EMERGE EXTERNAL FIXATION SYSTEM

K140675 · Emerge Medical, Inc. · KTT · Jun 10, 2014 · Orthopedic

Device Facts

• Record ID: K140675
• Device Name: EMERGE EXTERNAL FIXATION SYSTEM
• Applicant: Emerge Medical, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Jun 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Emerge External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. The system can be used for: Stabilization of soft tissues and fractures Polytrauma/multiple orthopedic trauma Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures Arthrodeses and osteotomies with soft tissue problems; failures of total joints Neutralization of fractures stabilized with limited internal fixation Non-unions/septic non-unions Intra-operative reductions/stabilization tool to assist with indirect reduction Unilateral rectilinear bone segment transport or leg lengthening

Device Story

External fixation system for long bone and pelvic fractures; components include combination clamps, rod-to-rod clamps, rods, pins, and Schanz screws. System allows for unilateral, stacked, bilateral, or modular frame configurations to stabilize fractures or soft tissues. Used by orthopedic surgeons in clinical or surgical settings. Provides mechanical stabilization of bone segments; assists in reduction, transport, or lengthening. Benefits include fracture stabilization and support for complex orthopedic trauma or non-union cases.

Clinical Evidence

Bench testing only. Performance testing conducted per ASTM 1451-02 (2001) demonstrated that the system met all acceptance criteria and performed as well as the predicate device.

Technological Characteristics

Components: 316L Stainless Steel (ASTM F138) for bone-contacting parts; Titanium Alloy (Ti-6Al-4V-ELI, ASTM F136) for clamps; carbon fiber for radiolucent rods. Mechanical fixation system; non-sterile. No software or electronic components.

Indications for Use

Indicated for patients requiring external fixation for long bone and pelvic fractures, including polytrauma, soft tissue stabilization, arthrodeses, osteotomies, non-unions, and leg lengthening.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes: Large External Fixation, MR Conditional (K082650)

Submission Summary (Full Text)

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

# 510(k) SUMMARY Emerge Medical External Fixation System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared: Emerge Medical, Inc.

720 S Colorado Blvd., Suite 550-S Denver. CO 80246

Contact Person:

JUN 1 0 2014

Michelle Potvin, Vice President of Quality Assurance Phone: [phone] Facsimile: 800-698-1440 Email: [e-mail]

# Date Prepared:

March 14, 2014

Common or Usual Name: Emerge External Fixation System Device Classification: Class II; 21 CFR 888.3030

#### Classification Name:

Single/multiple component metallic bone fixation appliances and accessories

Product Code: KTT

#### Device Description:

The Emerge External Fixation System consists of combination clamp, rod-to-rod clamp, rods, pins, Schanz screws and associated instruments for site preparation and implant insertion. All components intended to be attached to bone are fabricated from medical grade stainless steel (3) 6L Stainless Steel per ASTM F138). External clamps are fabricated from Titanium Alloy (Ti-6Al-4V-ELI per ASTM F136), and radiolucent external fixation rods are fabricated from carbon fiber. The Emerge External Fixation System is provided non-sterile.

#### Indications For Use:

The Emerge External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

The system can be used for:

Stabilization of soft tissues and fractures

Polytrauma/multiple orthopedic trauma

Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures Arthrodeses and osteotomies with soft tissue problems; failures of total joints

Neutralization of fractures stabilized with limited internal fixation

Non-unions/septic non-unions

Intra-operative reductions/stabilization tool to assist with indirect reduction Unilateral rectilinear bone segment transport or leg lengthening

6-1

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

# 510(k) SUMMARY Emerge Medical External Fixation System

#### Predicate Device:

Synthes: Large External Fixation, MR Conditional (K082650)

## Performance Data:

Performance testing was conducted per ASTM 1451-02 (2001). In all instances, the Emerge External Fixation System met acceptance criteria, functioned as intended and performed as well as the predicate device.

# Technological Characteristics and Substantial Equivalence:

The Emerge External Fixation System is substantially equivalent to the legally marketed predicate, K082650, based on intended use, basic design, materials, sizing and performance. The systems utilize the same principles of operation allowing for unilateral, stacked, bilateral or modular frame configurations.

The systems contain similar components including large combination clamp (rod to pin clamp), rod-to-rod clamp. rods, pins. and Schanz screws: but have slight geometric differences in clamp designs. The large combination clamp and the rod-to rod clamp of the subject device use different geometrical features to lock the rotation of the clamp bodies with respect to each other when compared to the same style predicate clamps. Additionally, the subject and predicate devices have different shaped clamp body styles.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or extensions, positioned to the right. To the left of the figure, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the figure.

Public Health Service

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

June 10, 2014

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

Re: K140675

Trade/Device Name: Emerge External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: March 27, 2014 Received: March 28, 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 reguirements 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 (reporting of medical

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

Page 2 - Ms. Michelle Potvin

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. .

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins

## for

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

Enclosure

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

## Indications for Use Statement

| | 510(k) Number (if known) | K140675 | |
|--|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |

# Device Name: Emerge External Fixation System

## Indications for Use:

The Emerge External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

The system can be used for:

Stabilization of soft tissues and fractures Polytrauma/multiple orthopedic trauma Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures Arthrodeses and osteotomies with soft tissue problems; failures of total joints Neutralization of fractures stabilized with limited internal fixation Non-unions/septic non-unions Intra-operative reductions/stabilization tool to assist with indirect reduction Unilateral rectilinear bone segment transport or leg lengthening

Prescription Use × (Part 21 CFR 801 Subpart D)

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)

なる。

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices