(88 days)
No
The device description and intended use focus on a physical implant for joint replacement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to resurface a joint to address conditions such as arthritis, which are considered therapeutic interventions for existing medical conditions.
No
This device is a replacement implant for a joint, used to resurface the joint in cases of various forms of arthritis and bone loss. Its purpose is to physically replace and improve joint function, not to diagnose medical conditions or diseases.
No
The device description clearly describes a physical implant made of cobalt, intended for surgical implantation in the basal thumb joint. This is a hardware medical 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The BIOPRO Cobalt Trapeziometacarpal Replacement is a surgical implant designed to replace a joint in the thumb. It is physically inserted into the body.
- Intended Use: The intended use describes treating conditions like arthritis and post-fracture issues by resurfacing the joint. This is a therapeutic intervention, not a diagnostic test.
The information provided clearly describes a surgically implanted device for treating a physical condition, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The BIOPRO Cobalt Trapeziometacarpal Replacement is intended to resurface the joint in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present themselves as either a painful, instable thumb with limited range of motion.
Product codes
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Device Description
The BIOPRO Cobalt Trapeziometacarpal Replacement is a one-piece resurfacing component for the basal thumb joint. It has an anatomically configured tri-flanged stem that fits into the medullary canal at the proximal end of the first metacarpal. This tri-flanged configuration allows for compaction of bone around the implant to provide stable fixation and to prevent rotation of the device. The head is spherical and extends just beyond a hemisphere, slightly medialized on the stem and is at a 20° varus angle to the stem to properly space the joint and allow for sufficient range of motion. The trapezium is resurfaced to contain the head of the implant and this resurfacing is continued into the second metacarpal. Resurfacing the second metacarpal prevents impingement of the implant against that bone and decreases the possibility of dislocation of the joint.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
basal thumb 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Swanson Titanium Condylar Implant (K864488)
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
,
Submitter: BIOPRO 17 Seventeenth Street Port Huron, MI 48060 (810) 982-7777
FEB -3 1997
Valerie Gardner Contact:
Date: October 25, 1996
Device Name: BIOPRO Cobalt Trapeziometacarpal Replacement
Classification: The FDA has not yet created a classification for this type of device.
Predicate Device: Swanson Titanium Condylar Implant (K864488)
The BIOPRO Cobalt Trapeziometacarpal Replacement is a one-piece resurfacing component for the basal thumb joint. It has an anatomically configured tri-flanged stem that fits into the medullary canal at the proximal end of the first metacarpal. This tri-flanged configuration allows for compaction of bone around the implant to provide stable fixation and to prevent rotation of the device. The head is spherical and extends just beyond a hemisphere, slightly medialized on the stem and is at a 20° varus angle to the stem to properly space the joint and allow for sufficient range of motion. The trapezium is resurfaced to contain the head of the implant and this resurfacing is continued into the second metacarpal. Resurfacing the second metacarpal prevents impingement of the implant against that bone and decreases the possibility of dislocation of the joint.
The BIOPRO Cobalt Trapeziometacarpal Replacement is intended to resurface the joint in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present themselves as either a painful, instable thumb with limited range of motion. These indications are the same as those for the predicate device, the Swanson Titanium Condylar Implant (K864488). The other similarities, and also the differences, between the subject device and the predicate device include their functions, materials and shapes. The components function the same; they both resurface the joint to provide pain relief and increase motion in the joint. Both components have a hemispherical head, however the ratio of head height to head diameter is slightly larger for the Swanson device than for the BIOPRO component. Also, while the head of the Swanson device is cylindrical below the hemisphere, the BIOPRO head continues the spherical radius to the edge of the head to increase the range of motion of the joint. Both devices' stems are intended to prevent rotation; however, their cross-sections are different. The Swanson device has a square cross-section and the BIOPRO device has a tri-flanged cross-section. The only other difference between the devices is the material. The BIOPRO component is manufactured from cast Cobalt Chrome (to ASTM F75) while the Swanson device
1
is manufactured from unalloyed titanium (to ASTM F 67). The use of cobalt as opposed to titanium allows for casting of the device. Also, cobalt chrome is not as soft a material as titanium which better suits the metal for use as an articulating surface
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