DePuy Synthes Femoral Recon Nail System

K172157 · Synthes (USA) Products, LLC · HSB · Nov 14, 2017 · Orthopedic

Device Facts

• Record ID: K172157
• Device Name: DePuy Synthes Femoral Recon Nail System
• Applicant: Synthes (USA) Products, LLC
• Product Code: HSB · Orthopedic
• Decision Date: Nov 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for: - Subtrochanteric fractures - Ipsilateral neck/shaft fractures - Femoral shaft fractures - Impending pathologic fractures - Malunions and nonunions

Device Story

The Femoral Recon Nail (FRN) System consists of titanium alloy intramedullary nails and associated insertion instruments. Designed for stabilization of femoral shaft and neck fractures; implants support both Piriformis Fossa (PF) and Greater Trochanter (GT) entry points. Available in various dimensions and left/right-oriented versions. Used by orthopedic surgeons in clinical/OR settings to fixate fractures; provides mechanical stability to facilitate bone healing. Output is the physical fixation of the femur.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing, including fatigue testing of constructs with standard and recon locking, and analytical evaluation. Endotoxin levels verified via LAL test method (20EU/device).

Technological Characteristics

Intramedullary fixation rod; titanium alloy construction; available in multiple dimensions and left/right orientations; supports Piriformis Fossa and Greater Trochanter entry points; mechanical fixation via locking screws.

Indications for Use

Indicated for adults and adolescents (12-21) with fused growth plates requiring treatment for subtrochanteric, ipsilateral neck/shaft, or femoral shaft fractures, impending pathologic fractures, malunions, or nonunions.

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

• Synthes Lateral Entry Femoral Nail System (K040336)
• Synthes Adolescent Lateral Entry Femoral Nail System (K070843)
• Smith & Nephew Trigen Trochanteric Antegrade Nail (K040462)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 14, 2017

Synthes (USA) Products, LLC Alexander Zwahlen Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

### Re: K172157

Trade/Device Name: DePuy Synthes Femoral Recon Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 17, 2017 Received: October 19, 2017

Dear Mr. Zwahlen:

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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Katherine D. Kavlock -S

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

Enclosure

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

Image /page/2/Picture/0 description: The image shows the logo for DePuy Synthes. The logo consists of a circular symbol on the left and the text "DePuy Synthes" on the right. The circular symbol is made up of several curved lines that form a spherical shape. The text "DePuy Synthes" is written in a sans-serif font, with "DePuy" in a slightly larger font size than "Synthes".

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K172157

Device Name

DePuy Synthes Femoral Recon Nail System

Indications for Use (Describe)

The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for:

- Subtrochanteric fractures

- Ipsilateral neck/shaft fractures

- Femoral shaft fractures

- Impending pathologic fractures

- Malunions and nonunions

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

PSC Publishing Services [phone] EF

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

Image /page/3/Picture/1 description: The image shows the logo for DePuy Synthes. The logo consists of a circular symbol on the left and the text "DePuy Synthes" on the right. The circular symbol is made up of several curved lines that intersect to form a spherical shape, and the text is in a dark blue sans-serif font.

### 6 510(k) Summary

| Sponsor | DePuy Synthes<br>Alexander Zwahlen<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>Phone: [phone]<br>Fax: [phone] |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | July 17, 2017 |
| Proprietary Name | DePuy Synthes Femoral Recon Nail System |
| Classification Name | Rod, Fixation, Intramedullary and Accessories |
| Classification | Class II<br>Regulation Number: 21 CFR 888.3020<br>Product Code: HSB |
| Predicate Devices | Primary Predicate Device:<br>Synthes Lateral Entry Femoral Nail System (K040336)<br>Additional Predicate Device:<br>Synthes Adolescent Lateral Entry Femoral Nail System (K070843)<br>Smith & Nephew Trigen Trochanteric Antegrade Nail (K040462) |
| Device Description | The Femoral Recon Nail (FRN) System is comprised of intramedullary nailing<br>implants designed to provide stabilization of femoral shaft and neck fractures as well<br>as system specific insertion instruments. The Femoral Recon Nail System offers<br>nailing implants in two different designs which enable a Piriformis Fossa (PF) and a<br>Greater Trochanter (GT) entry point for the insertion of the nailing implant in the<br>femur.<br>The implants are manufactured from Titanium alloy, are provided in a range of<br>dimensions and in Left and Right-oriented versions. |
| Indications for use | The Femoral Recon Nail System is intended for treatment of fractures in adults and<br>adolescents (12-21) in which the growth plates have fused. Specifically, the system<br>is indicated for:<br>- Subtrochanteric fractures<br>- Ipsilateral neck/shaft fractures<br>- Femoral shaft fractures<br>- Impending pathologic fractures<br>- Malunions and nonunions |
| Non-clinical<br>Performance Data | Fatigue testing of constructs with standard locking and recon locking as well as an<br>analytical evaluation has been performed to compare the subject device DePuy<br>Synthes Femoral Recon Nail System to the primary predicate device Synthes Lateral<br>Entry Femoral Nail System. This information supports that the mechanical<br>performance of the subject device is at least equivalent to that of the predicate<br>device.<br><br>The devices also meet the specified endotoxin requirement of 20EU/device using the<br>LAL test method. |
| Clinical<br>Performance Data | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial Equivalence | The proposed device has the same intended use as the predicate devices. The<br>proposed device has similar indications for use, are similar in design, material, and<br>fundamental technology as compared to the predicate devices. |
| | The mechanical testing and analytical evaluation included in this submission<br>demonstrate that: |
| | Any differences in technological characteristics of the predicate devices do not<br>raise any new questions of safety and effectiveness. |
| | The proposed devices are at least as safe and effective as the predicate devices. |
| | It is concluded that the information provided in this submission supports substantial<br>equivalence. |

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

# (1) DePuy Synthes