JMEA CANNULATED BONE SCREW SYSTEM

K080259 · Jmea Corporation · HWC · Aug 20, 2008 · Orthopedic

Device Facts

• Record ID: K080259
• Device Name: JMEA CANNULATED BONE SCREW SYSTEM
• Applicant: Jmea Corporation
• Product Code: HWC · Orthopedic
• Decision Date: Aug 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The JMEA cannulated bone screws are used to provide interference fixation of soft tissue grafts in anterior and posterior cruciate ligament repair through arthroscopy or arthrotomy.

Device Story

JMEA Cannulated Bone Screw System consists of titanium alloy screws; cylindrical shape with tapered tip; smooth single or double helix thread design. Used for interference fixation of soft tissue grafts in anterior and posterior cruciate ligament repair. Implanted by surgeons during arthroscopy or arthrotomy procedures. Screw dimensions vary to accommodate graft morphology and patient anatomy. Provides mechanical fixation to stabilize grafts during ligament reconstruction.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material comparison to legally marketed predicate devices.

Technological Characteristics

Titanium alloy construction; cylindrical form factor with tapered tip; smooth single or double helix thread design; cannulated for guide wire placement; sterile; mechanical fixation device.

Indications for Use

Indicated for patients requiring interference fixation of soft tissue grafts during anterior or posterior cruciate ligament repair via arthroscopy or arthrotomy.

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

• Arthrex Cannulated Interference Screw
• Cannulated Interference Screw System (Linvatec)
• Titanium Cannulated Interference Screw (Future Medical Systems)
• Acufex Sterile Cannulated Interference Screws (Acufex Microsurgical)

Submission Summary (Full Text)

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K080259 page 14!

## 510(k) Summary of Safety and Effectiveness for the JMEA Cannulated Bone Screw System

(This tafety and effectiveness summery is provided as required per Section 5130(3) of the Road, Drug and Cornette Act)

510(k) # K080259

8, Material:

## AUG 2 0 2008

| 1. Submitter: | Company: | JMEA Corporation | |
|--------------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Address: | 1 Research Court, Suite 450 | |
| | | Rockville, MD 20850 | |
| | Phone: | 410-746-9583 | |
| | Fax: | 240-752-6073 | |
| 2. Contact name: | Sam Son, M.S.<br>Chief of Regulatory Compliance & Technology | | |
| 3. Date of Submission: | | July 30, 2008 | |
| 4. Name of the device: | | JMEA Cannulated Bone Screw System | |
| 5. Common or usual name: | | Interference screw | |
| 6. Classification: | | 21CFR§888.3040 - Smooth or Threaded Metallic Bone Fixation Fastener<br>21CFR§888.3030 - Single/Multiple Component Metallic Bone Fixation<br>Appliances and Accessories | |

## 7. Predicate or legally marketed Substantially Equivalent Devices:

| Arthrex Cannulated Interference Screw | (Smith & Nephew Dyonics) |
|-----------------------------------------------|--------------------------|
| Cannulated Interference Screw System | (Linvatec) |
| Titanium Cannulated Interference Screw | (Future Medical Systems) |
| Acufex Sterile Cannulated Interference Screws | (Acufex Microsurgical) |

9. Device intended use, description and substantial equivalence:

The titanium alloy screw is cylindrical with a tapered tip and has smooth single or double belix thread design. The JMEA cannulated bone screws are and to provide interference fixation of soft tissue grafts in anterior and posterior cruciate ligament repair through arthroscopy or arthrotomy.

The screw comes in various lengths and diamsters, resulting in a screw design adapted to the graft norphology and patication anatomy.

The titanium alley cannilated interformer screws and the predicate devices have the same overall design, intended use, application and material

There are no significant difference between the JMBA Cannulated Bone Screw System and other cruciate ligament fixation systems currently being marketed, which would adversely affect the safe use of the product.

Based on the comparison of the technological characteristics of the device to the predicate and legally marketed devices, the device is substantially equivalent to other devices on the orthopedic market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a stylized depiction of an eagle and the department's name encircling the eagle. The eagle is represented by three curved lines that form its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

AUG 20 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JMEA Corporation % Mr. Sam Son, M.S. Chief of Regulatory Compliance and Technology 1 Research Court, Suite 450 Rock ville, Maryland 20850

Re: K080259

> Trade/Device Name: JMEA Cannulated Bone Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: August 20, 2008 Received: August 20, 2008

Dear Mr. Son:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 – Mr. Sam Son, M.S.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M Milliman

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

Enclosure

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## Indications for Use

510(k) Number: K080259 Device Name: JMEA Cannulated Bone Screw System

Indications for Use:

The JMEA cannulated bone screws are used to provide interference fixation of soft tissue grafts in anterior and posterior cruciate ligament repair through arthroscopy or arthrotomy.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

Hartian MichMD

Restorative, and Neuro

**510(k) Number**