. System includes intramedullary nail, sliding fenestrated lag screw, anti-rotation screws, and cap. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for patients with stable or unstable proximal femoral fractures, including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations thereof. Also indicated for delivery of injectable bone void fillers to the surgical site.

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

• Zimmer Natural Nail System (K120715 and K091566)
• Stryker Gamma 3 Nail System (K032244)
• AOS Trochanteric Nail (K103533 and K021008)

Reference Devices

• ETEX Beta-bsm (K062630, K072355, K090242, K101557)
• CarriGen (K062630, K072355, K090242, K101557)

Submission Summary (Full Text)

{0}------------------------------------------------

K140601 Page 1 of 2

| | 510(k) Summary | JUL 02 2014 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Trade Name: | Flow-Nail | |
| Manufacturer: | Flow-FX, LLC<br>19110 Darvin Drive<br>Mokena, Illinois 60448<br>708.390.2290 | |
| Prepared by: | Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>202.552.5800 | |
| Date Prepared: | June 4, 2014 | |
| Common Name: | Intramedullary Fixation Rod | |
| Classification: | 21 CFR 888.3020 | |
| Class: | II | |
| Product Code: | HSB | |

### Indications for Use:

The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.

## Device Description:

The Flow-Nail is a dynamic compression trochanteric nail system and includes an intramedullary nail, a sliding fenestrated lag screw, anti-rotation screws, a cap and accompanying surgical instruments. The Flow-Nail components are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136.

# Predicate Devices:

The Flow-Nail was shown to be substantially equivalent to the Zimmer Natural Nail System (K120715 and K091566), Stryker Gamma 3 Nail System (K032244), and AOS Trochanteric Nail (K103533 and K021008). The Flow-Nail is compatible for use with injectable BVFs.

{1}------------------------------------------------

## Substantial Equivalence:

The table below summarizes the substantial equivalence of the Flow-Nail to predicate devices with respect to its intended use, design, materials, available sizes, mechanical performance, and ability to deliver BVF to a defect site.

| | Subject Device | Predicates | | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Flow-Nail | Zimmer Natural Nail | Stryker Gamma 3 Nail<br>System | AOS Trochanteric<br>Nail System<br>(K021008) |
| Intended Use | Intended for temporary fracture fixation and stabilization of the bone. | | | |
| Indications<br>for Use | The FlowNail is<br>intended to treat stable<br>and unstable proximal<br>fractures of the femur<br>including<br>pertrochanteric,<br>intertrochanteric, and<br>high subtrochanteric<br>fractures and<br>combinations of these<br>fractures. The Flow-<br>Nail can also be used to<br>deliver injectable bone<br>void fillers to a surgical<br>site. | Indications for the use<br>of the Cephalomedullary<br>nails include:<br>- Compound and simple<br>shaft fractures<br>- Proximal, metaphyseal<br>and distal shaft<br>fractures<br>- Segmental fractures<br>- Comminuted fractures<br>- Fractures involving<br>osteopenic and<br>osteoporotic bone<br>- Pathological fractures<br>- Fractures with bone<br>loss<br>- Pseudoarthrosis, non-<br>union, mal-union and<br>delayed union<br>- Periprosthetic fractures<br>- Surgically created<br>defects such as<br>osteotomies<br>- Intertrochanteric and<br>subtrochanteric<br>fractures | The intended use of the<br>subject Trochanteric<br>Gamma 3 Nail is identical<br>to that of the predicate<br>Trochanteric Dyax and<br>Gamma Nails. The<br>product is intended for use<br>in stabilizing various types<br>of intertrochanteric<br>fractures of the femur. | The AOS Trochanteric<br>Nail is intended to treat<br>stable and unstable<br>proximal fractures of<br>the femur including<br>pertrochanteric,<br>intertrochanteric, and<br>high subtrochanteric<br>fractures and<br>combinations of these<br>fractures. |
| Components | IM Nail; Lag Screw | IM Nail; Lag Screw | IM Nail; Lag Screw | IM Nail; Lag Screw |
| Materials | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Nail Sizes | Within predicate<br>range | A range of sizes to<br>accommodate various<br>patient anatomies | A range of sizes to<br>accommodate various<br>patient anatomies | A range of sizes to<br>accommodate<br>various patient<br>anatomies |
| Lag Screw<br>Sizes | Within predicate<br>range | A range of lengths to<br>accommodate various<br>patient anatomies | A range of lengths to<br>accommodate various<br>patient anatomies | A range of lengths to<br>accommodate<br>various patient<br>anatomies |
| Mechanical<br>Performance | Mechanical testing demonstrates the substantial equivalence of the Flow-Nail relative to the<br>identified predicates when subjected to static and dynamic compression bending loads. | | | |
| BVF<br>Delivery | Yes | No | No | No |
| BVF<br>Delivery<br>System | The qualification testing (i.e., Injectability Testing, Experimental Void Fill Imaging Studies,<br>Static Extraction Torque, BVF Property characterization), was performed with ETEX Beta-bsm<br>and CarriGen (K062630, K072355, K090242, K101557). | | | |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is centered and appears to be the title or heading of a document or organization. The font is simple and clear, making the text easily readable.

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

July 2, 2014

Flow-FX. LLC % Ms. Michelle McDonough Senior Associate, Regulatory and Clinical Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005

Re: K140601

Trade/Device Name: Flow-Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 4, 2014 Received: June 5, 2014

Dear Ms. McDonough:

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

{3}------------------------------------------------

Page 2 - Ms. Michelle McDonough

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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" (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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Laurence D. Coyne -A

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### 4. Indications for Use

K140601 510(k) Number (if known):

Device Name: Flow-Nail

The Flow-Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric. intertrochanteric. and high subtrochanteric fractures and combinations of these fractures. The Flow-Nail can also be used to deliver injectable bone void fillers to a surgical site.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

in the color control contrôlean comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

---

Division of Orthopedic Devices

page 1/1