EMERGE MEDICAL IM NAIL SYSTEM

K141347 · Emerge Medical · HSB · Oct 2, 2014 · Orthopedic

Device Facts

• Record ID: K141347
• Device Name: EMERGE MEDICAL IM NAIL SYSTEM
• Applicant: Emerge Medical
• Product Code: HSB · Orthopedic
• Decision Date: Oct 2, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Emerge Medical IM Nail System is intended to provide temporary stabilization in long bones including the femur, tibia and humerus of various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), correction osteotomy including malalignment, pathologic fractures, impending pathologic fractures, and tumor resections of specific bones. Specific Femoral indications may include supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures proximal to a total knee arthroplasty, and fractures distal to a hip joint. Specific Humeral indications according to AO classification may include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

Device Story

System consists of rigid, cannulated titanium alloy intramedullary (IM) nails, locking screws, and end caps; used for temporary stabilization of long bone fractures (femur, tibia, humerus). Nails inserted into medullary canal; secured via locking screws through proximal/distal holes. Used in clinical/surgical settings by orthopedic surgeons. Provides mechanical fixation to support bone healing; stabilizes fractures, malunions, and nonunions; facilitates correction osteotomy and tumor resection. Benefits patient by restoring structural integrity to fractured bones.

Clinical Evidence

Bench testing only. Dimensional analysis and mechanical testing performed per ASTM F-1264 and ASTM F-543 standards demonstrated performance equivalent or superior to predicate devices. No clinical data required.

Technological Characteristics

Titanium alloy (ASTM F136). Rigid, cannulated intramedullary nail design with locking screws and end caps. Mechanical fixation principle. Sizes vary by application. No software or electronic components.

Indications for Use

Indicated for patients requiring temporary stabilization of long bone fractures (femur, tibia, humerus), including open/closed fractures, malunions, nonunions, correction osteotomies, pathologic fractures, impending pathologic fractures, and tumor resections. Specific femoral and humeral fracture types included.

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

• Stryker IM Nails (K081152)
• Stryker IM Nails (K003018)
• Stryker IM Nails (K043404)
• Emerge Medical Screws (K122489)
• Emerge Medical Screws (K140119)

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

October 2, 2014

Emerge Medical Ms. Michelle Potvin Vice President of Quality Assurance 720 South Colorado Boulevard, Suite 550-S Denver, Colorado 80246

Re: K141347

Trade/Device Name: Emerge Medical IM Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: August 29, 2014 Received: September 2, 2014

Dear Ms. Potvin:

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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Page 2 – Ms. Michelle Potvin

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 Statement

510(k) Number (if known): K141347

## Device Name: Emerge Medical IM Nail System

#### Indications for Use:

The Emerge Medical IM Nail System is intended to provide temporary stabilization in long bones including the femur, tibia and humerus of various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), correction osteotomy including malalignment, pathologic fractures, impending pathologic fractures, and tumor resections of specific bones.

Specific Femoral indications may include supracondylar fractures, including those with intra-articular extension, Ipsilateral femur fractures proximal to a total knee arthroplasty, and fractures distal to a hip joint.

Specific Humeral indications according to AO classification may include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification.

| Prescription Use | X | or Over-The-Counter Use |
|------------------------|---|-------------------------|
| (21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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| 510(k) Summary | |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF FIRM: | Emerge Medical<br>720 S. Colorado Blvd.<br>Suite 550-S<br>Denver, CO 80246 |
| DATE PREPARED: | September 18, 2014 |
| 510(K) CONTACT: | Michelle Potvin<br>Vice President of Quality Assurance<br>Tel: [phone] |
| PROPOSED TRADE NAME: | Emerge Medical IM Nail System |
| DEVICE CLASSIFICATION: | Class II; 21 CFR 888.3020 |
| CLASSIFICATION NAME: | Intramedullary fixation rod |
| PRODUCT CODE: | HSB |
| DEVICE DESCRIPTION: | The System consists of titanium alloy intramedullary (IM) nails<br>locking screws and end caps. The rigid, cannulated IM nails are<br>inserted into the medullary canal and available in a variety of styles<br>and lengths with proximal and distal holes for locking screws. |
| INDICATIONS FOR USE: | The Emerge Medical IM Nail System is intended to provide<br>temporary stabilization in long bones including the femur, tibia and<br>humerus of various types of open or closed fractures including<br>malunions, nonunions (pseudoarthrosis), correction osteotomy<br>including malalignment, pathologic fractures, impending pathologic<br>fractures, and tumor resections of specific bones.<br><br>Specific Femoral indications may include supracondylar fractures<br>including those with intra-articular extension, Ipsilateral femur<br>fractures, fractures proximal to a total knee arthroplasty, and<br>fractures distal to a hip joint. |
| MATERIALS: | Specific Humeral indications according to AO classification may<br>include Type A-Fractures, dislocated, Type B Fractures, dislocated,<br>Type C-Fractures, with intact calotte, or Humeral Fractures<br>according to Neer-Classification.<br>Titanium alloy (ASTM F136) |
| PREDICATE DEVICES: | Stryker IM Nails (K081152, K003018, K043404);<br>Emerge Medical Screws (K122489, K140119) |
| TECHNOLOGIC CHARACTERISTICS: | The fundamental scientific principles and technological<br>characteristics, including the intended use, material, general<br>design, and sizes of the devices are equivalent to the predicate<br>devices. |
| PERFORMANCE DATA: | Dimensional analysis and mechanical testing (ASTM F-1264 and<br>ASTM F-543) demonstrated that the device performs as well as or<br>better than the predicate device. Clinical data were not needed to<br>demonstrate substantial equivalence. |

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