MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT

K063033 · Orthopedic Sciences, Inc. · HRS · Nov 1, 2006 · Orthopedic

Device Facts

• Record ID: K063033
• Device Name: MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT
• Applicant: Orthopedic Sciences, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Nov 1, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Titanium-TSYTM Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.

Device Story

Titanium-TSY Shoulder Plate Implant is a bone fixation device used to stabilize bone grafts in humeral head and neck intraosseous fractures. It serves as a modification to the previously cleared TSY Shoulder Plate Bone Graft Stabilization System. The device is intended for surgical use by orthopedic surgeons to facilitate bone healing. It functions as a mechanical fixation implant.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation plate; titanium construction; mechanical fixation principle; Class II device (21 CFR 888.3030).

Indications for Use

Indicated for patients requiring stabilization of bone grafts within the humeral head and neck to assist healing of intraosseous fractures.

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

• TSYTM Shoulder Plate Implant (K040850)

Submission Summary (Full Text)

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K063033 Page 1/1

Titanium-TSYTM Shoulder Plate Implant

1 2006 NOV

# 510(k) SUMMARY

### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Orthopedic Sciences, Inc.<br>3020 Old Ranch Parkway,<br>Suite 325<br>Seal Beach, CA 90740 |
|--------------------|-------------------------------------------------------------------------------------------|
| Official Contact: | James K. Brannon. M.D. President/CEO<br>Telephone [phone] FAX [phone] |

DEVICE NAME

| Classification Name: | Plate, fixation, bone |
|-------------------------|---------------------------------------|
| Trade/Proprietary Name: | Titanium-TSYTM Shoulder Plate Implant |
| Common Name: | Bone plate |

### PREDICATE DEVICE INFORMATION

The predicate device for this modification is the TSYTM Shoulder Plate Implant, a component of the TSYTM Shoulder Plate Bone Graft Stabilization System, cleared by FDA on June 24, 2004 under K040850.

### INTENDED USE

The Titanium-TSYTM Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.

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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 a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." arranged around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 1 2006 NOV

Orthopedic Sciences, Inc. % James K. Brannon. M.D. President/CEO 3020 Old Ranch Parkway, Suite 325 Seal Beach. California 90740

Re: K063033

Trade/Device Name: Titanium-TSY" Shoulder Plate Implant Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HRS Dated: September 25, 2006 Received: October 3, 2006

Dear Dr. Brannon:

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 - James K. Brannon, M.D.

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/industry/support/index.html.

Sincerely yours,

Mark N. Mallery

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 (if known):

K063033

Device Name: Titanium-TSY" Shoulder Plate Implant:

Indications For Use:

The Titanium-TSY™ Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.

Prescription Use × (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)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

**510(k) Number** L063033

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