EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM

K131480 · Emerge Medical · HRS · Jul 3, 2013 · Orthopedic

Device Facts

• Record ID: K131480
• Device Name: EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
• Applicant: Emerge Medical
• Product Code: HRS · Orthopedic
• Decision Date: Jul 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Emerge Locking One-third Tubular Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

Device Story

System consists of stainless steel locking plates, standard cortex screws, locking cortex screws, and standard cancellous screws with washers. Used for internal fixation of bone fractures, osteotomies, and non-unions in various anatomical sites including clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula. Designed for use in osteopenic bone. Components are provided non-sterile. Intended for surgical use by physicians to stabilize bone segments, facilitating healing and structural support.

Clinical Evidence

No clinical data provided. Substantial equivalence demonstrated via bench testing (mechanical performance) according to ASTM F543 and ASTM F382 standards.

Technological Characteristics

Stainless steel (ASTM F138 and F139). System includes locking plates, standard cortex screws, locking cortex screws, and cancellous screws/washers. Mechanical performance validated per ASTM F543 and ASTM F382. Non-sterile delivery.

Indications for Use

Indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including patients with osteopenic bone.

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 (K011335)

Submission Summary (Full Text)

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## 510(k) Summary

| NAME OF FIRM: | Emerge Medical<br>790 S. Colorado Blvd.<br>Suite 550-S<br>Denver, CO 80246 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | May 20, 2013 |
| 510(K) CONTACT: | Victoria Trafka<br>Vice President of Engineering & Quality<br>Tel: [phone]<br>Fax: [phone] |
| PROPOSED TRADE NAME: | Emerge Medical Locking One-third Tubular Plate System |
| DEVICE CLASSIFICATION: | Class II; 21 CFR 888.3030 and 888.3040 |
| CLASSIFICATION NAME: | Plate, Fixation, Bone; Smooth or threaded metallic bone fixation<br>fastener |
| PRODUCT CODE: | HRS and HWC |
| DEVICE DESCRIPTION: | The System consists of stainless steel components including<br>locking plates and standard cortex screws, locking cortex screws<br>and standard cancellous screws and washers. The plates are<br>available in a variety of lengths with the number of holes varying<br>depending on plate length. The screws and plates are provided<br>non-sterile. |
| INDICATIONS FOR USE: | The Emerge Medical Locking One-third Tubular Plate System is<br>intended for fixation of fractures, osteotomies, and non-unions of<br>the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis,<br>distal tibia, and fibula, including osteopenic bone. |
| MATERIALS: | Stainless steel (ASTM F138 and F139) |
| PREDICATE DEVICES: | Synthes K011335 |
| TECHNOLOGIC<br>CHARACTERISTICS: | The fundamental scientific principles and technological<br>characteristics, including the intended use, material, general<br>design, and sizes of the device are equivalent to the predicate<br>device. |
| PERFORMANCE DATA: | Mechanical testing performed according to ASTM F543 and ASTM<br>F382 demonstrated that the device performs as well as or better<br>than the predicate device. Clinical data were not needed to<br>demonstrate substantial equivalence. |

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized lines forming the body and wings, and two curved lines representing the legs or tail.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

#### July 3, 2013

Emerge Medical % Ms. Victoria Trafka Vice President of Engineering and Quality 790 South Colorado Road, Suite 550-S Denver, Colorado 80246

Re: K131480

Trade/Device Name: Emerge Medical Locking One-Third Tubular Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: May 31, 2013 Received: June 13, 2013

#### Dear Ms. Trafka:

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 (reporting of medical

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#### Page 2 - Ms. Victoria Trafka

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Erin Keith

· 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): K131480

Device Name: Emerge Medical Locking One-Third Tubular Plate System

Indications for Use:

The Emerge Locking One-third Tubular Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × 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)

Elizabeth L. Frank -S

Division of Orthopedic Devices