(76 days)
Not Found
Not Found
No
The summary describes a physical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implant for the metatarso-phalangeal joint, intended to treat conditions like arthritic degeneration, pain, and limited motion, thereby restoring normal function. These are therapeutic purposes.
No
The device is described as a resurfacing implant for a joint, designed to correct deformities and treat arthritis and fractures. Its purpose is therapeutic or corrective, not to identify or diagnose conditions.
No
The device description clearly states it is a physical implant made of cobalt chromium with a CPTi coating, designed for surgical insertion. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The SBi Trihedron MTP Hemi Great Toe is described as a resurfacing implant for a joint. It is a physical device designed to be surgically implanted into the body to replace or resurface a damaged joint.
- Intended Use: The intended uses listed are all related to treating conditions affecting the metatarso-phalangeal joint through surgical intervention and implantation of the device.
There is no mention of this device being used to test samples from the body or to provide diagnostic information based on such testing. It is a therapeutic device used in surgery.
N/A
Intended Use / 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 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.
Product codes
KWD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
metatarso-phalangeal joint, proximal phalanx of the great toe
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
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.(b)
Classification. Class II.
0
X062040
510(k) Summary
..............................................................................................................................................................................
OCT - 3 2006
| Manufacturer: | rms Company
8600 Evergreen Boulevard
Minneapolis, MN 55433
763-786-1520 - Office
763-783-5073 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations
James O' Connor
505 Park Avenue, 14th Floor
New York, NY 10022
joconnor@totalsmallbone.com
215-428-1791 - Office
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
Trihedron MTP Hemi Great Toe to be substantially
equivalent to other legally marketed devices. |
| 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. |
| 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 |
1
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
2
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.
3
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:
-
- Arthritic degeneration of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of normal ambulatory function of the forefoot.
-
- Degenerative arthritis
-
- Rheumatoid arthritis
-
- 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