SBI DISTAL RADIUS VOLAR PLATING SYSTEM

K070793 · Small Bone Innovations, Inc. · HRS · May 30, 2007 · Orthopedic

Device Facts

• Record ID: K070793
• Device Name: SBI DISTAL RADIUS VOLAR PLATING SYSTEM
• Applicant: Small Bone Innovations, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: May 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SBi Distal Radius (DR) Volar Plating System is intended for use in fixation of distal radial fractures. The implants are intended for one time use only

Device Story

SBi Distal Radius Volar Plating System provides internal fixation for distal radial fractures. System comprises metallic plates and screws; plates available in various sizes and right/left hand configurations; screws include cortical and cancellous types, some featuring locking capability at varying angles. Device used by orthopedic surgeons in clinical/surgical settings to stabilize fractures. Implants provide mechanical support to bone fragments during healing process; intended for single use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Plates: Grade 1 titanium (ASTM F67). Screws: Ti-6Al-7Nb (ASTM F1295-05) or Ti-6Al-4V (ASTM F136). System includes plates and screws for internal bone fixation. Non-sterile supply.

Indications for Use

Indicated for the fixation of distal radial fractures in patients requiring internal bone fixation.

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)

{0}------------------------------------------------

:

## 510(k) Summary

| Manufacturer: | MAY 30 2007<br>Small Bone Innovations<br>1380 South Pennsylvania Avenue<br>Morrisville, PA 19067<br>215-428-1791<br>215-428-1795 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations<br>1380 South Pennsylvania Avenue<br>Morrisville, PA 19067 |
| Proprietary Name: | SBi Distal Radius Volar Plating System |
| Classification name: | Class II, 888.3030 - Single/multiple component metallic<br>bone fixation appliances and accessories |
| Product Code: | HRS - Plate, Fixation, Bone |
| Common/Usual Name: | Single/multiple component metallic bone fixation<br>appliances and accessories |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBi<br>Distal Radius Volar Plating System to be substantially<br>equivalent to other legally marketed devices. |
| Device Description: | The SBi Distal Radius (DR) Plating System consists of<br>plates and screws that provide internal fixation of the<br>distal radius. The devices are supplied non-sterile and are<br>available in various sizes and configurations. There are<br>several plate configurations in right and left hand<br>orientations. The System also includes an assortment of<br>cortical and cancellous screws some of which can be<br>locked into the plates at varying angles. |
| Intended Use: | The SBi Distal Radius (DR) Volar Plating System is<br>intended for use in fixation of distal radial fractures.<br>The implants are intended for one time use only |
| | |
| Material: | The plates for the SBi DR Plating System are made from<br>Grade 1 titanium per ASTM F67. The screws for the SBi<br>DR Plating System are available in both Ti-6Al-7Nb per<br>ASTM F1295-05 or Ti-6Al-4V per ASTM F136. |

:

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a modern, abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 3 0 2007

Small Bone Innovations, Inc. % Mr. Robert Hoehn Regulatory Associate Musculoskeletal Clinical Regulatory Advisers, LLC 505 Park Avenue, 14th Floor New York, New York 10022

Re: K070793

> Trade/Device Name: SBi Distal Radius Volar Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: May 23, 2007 Received: May 24, 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. Iisting 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

{2}------------------------------------------------

## Page 2 - Mr. Robert Hoehn

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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

for
Mark N. Melkerson

Der D.ascur
5/29/08

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

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number: K070793

Device Name: SBi Distal Radius Volar Plating System

Indications For Use:

The SBi Distal Radius Volar Plating System is intended for use in fixation of distal radial fractures.

Prescription Use V (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

**(Division Sign-Off)**

Sign-Off Division of General. Restorative, and Neurological Devices

**510(k) Number** L070793