SBI RHEAD PLATING SYSTEM

K071549 · Small Bone Innovations, Inc. · HRS · Aug 7, 2007 · Orthopedic

Device Facts

• Record ID: K071549
• Device Name: SBI RHEAD PLATING SYSTEM
• Applicant: Small Bone Innovations, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SBi rHead Plating System is indicated for fractures of the proximal radius.

Device Story

SBi rHead Plating System consists of stainless steel plates and screws designed for fixation of proximal radius fractures. System includes two plate designs: rHead Neck Plate and rHead Rim Plate; both feature curved, T-shaped geometry to match proximal radius anatomy. Plates available in various neck widths, lengths, and hole geometries (threaded/non-threaded). Includes locking and non-locking screws. Used by orthopedic surgeons in clinical settings to stabilize bone fractures, facilitating healing through rigid fixation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Implants manufactured from stainless steel (ASTM F138). System comprises T-shaped plates and locking/non-locking screws. Mechanical fixation device.

Indications for Use

Indicated for patients with fractures of the proximal radius.

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.

Submission Summary (Full Text)

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## 510(k) Summary

| Manufacturer: | Small Bone Innovations International, SA<br>Z.A. Les Bruyeres<br>Peronnas France 01960 | AUG - 7 2007 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitted By: | Small Bone Innovations<br>1380 South Pennsylvania Avenue<br>Morrisville, PA 19067 | |
| Proprietary Name: | SBi rHead Plating System | |
| Classification name: | Class II, 888.3030 - Single / multiple component bone<br>fixation appliances and accessories | |
| Common/Usual Name: | Bone fixation plate | |
| Product Code: | HRS | |
| Substantial Equivalence: | Documentation is provided which demonstrates the SBi<br>rHead Plating System to be substantially equivalent to other<br>legally marketed devices. | |
| Device Description: | The SBi rHead Plating System consists of various plates<br>and screws to treat fractures of the proximal radius. SBi<br>plans to offer two plate designs: the rHead Neck Plate and<br>the rHead Rim Plate. Both have a curved, T-shaped design<br>to match the geometry of the proximal radius. Both will be<br>available in a variety of neck widths, plate lengths, and hole<br>geometries (threaded and non-threaded). Locking and non-<br>locking screws will be included as part of the SBi rHead<br>Plating System. | |
| Intended Use: | The SBi rHead Plating System is indicated for fractures<br>of the proximal radius. | |
| Material: | The implants are made from stainless steel (ASTM F138). | |

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Image /page/1/Picture/13 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol resembles a stylized eagle or bird in flight, composed of curved lines. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Small Bone Innovations Inc. % Mr. Robert Hoehn Senior Regulatory Associate 505 Park Ave. 14th Floor New York, New York 10022

AUG - 7 2007

Re: K071549 Trade/Device Name: SBi rHead Plating System Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II

Product Code: HRS Dated: June 4, 2007 Received: June 6, 2007

Dear Mr. Hoehn:

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. Robert Hoehn

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,

Barbare Byerly

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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## K071549 (pg 1/1)

## Indications for Use

510(k) Number:

Device Name: SBi rHead Plating System

Indications For Use:

The SBi rHead Plating System is indicated for fractures of the proximal radius.

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)

Page 1 of 1

Barbara Buchm

(Div ion-Division of General, Restorative, and Neurological Devices

510(k) Number K071549