(89 days)
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 designed to treat conditions like hallux limitus/rigidus, painful rheumatoid arthritis, and hallux abducto valgus associated with arthritis, which are all therapeutic purposes.
No
This device is described as an implantable prosthetic device for joint arthroplasty, acting as a "dynamic joint spacer." Its intended use revolves around treating conditions like hallux limitus/rigidus and painful arthritis. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description clearly states it is a "double-stemmed silicone prosthesis," which is a physical implant, 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.
- Device Description: The description clearly states that this is a "double-stemmed silicone prosthesis to supplement first metatarsophalangeal joint arthroplasty." It is an implant designed to be surgically placed within the body.
- Intended Use: The intended uses are related to treating conditions affecting the first metatarsophalangeal joint through surgical intervention.
There is no mention of analyzing samples from the body or performing diagnostic tests. The device is a physical implant used in surgery.
N/A
Intended Use / Indications for Use
Indications for use of this implant are:
- Hallux limitus or hallux rigidus.
- Painful rheumatoid arthritis.
- Hallux abducto valgus associated with arthritis.
- Unstable or painful joint from previous surgery.
Product codes
KWH
Device Description
The Flexible Great Toe implant is a double-stemmed silicone prosthesis to supplement first metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the head of the 1st metatarsal and base of the proximal phalanx. A grommet option is offered for surgeons who choose to utilize grommets in their surgical procedure. This is consistent with the description and intended use of the Swanson Flexible Hinge Toe Implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
first metatarsophalangeal 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
§ 888.3720 Toe joint polymer constrained prosthesis.
(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.
0
JUN 3 0 1998
Image /page/0/Picture/1 description: The image shows the logo for Futura Biomedical, with the words "FUTURA" and "BIOMEDICAL" stacked on top of each other. To the left of the text is a black square with a white shape inside. To the right of the logo, there is a handwritten "K981".
510(k) Summary
Submitted by:
Jamal D. Rushdy (Point of Contact) Futura Biomedical, L.L.C. 9369 Carroll Park Drive, Suite A San Diego, CA 92121 (619) 643-5149 (619) 452-9945 facsimile
Date of preparation: March 30, 1998
March 30, 199
Trade Name: Futura Biomedical Flexible Great Toe Implant
Common Name:
Flexible Great Toe Implant
Classification Name:
Constrained Polymer Toe Prosthesis per 888.3720 (Class II)
Substantially Equivalent to (predicate device):
Swanson Flexible Hinge Toe Implant by Dow Corning, 510(k) number K780132 (now offered by Wright Medical Technology, Inc., Arlington, TN).
Description/Intended Use:
The Flexible Great Toe implant is a double-stemmed silicone prosthesis to supplement first metatarsophalangeal joint arthroplasty. The implant is designed to act as a dynamic joint spacer between the head of the 1st metatarsal and base of the proximal phalanx. A grommet option is offered for surgeons who choose to utilize grommets in their surgical procedure. This is consistent with the description and intended use of the Swanson Flexible Hinge Toe Implant.
Indications for use of this implant are:
- Hallux limitus or hallux rigidus. .
- Painful rheumatoid arthritis. .
- . Hallux abducto valgus associated with arthritis.
- Unstable or painful joint from previous surgery. .
Technological Characteristics:
The Futura Flexible Great Toe and Predicate device are double-stemmed, silicone implants with a hinged midsection. They both offer titanium press fit grommets.
The angled hinge block of the Flexible Great Toe allows for the normal anatomic insertion of the flexor hallucis brevis tendon to be maintained and removes less of the inferior aspect of the metatarsal head to mitigate sesamoid impingement. The tapered stems and implant face are designed based on the geometry of the resected faces of the proximal phalanx and metatarsal.
There are currently no performance standards for great toe silicone joint implants. The American Society for Testing of Materials (ASTM) has developed voluntary standards for the materials used in the grommets:
F 67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications
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Image /page/1/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 an abstract symbol featuring three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 1998
Mr. Jamal D. Rushdy General Manager Futura Biomedical, L.L.C. 9369 Carroll Park Drive, Suite A San Diego, California 92121
K981194 Re: Flexible Great Toe Implant Trade Name: Regulatory Class: II Product Code: KWH Dated: March 30, 1998 Received: April 2, 1998
Dear Mr. Rushdy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Jamal D. Rushdy
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Whitton, Ph.D., M.D.
ia M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of Indications for Use
K98/194 510(k) Number:
Device Name: Flexible Great Toe
Indications for Use:
and the considerary
- Hallux limitus or hallux rigidus. .
- . Painful rheumatoid arthritis.
- Hallux abducto valgus associated with arthritis. .
- Unstable or painful joint from previous surgery. .
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺎ
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| OR | Over-The-Counter-Use _ |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | 2981194 |