INTRAMEDULLARY NAIL AND SCREWS-NEONAIL

K141103 · Neoortho Produtos Ortopedicos S/A · HSB · Sep 23, 2014 · Orthopedic

Device Facts

• Record ID: K141103
• Device Name: INTRAMEDULLARY NAIL AND SCREWS-NEONAIL
• Applicant: Neoortho Produtos Ortopedicos S/A
• Product Code: HSB · Orthopedic
• Decision Date: Sep 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intramedullary Nail and Screws for Femur – NEONAIL is indicated for femoral fracture fixation including: - Open and closed femoral fractures; - Pseudoarthrosis and correction osteotomy; - Pathologic fractures, impending pathologic fractures, and tumor resections; - Ipsilateral femur fractures; - Fractures distal to the hip joint; and - Nonunions and malunions. Intramedullary Nail and Screws for Tibia – NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions of the tibia. Intramedullary Nail and Screws for Tibia – NEONAIL is indicated for tibial fracture fixation, which may include: - Open and closed tibial fractures: - Pseudoarthodlosis and correction osteotomy; - Pathologic fractures, impending pathologic fractures and tumor resections; and - Nonunions and malunions. The Intramedullary Nail and Screws for Humerus – NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.

Device Story

Intramedullary Nail and Screws - NEONAIL consists of cannulated metal rods, bone screws, and end caps; implanted into medullary cavity of long bones (femur, tibia, humerus) to treat fractures. Device provides internal fixation/stabilization of bone segments. Used by orthopedic surgeons in clinical/surgical settings. Rods feature screw holes for various screw diameters/lengths to accommodate specific anatomic locations and fracture configurations. Benefit: provides mechanical stability to facilitate bone healing. Output is physical stabilization of the fracture site.

Clinical Evidence

No clinical data submitted. Substantial equivalence demonstrated via bench testing, including engineering analysis, dimensional analysis, and mechanical performance testing (static four-point bending, static torsion, bending fatigue, torsional properties, driving torque, and axial pullout strength).

Technological Characteristics

Materials: Ti-6Al-4V alloy. Components: Cannulated rods, bone screws, end caps. Testing standards: ASTM F1264 (intramedullary fixation devices), ASTM F543 (metallic bone screws). Mechanical testing: Static four-point bending, torsion, fatigue, axial pullout, driving torque. No software or electronic components.

Indications for Use

Indicated for patients requiring fixation or temporary stabilization of femoral, tibial, or humeral fractures, including open/closed fractures, pseudoarthrosis, correction osteotomy, pathologic/impending pathologic fractures, tumor resections, ipsilateral femur fractures, fractures distal to the hip, nonunions, malunions, and malalignments.

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

• T2 Femoral Nail (K010801)
• T2 Femoral Nail Model 1825-XXXXCP, 1828-XXXXCP (K112059)
• T2 Tibial Nailing System (K131365)
• T2 Proximal Humeral Nail (K042396)
• T2 Nailing System (K032523)

Submission Summary (Full Text)

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

September 23, 2014

NEOORTHO Produtos Ortopédicos S/A % Mr. Kevin A. Thomas, PhD PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130

Re: K141103

Trade/Device Name: Intramedullary Nail and Screws - NEONAIL Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: August 28, 2014 Received: August 28, 2014

Dear Dr. Thomas:

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

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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/Resourcesfor You/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 vours.

# Lori A. Wiggins -S

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

Enclosure

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## Indications for Use

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

Page

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#### 510(k) Number (if known) K141103

#### Device Name

Intramedullary Nail and Screws - NEONAIL

#### Indications for Use (Describe)

Intramedullary Nail and Screws for Femur - NEONAIL is indicated for femoral fracture fixation including:

- · Open and closed femoral fractures;
- · Pseudoarthrosis and correction osteotomy;
- · Pathologic fractures, impending pathologic fractures, and tumor resections;
- · Ipsilateral femur fractures;
- · Fractures distal to the hip joint; and
- Nonunions and malunions.

Intramedullary Nail and Screws for Tibia - NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions or nonunions of the tibia. Intramedullary Nail and Screws for Tibia - NEONAIL is indicated for tibial fracture fixation, which may include:

- · Open and closed tibial fractures;
- · Pseudoarthodlosis and correction osteotomy;
- · Pathologic fractures, impending pathologic fractures and tumor resections; and
- · Nonunions and malunions.

The Intramedullary Nail and Screws for Humerus – NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.

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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# 510(k) Summary NEOORTHO Produtos Ortopédicos S/A Intramedullary Nail and Screws – NEONAIL K141103

September 18, 2014

## ADMINISTRATIVE INFORMATION

| Manufacturer Name | NEOORTHO Produtos Ortopédicos S/A<br>Rua Ângelo Domingos Durigan, 607, Cascatinha<br>Curitiba, Paraná 82025-100, Brazil | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------|
| | Telephone: | [phone] |
| | Fax: | [phone] |
| Official Contact | Mariana de Oliveira Quinzani | |
| | Regulatory Affairs | |
| Representative/Consultant | Kevin A. Thomas, PhD | |
| | Floyd G. Larson | |
| | PaxMed International, LLC | |
| | 12264 El Camino Real, Suite 400 | |
| | San Diego, CA 92130 | |
| | Telephone: | [phone] |
| | Fax: | [phone] |
| | Email: | [e-mail] |
| | | [e-mail] |

## DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | Intramedullary Nail and Screws - NEONAIL |
|----------------------------|-----------------------------------------------|
| Common Name | Rod, fixation, intramedullary and accessories |
| Classification Name | Intramedullary fixation rod |
| Classification Regulations | 21 CFR 888.3020, Class II |
| Product Code | HSB |
| Classification Panel | Orthopedic Products Panel |
| Reviewing Branch | Joint Fixation Branch One |

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## INTENDED USE

Device Name: Intramedullary Nail and Screws - NEONAIL Femur

Intramedullary Nail and Screws for Femur – NEONAIL is indicated for femoral fracture fixation including:

- Open and closed femoral fractures;
- Pseudoarthrosis and correction osteotomy;
- Pathologic fractures, impending pathologic fractures, and tumor resections;
- Ipsilateral femur fractures;
- Fractures distal to the hip joint; and ●
- Nonunions and malunions. ●

Device Name: Intramedullary Nail and Screws - NEONAIL Tibia

Intramedullary Nail and Screws for Tibia – NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions of the tibia. Intramedullary Nail and Screws for Tibia – NEONAIL is indicated for tibial fracture fixation, which may include:

- . Open and closed tibial fractures:
- . Pseudoarthodlosis and correction osteotomy;
- Pathologic fractures, impending pathologic fractures and tumor resections; and ●
- Nonunions and malunions. ●

#### Intramedullary Nail and Screws - NEONAIL Device Name: Humerus

The Intramedullary Nail and Screws for Humerus – NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.

# DEVICE DESCRIPTION

An intramedullary nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. Intramedullary Nail and Screws – NEONAIL consists of metal rods, bone screws, and end caps. All components are made from Ti-6AI-4V alloy. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations.

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## EQUIVALENCE TO MARKETED DEVICE

Intramedullary Nail and Screws - NEONAIL is substantially equivalent in indications and design principles to the following predicate devices:

- Howmedica Osteonics Corp., T2 Femoral Nail, K010801
- Stryker, T2 Femoral Nail Model 1825-XXXXCP, 1828-XXXXCP, K112059 ●
- Stryker Trauma AG, T2 Tibial Nailing System, K131365 ●
- Howmedica Osteonics Corp., T2 Proximal Humeral Nail, K042396 ●
- Howmedica Osteonics Corp., T2 Nailing System, K032523 ●

Intramedullary Nail and Screws – NEONAIL components have similar designs and identical materials as those cleared under K010801, K112059, K131365, K042396, and K032523. Intramedullary Nail and Screws for Femur – NEONAIL is similar in indications, design, and dimensions to those cleared in K010801 and K112059. Intramedullary Nail and Screws for Tibia - NEONAIL is similar in indications, design, and dimensions to those cleared in K131365. Intramedullary Nail and Screws for Humerus – NEONAIL is similar in indications, design, and dimensions to those cleared in K042396 and K032523.

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: engineering analysis, dimensional analysis and mechanical testing. The worst case nail for each indication in the Intramedullary Nail and Screws - NEONAIL product list was subjected to mechanical performance testing according to ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices (static four-point bending, static torsion, and bending fatigue).

The worst case screws available in the Intramedullary Nail and Screws – NEONAIL product list were subjected to mechanical performance testing according to ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices (static four-point bending and bending fatigue) and ASTM F543 Standard Specification and Test Method for Metallic Bone Screws (torsional properties, driving torque, axial pullout strength, and self-tapping performance).

Clinical data were not submitted in this premarket notification.

Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

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### 510(k) Summary K141103

Overall, Intramedullary Nail and Screws – NEONAIL has the following similarities to the predicate devices:

- has the same intended use, ●
- uses the same operating principle,
- incorporates the same basic design,
- incorporates the same materials, and .
- has similar packaging. ●