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K Number
K062040
Device Name
SBI TRIHEDRON MTP HEMI GT
Manufacturer
SMALL BONE INNOVATIONS INC.
Date Cleared
2006-10-03

(76 days)

Product Code
KWD
Regulation Number
888.3730
Type
Traditional
Panel
Orthopedic
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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
  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 Description

The SBi Trihedron MTP Hemi Great Toe Implant consists of a single piece cobalt chromium head and stem. The stem of the implant is coated with CPTi coating and is designed to be inserted into the shaft of the proximal phalanx of the great toe in the metatarsophalangeal joint. The head of the implant articulates with distal head of the first metatarsal. The implant is available in several sizes, each of which can be used in right or left feet. A range of trial sizers for each size of implant is available to aid in bone preparation.

AI/ML Overview

There is no information regarding acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) summary for the SBi Trihedron MTP Hemi Great Toe, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on performance against specific acceptance criteria through a clinical study.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone performance, or details about the training set.

The document states: "Documentation is provided which demonstrated the SBi Trihedron MTP Hemi Great Toe to be substantially equivalent to other legally marketed devices." This indicates that the regulatory approval was based on a comparison to existing devices, not on a new study assessing specific performance metrics against pre-defined acceptance criteria.

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X062040

510(k) Summary

..............................................................................................................................................................................

OCT - 3 2006

Manufacturer:rms Company8600 Evergreen BoulevardMinneapolis, MN 55433763-786-1520 - Office763-783-5073
Submitted By:Small Bone InnovationsJames O' Connor505 Park Avenue, 14th FloorNew York, NY 10022joconnor@totalsmallbone.com215-428-1791 - Office212-750-2112 - 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 SBiTrihedron MTP Hemi Great Toe to be substantiallyequivalent to other legally marketed devices.
Device Description:The SBi Trihedron MTP Hemi Great ToeImplant consists of a single piece cobalt chromium headand stem. The stem of the implant is coated with CPTicoating and is designed to be inserted into the shaft of theproximal phalanx of the great toe in themetatarsophalangeal joint. The head of the implantarticulates with distal head of the first metatarsal. Theimplant is available in several sizes, each of which can beused in right or left feet. A range of trial sizers for eachsize of implant is available to aid in bone preparation.
Intended Use:The SBi Trihedron MTP Hemi Great Toeis intended as a resurfacing implant for the metatarso-phalangeal joint for: 1) Arthritic degeneration of themetatarso-phalangeal joint that has resulted in disablingpain, limited motion and loss of normal ambulatoryfunction of the forefoot; 2)Degenerative arthritis;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 (240) 276-0120 . 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 (800) 638-2041 or (301) 443-6597 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.
    1. Degenerative arthritis
    1. Rheumatoid arthritis
    1. 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)

Page 1 of 1

Barbara Bridges for MXP1

Division of General Restorative, and Neurological Devices

510(k) Number K062046

N/A