SBI CARPAL FUSION PLATE

K062903 · Small Bone Innovations, Inc. · HRS · Oct 20, 2006 · Orthopedic

Device Facts

• Record ID: K062903
• Device Name: SBI CARPAL FUSION PLATE
• Applicant: Small Bone Innovations, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Oct 20, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SBi Carpal Fusion Plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, lunate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.

Device Story

SBI Carpal Fusion Plate is a low-profile, single-piece metallic construct; designed for dorsal application on carpal bones. Device features spherical holes/slots for screw fixation; fabricated from implantable grade stainless steel. Used by surgeons in clinical settings to stabilize and fuse carpal bones (capitate, hamate, lunate, triquetrum). Provides mechanical fixation to address pain and loss of function resulting from arthritis, fractures, or instability. Benefits patient by facilitating bone fusion and restoring wrist stability.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Low-profile, single-piece plate with spherical holes/slots for screw fixation. Material: Implantable grade stainless steel. Mechanical fixation device.

Indications for Use

Indicated for patients requiring fusion of carpal bones (capitate, hamate, lunate, triquetrum) due to osteoarthritis, post-traumatic arthritis, fractures, failed partial wrist fusion revision, carpal instability, or rheumatoid arthritis.

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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K062903

## 510(k) Summary

| Manufacturer: | rms Company<br>8600 Evergreen Boulevard<br>Minneapolis, MN 55433<br>763-786-1520 - Office<br>763-783-5073 | OCT 20 2006 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitted By: | Small Bone Innovations<br>James O' Connor<br>505 Park Avenue, 14th Floor<br>New York, NY 10022<br>[e-mail]<br>215-428-1791 - Office<br>212-750-2112 - Fax | |
| Proprietary Name: | SBI Carpal Fusion Plate | |
| Classification name: | Class II, 888.3030 - Plate, Fixation, Bone | |
| Common/Usual Name: | Carpal Fusion Plate | |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBI<br>Carpal Fusion Plate to be substantially equivalent to other<br>legally marketed devices. | |
| Device Description: | The SBI Carpal Fusion Plate is a low profile single piece<br>construct designed to fit over the dorsal aspect of the carpal<br>bones in the hand. The plate has spherical holes or slots<br>that accommodate screws for fixation. The plate and<br>screws are fabricated from implantable grade stainless<br>steel. | |
| Intended Use: | The SBi Carpal Fusion Plate is designed for fusion of the<br>carpal bones of the hand including; capitate, hamate,<br>lunate, and triquetrum. The fusion plate is intended for use<br>in patients suffering from pain and/or loss of function due<br>to osteoarthritis, post-traumatic arthritis, fractures, revision<br>of failed partial wrist fusions, carpal instability, or<br>rheumatoid arthritis. The fusion plate is used in<br>conjunction with screws that fix the plate to the carpal<br>bones of the hand. | |
| Material: | The SBI Carpal Fusion plate is made from implantable<br>grade stainless steel. | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Small Bone Innovations Inc. % Mr. Robert Hoehn 505 Park Avenue, 14th Floor New York, New York 10022

OC1 2 0 2006

Re: K062903

Trade/Device Name: SBI Carpal Fusion Plate 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: September 15, 2006 Received: September 27, 2006

Dear Ms. 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 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,
Mark H. Milliken

Mark N. Melkerson 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:

Device Name: SBI Carpal Fusion Plate

Indications For Use:

The SBi Carpal Fusion Plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, and triquetrum. The fusion plate is intendentifor use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate the carpal bones of the hand.

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

Mark N. Mekean

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

510(k) Number K062903