EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM

K102343 · Emerge Medical · HWC · Nov 23, 2010 · Orthopedic

Device Facts

• Record ID: K102343
• Device Name: EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM
• Applicant: Emerge Medical
• Product Code: HWC · Orthopedic
• Decision Date: Nov 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Emerge Medical Cannulated Screw Fixation System is intended to provide bone fixation in the management of fractures of both small and large bones and bone fragments, including those in the foot, patella, ankle, wrist, and elbow and arthrodesis of the foot, wrist, and elbow and small and long bone osteotomies.

Device Story

Cannulated bone screws; various diameters, lengths, and thread configurations; machined from 316L stainless steel or titanium alloy. Central cannulation allows placement over guide wires; screw heads mate with standard orthopedic drivers. Used by orthopedic surgeons in clinical settings for bone fixation, arthrodesis, and osteotomies. Provided sterile or non-sterile. No specialized instruments required; compatible with generic orthopedic instrumentation. Benefits include stabilization of bone fragments to facilitate healing.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via mechanical testing including screw torsional strength, axial pullout, and driving/removal torque, showing equivalence to predicate devices.

Technological Characteristics

Materials: 316L stainless steel or titanium alloy. Design: Cannulated shaft for guide wire placement; various diameters/lengths. Energy source: None (manual). Connectivity: None. Sterilization: Provided sterile or non-sterile. Software: None.

Indications for Use

Indicated for bone fixation in management of fractures of small and large bones/fragments (foot, patella, ankle, wrist, elbow), arthrodesis (foot, wrist, elbow), and small/long bone osteotomies.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes Cannulated Screw System (K962011)
• Synthes Cannulated Screw System (K962823)
• Synthes Cannulated Screw System (K963172)
• Synthes Cannulated Screw System (K963192)
• Synthes Cannulated Screw System (K012945)
• Synthes Cannulated Screw System (K021932)

Submission Summary (Full Text)

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# 510(k) Summary

NOV 2 3 2010

#### Emerge Medical - Cannulated Screw Fixation System (K102343)

Nov. 11.2010

#### Submitter/Regulatory Contact:

Curtis Raymond - Orchid Design 80 Shelton Technology Center - Shelton, CT 06484 Tel: [phone]

### Sponsor/Manufacturer:

Emerge Medical 1530 Blake Street - Suite 204 Denver, CO 80202

FDA Establishment Registration Number: Awaiting Assignment Owner Operator Number: 10033339

Trade Name, Common Name, Classification:

Device Trade Name: Emerge Medical Cannulated Screw Fixation System

Device Common or Usual Names: Bone Fixation Screws

Classification: Class II

Classification Name: screw, fixation, bone

Regulation: 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener)

Product Code: HWC

Predicate Devices: Synthes Cannulated Screw System:

> K962011 (7.0, 7.3mm) K962823 (3.0mm) K963172 (4.5mm) K963192 (3.5, 4.0mm) K012945 (2.4mm) K021932 (6.5mm)

#### Description of the Device:

The Emerge Medical Cannulated Bone Screw set consists of various size bone screws. The screws are available in a variety of sizes differing in diameter, overall length

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and threaded length. The screws are machined from 316 L stainless steel or titanium alloy.

Each screw is cannulated with a hole through the center for use with appropriately sized guide wires. The screw heads have various configurations which mate with commonly used drivers. No specialized instruments are required for placement of the screws.

The screws have mating washers which can be slipped over the shaft of the screw and fit under the screw head. The screws are used with generic instruments commonly available to orthopedic surgeons.

The devices are provided both in non-sterile or in sterile packages as preferred by the user.

#### Intended Use:

The Emerge Medical Cannulated Screw Fixation System is intended to provide bone fixation in the management of fractures of both small and large bones and bone fragments, including those in the foot, patella, ankle, wrist, and elbow and arthrodesis of the foot, wrist, and elbow and small and long bone osteotomies.

#### Technological Characteristics:

The subject device is substantially equivalent to the predicate devices. Both the subject device and predicate devices have a similar designs, materials and indications. The materials comprising the device (316L stainless steel or titanium alloy) are commonly used for orthopedic implants and have a long history of biocompatibility

#### Performance:

The devices have been subjected to recognized consensus standards and perform in a manner equivalent to the predicate devices. Testing included

Screw Torsional Strength,

Screw Axial Pullout,

Screw Driving and Removal Torque

In all instances. Emerge screws were shown to be substantially equivalent to the predicate screws.

#### Conclusion:

We believe that based on the predicate device comparison and the non-clinical testing performed the subject device is substantially equivalent to the predicate devices and conclude that the subject devices are as safe and effective as the predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Emerge Medical % Orchid Design Mr. Curtis Raymond 80 Shelton Technology Center Shelton, CT 06484

NOV 2 3 2010

Re: K102343

Trade/Device Name: Emerge Medical Cannulated Screw Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 12, 2010 Received: November 15, 2010

Dear Mr. Raymond:

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

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Page 2 - Mr. Curtis Raymond

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Barbara Bonehp

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

Enclosure

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## Indications for Use

510(k) Number (if known): Klo23436pg \/וֹ (

NOV 2 3 2010

Emerge Medical Cannulated Screw Fixation System Device Name:

Indications For Use:

The Emerge Medical Cannulated Screw Fixation System is intended to provide bone fixation in the management of fractures of both small and large bones and bone fragments, including those in the foot, patella, ankle, wrist, and elbow and arthrodesis of the foot, wrist, and elbow and small and long bone osteotomies.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K102343