MODIFICATION TO SHOULDER FIXATION SYSTEM

K051728 · Hand Innovations, LLC · LXT · Jul 20, 2005 · Orthopedic

Device Facts

• Record ID: K051728
• Device Name: MODIFICATION TO SHOULDER FIXATION SYSTEM
• Applicant: Hand Innovations, LLC
• Product Code: LXT · Orthopedic
• Decision Date: Jul 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

Device Story

Modified Shoulder Fixation System consists of orthopedic plates, multidirectional/90° lock screws, 90° set screws, and pegs; supplied in sterilization tray with reusable/disposable tools. Used by surgeons in clinical settings for internal fixation of proximal humerus fractures, dislocations, osteotomies, and non-unions. Provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data; substantial equivalence confirmed through pre-clinical testing.

Technological Characteristics

Materials: Stainless steel meeting ASTM F 138. Components: Orthopedic plates, multidirectional/90° lock screws, 90° set screws, pegs. System includes reusable and disposable instruments. Sterilization tray provided.

Indications for Use

Indicated for patients with fractures, fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

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

• Shoulder Fixation System (K042059)

Submission Summary (Full Text)

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JUL 2 0 2005

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## 510(k) Summary of Safety and Effectiveness

| General<br>Provisions | The name of the device is: |
|-----------------------|----------------------------|
|-----------------------|----------------------------|

| | <table><tr><th>Proprietary Name</th><th>Common or Usual Name</th></tr><tr><td>Modified Shoulder Fixation System</td><td>Plate Fixation Bone</td></tr></table> | Proprietary Name | Common or Usual Name | Modified Shoulder Fixation System | Plate Fixation Bone |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------------|-----------------------------------|---------------------|
| Proprietary Name | Common or Usual Name | | | | |
| Modified Shoulder Fixation System | Plate Fixation Bone | | | | |
| Name of<br>Predicate<br>Devices | The device is substantially equivalent to:<br>• Shoulder Fixation System (510(k) # K042059 - September 30, 2004) - Hand<br>Innovations, Inc. | | | | |
| Classification | Class II. | | | | |
| Performance<br>Standards | Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act. | | | | |
| Indications for<br>Use | The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus. | | | | |
| Device<br>Description | The Modified Shoulder Fixation System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices:<br>• Shoulder Plates<br>• Multidirectional and 90° Lock Screws<br>• 90° Set Screws<br>• Pegs<br> | | | | |
| | Also, provided in the sterilization tray are the re-useable instruments | | | | |
| Biocompati-<br>bility | The implantable components of the Modified Shoulder Fixation System and instruments do not require biocompatibility testing because the stainless steel used in fabrications meets the requirements of ASTM F 138. | | | | |
| Summary of<br>Substantial<br>Equivalence | The Modified Shoulder Fixation System is substantially equivalent to the predicate Shoulder Fixation System. The equivalence was confirmed through pre-clinical testing. | | | | |

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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 features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2005

Mr. Ernesto Hernandez Vice President RA/QZ Hand Innovations, LLC 8905 SW 87TH Avenue, Suite 220 Miami, Florida 33176

Re: K051728 Trade/Device Name: Shoulder Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LXT Dated: June 24, 2005 Received: June 27, 2005

Dear Mr. Hernandez:

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. Ernesto Hernandez

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Shoulder Fixation System

### Indications for Use Statement

The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

OR

Over-The-Counter Use ______________________________________________________________________________________________________________________________________________________________________________

E. G. F.

vision Sign-Off) ion of General, Restorative

Number K051728