(55 days)
Not Found
No
The device description focuses on the mechanical design and materials of a prosthetic joint, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is intended to resurface the joint in cases of various forms of arthritis or bone loss, and to address painful, unstable thumb or thumb with limited range of motion, which are conditions that therapeutic devices aim to treat or alleviate.
No.
The device description indicates that the Biopro Modular Thumb prosthesis is an implant designed to replace the thumb carpo-metacarpal joint, and its intended use is to resurface the joint in cases of arthritis or bone loss. These are therapeutic and restorative functions, not diagnostic ones.
No
The device description clearly describes a physical, modular thumb prosthesis made of materials like titanium, intended for surgical implantation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant intended to replace a joint in the thumb. It is a physical device implanted into the body.
- Intended Use: The intended use is to "resurface the joint" and address issues like pain, instability, and limited range of motion. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
Therefore, based on the description and intended use, the Biopro Modular Thumb prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Biopro devices are intended to resurface the joint in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which presents themselves as either a painful, instable thumb or a thumb with limited range of motion.
Indications For Use:
- Rheumatoid arthritis
- Traumatic arthritis
- Osteoarthritis
- Post Fracture deformation or bone loss
Product codes
KYI
Device Description
The Biopro Modular Thumb prosthesis has been designed for dysfunction associated with advanced degenerative or rheumatoid arthritis of the thumb carpo-metacarpal joint. The implant is modular and is made available in 3 combinations a neutral a +2mm and +4mm length of 4 head dimensions (12mm-15mm in one millimeter increments) and 4 stem sizes (7.5mm, 8.5mm, 10.0mm and 11.0mm). The tri-flanged and partially porecoated stem provides an immobile press-fitted fixation within the medullary canal. The varus angle of the implant assures the implant remains in contact with the trapezium throughout range of motion, reducing the risk for dislocation. The stem is anatomically configured in the sagital plane to fit the curvature of the metacarpal canal. The head is slightly medialized and is at a 15-20 degree varus angle. The head articulates against the trapezium after a spherical concavity is burred into the trapezium to match the radius of the head.
The implant is sold in a sterile condition. The sterilization method used is Ethylene Oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thumb carpo-metacarpal joint
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3770 Wrist joint carpal trapezium polymer prosthesis.
(a)
Identification. A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.(b)
Classification. Class II.
0
K Q52596
NOV 1 5 2005
510(k) Summary
Submitted By: BioPro 17 17th Street Port Huron, MI 48060
- Contact: Dave Mrak (810) 982-7777 (ext.101) Fax (810) 982-7794
Device Information:
Proprietary Name: BioPro Modular Thumb Implant
Common Name: Prosthesis, Thumb, Hemi, Metacarpal
Classification Name:
Biopro Modular Thumb Implant
The Biopro Modular Thumb prosthesis has been designed for dysfunction associated with advanced degenerative or rheumatoid arthritis of the thumb carpo-metacarpal joint. The implant is modular and is made available in 3 combinations a neutral a +2mm and +4mm length of 4 head dimensions (12mm-15mm in one millimeter increments) and 4 stem sizes (7.5mm, 8.5mm, 10.0mm and 11.0mm). The tri-flanged and partially porecoated stem provides an immobile press-fitted fixation within the medullary canal. The varus angle of the implant assures the implant remains in contact with the trapezium throughout range of motion, reducing the risk for dislocation. The stem is anatomically configured in the sagital plane to fit the curvature of the metacarpal canal. The head is slightly medialized and is at a 15-20 degree varus angle. The head articulates against the trapezium after a spherical concavity is burred into the trapezium to match the radius of the head.
The Biopro devices are intended to resurface the joint in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which presents themselves as either a painful, instable thumb or a thumb with limited range of motion. These indications are the same as those for the predicated device, the Swanson Titanium Condylar Implant. The components function the same, they both resurface the joint to provide pain relief and increase motion in the joint. However, the Biopro implant has interchangeable heads. This allows for flexibility during surgery. Combinations of the heads and stems can be created to match the patients anatomy. There are 48 possible combinations of head and stem assemblies. The modularity allows for better matching to the metacarpal and trapezium for size, it also allows the surgeon to properly tension the joint due to the multiple head lengths, reducing the risk of dislocation and requiring less remodeling of the patients anatomy.
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The implant is sold in a sterile condition. The sterilization method used is Ethylene Oxide.
Substantial Equivalence:
The Biopro Modular Thumb implant is claimed to be substantially equivalent to the Swanson Titanium Condylar Implant (K864488). Both devices resurface the proximal end of the first metacarpal. They have intramedullary stems with a head that acts as a joint spacer. The heads articulate against the distal end of the trapezium which is remodeled to contain the shape of the implant head. The Biopro device is a two piece design and the Swanson is a one piece design. The Biopro device is made of cobalt chrome while the Swanson device is made from unalloyed titanium.
The differences between the subject device and the predicate device follow: First the head diameters are larger for the BIOPRO device than the Swanson components. This provides a wider range of motion for the joint. With the Biopro device, the remodeling of the trapezium is continued into the second metacarpal to prevent impingement of the implant against the bone. Also the cross-section of the stems are different. Both are intended to prevent rotation of the device. however, the Swanson stem is square while the Biopro stem is tri-flanged. The Biopro stem is also anatomically shaped to fit the curvature of the medullary canal in the sagital plane
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 5 2005
David Mrak Director of Product Development BioPro, Inc. 17 17th Street Port Huron, Michigan 48060
Re: K052596
Trade/Device Name: BioPro Modular Thumb Implant Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: II Product Code: KYI Dated: August 2, 2005 Received: September 21, 2005
Dear Mr. Mrak:
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 – David Mrak
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 (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/cdrl/industry/support/index.html.
Sincerely yours,
. Mark N. Melkerson
Mark N. Melkerson Acting Director 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 (if known): K052596
Device Name: Biopro Modular Thumb
Indications For Use:
-
- Rheumatoid arthritis
-
- Traumatic arthritis
-
- Osteoarthritis
-
- Post Fracture deformation or bone loss
Prescription Use xxxxx (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number X052596