SBI TRIHEDRON MTP HEMI GT

K062040 · Small Bone Innovations, Inc. · KWD · Oct 3, 2006 · Orthopedic

Device Facts

• Record ID: K062040
• Device Name: SBI TRIHEDRON MTP HEMI GT
• Applicant: Small Bone Innovations, Inc.
• Product Code: KWD · Orthopedic
• Decision Date: Oct 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SBi Trihedron MTP Hemi Great Toe is intended as a resurfacing implant for the metatarso-phalangeal joint for: 1) Arthritic degeneration of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of normal ambulatory function of the forefoot; 2)Degenerative arthritis; 3)Rheumatoid arthritis; 4)Bunion deformity associated with arthritis of the metatarso-phalangeal joint rheumatoid arthritis; 5) correction of functional deformity; 6) revision procedures where other treatments and devices have failed; and 7) treatment of fractures that are unmanageable using other techniques.

Device Story

SBi Trihedron MTP Hemi Great Toe is a single-piece cobalt chromium implant; consists of head and stem. Stem features CPTi coating for bone integration. Implant inserted into proximal phalanx shaft of great toe; head articulates with distal head of first metatarsal. Available in multiple sizes for left or right feet; includes trial sizers for bone preparation. Used by orthopedic surgeons in clinical settings to resurface MTP joint. Benefits patients by reducing pain, restoring motion, and improving ambulatory function in cases of arthritis, deformity, or fracture.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: ASTM F-1537 wrought cobalt chromium molybdenum alloy; ASTM F-1580 titanium powder coating. Design: Single-piece hemi-arthroplasty implant with stem and articulating head. Dimensions: Multiple sizes available. Sterilization: Not specified.

Indications for Use

Indicated for patients with arthritic degeneration of the metatarsophalangeal (MTP) joint, including degenerative arthritis, rheumatoid arthritis, bunion deformity with arthritis, functional deformity, failed prior treatments, or unmanageable fractures, resulting in disabling pain, limited motion, and loss of ambulatory function.

Regulatory Classification

Identification

A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.

Submission Summary (Full Text)

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X062040

## 510(k) Summary

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OCT - 3 2006

| Manufacturer: | rms Company<br>8600 Evergreen Boulevard<br>Minneapolis, MN 55433<br>763-786-1520 - Office<br>763-783-5073 |
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| 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 Trihedron MTP Hemi Great Toe |
| Classification name: | Class II, 888.3730 - Prosthesis, Toe, Hemi-, Phalangeal |
| Common/Usual Name: | Toe joint phalangeal (hemi-toe) polymer prosthesis |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBi<br>Trihedron MTP Hemi Great Toe to be substantially<br>equivalent to other legally marketed devices. |
| Device Description: | The SBi Trihedron MTP Hemi Great Toe<br>Implant consists of a single piece cobalt chromium head<br>and stem. The stem of the implant is coated with CPTi<br>coating and is designed to be inserted into the shaft of the<br>proximal phalanx of the great toe in the<br>metatarsophalangeal joint. The head of the implant<br>articulates with distal head of the first metatarsal. The<br>implant is available in several sizes, each of which can be<br>used in right or left feet. A range of trial sizers for each<br>size of implant is available to aid in bone preparation. |
| Intended Use: | The SBi Trihedron MTP Hemi Great Toe<br>is intended as a resurfacing implant for the metatarso-<br>phalangeal joint for: 1) Arthritic degeneration of the<br>metatarso-phalangeal joint that has resulted in disabling<br>pain, limited motion and loss of normal ambulatory<br>function of the forefoot; 2)Degenerative arthritis;<br>3)Rheumatoid arthritis; 4)Bunion deformity associated with |

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arthritis of the metatarso-phalangeal joint rheumatoid arthritis; 5) correction of functional deformity; 6) revision procedures where other treatments and devices have failed; and 7) treatment of fractures that are unmanageable using other techniques.

Material:

ASTM F-1537 wrought cobalt chromium molybdenum alloy for surgical implants ASTM F-1580 titanium powders for coating of surgical implants

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 2006

Small Bone Innovations % Mr. James O'Conner 505 Park Avenue, 14th Floor New York, New York 10022

Re: K062040

Trade/Device Name: SBi Trihedron MTP Hemi Great Toe Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: July 13, 2006 Received: July 19, 2006

Dear Mr. O'Conner:

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. James O'Conner

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 10gally 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,

Barbara Buchup

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 Trihedron MTP Hemi Great Toe

Indications for Use:

The SBi Trihedron MTP Hemi Great Toe is intended as a resurfacing implant for the metatarso-phalangeal joint for:

- 1. Arthritic degeneration of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of normal ambulatory function of the forefoot.
- 2. Degenerative arthritis
- 3. Rheumatoid arthritis
- 4. Bunion deformity associated with arthritis of the metatarso-phalangeal joint

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)

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Barbara Bridges for MXP1

Division of General Restorative, and Neurological Devices

**510(k) Number** K062046