(17 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 a prosthesis intended to supplement arthroplasty for conditions like hallux limitus, hallux rigidus, and painful rheumatoid arthritis, aiming to act as a dynamic joint spacer to relieve pain and improve joint function, which are therapeutic goals.
No
The device description states it is a "double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint srthroplasty." This describes a therapeutic or surgical implant, not a device used to provide diagnostic information about a patient's condition.
No
The device description clearly states it is a "double-stemmed silicone prosthesis," which is a physical implant, 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. These tests are performed outside of the body.
- Device Description: The Futura Biomedical Classic Great Toe Implant is a physical prosthesis designed to be surgically implanted inside the body to replace a joint. It does not perform any tests on bodily samples.
The information provided clearly describes a surgically implanted medical device, not a diagnostic test performed in a laboratory setting.
N/A
Intended Use / Indications for Use
Futura Biomedical Classic Great Toe Implant is indicated for:
- Hallux limitus or hallux rigidus .
- . Painful rheumatoid arthritis
- Hallux abducto valgus associated with arthritis ●
- Unstable or painful joint from previous surgery .
Product codes (comma separated list FDA assigned to the subject device)
87 KWH
Device Description
The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint srthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Futura Biomedical Flexible Great Toe Implant-K981194
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 0 4 2002
510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the subs determination is based:
| Prepared: | September 13, 2002 |
|---|---|
| ----------- | -------------------- |
- Futura Biomedical Applicant: 990 Park Center Drive, Suite H Vista, CA 92083
| Telephone: | 760-599-1670 |
|---|---|
| Fax: | 760-599-1675 |
| Contact: | Louise M. Focht |
| Device Name: | Prosthesis, Toe, Constrained, Polymer |
|---|---|
| Device Trade Name: | Classic Great Toe Implant |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number | 888.3720 |
| Product Code: | 87 KWH |
| Original Predicate Device: | Futura Biomedical Flexible Great Toe |
| Implant-K981194 | |
| Registration Number: | 2030833 |
| Owner Operator Number: | 9028319 |
Device Description:
The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint srthroplasty. The implant is designed to act as a dynamic joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.
Indications for Use:
Futura Biomedical Classic Great Toe Implant is indicated for:
- Hallux limitus or hallux rigidus .
- . Painful rheumatoid arthritis
- Hallux abducto valgus associated with arthritis ●
- Unstable or painful joint from previous surgery .
1
Comparison to the Original Predicate Device:
The legally marketed predicate device to which this device is substantially equivalent is the Futura Biomedical Flexible Great Toe Implant
Regulatory Class: II Product Code: 87 KWH
Comparison of original Futura Biomedical Flexible Great Toe Implant to the new configuration the Classic Great Toe Implant.
| Item | Original Futura Product | Proposed product configuration |
|---|---|---|
| Product Name | Flexible Great Toe Implant | Classic Great Toe Implant |
| Use | Single use | Single use |
| Fixation | Stem in intramedullary canal | stem in intramedullary canal |
| Constraint | constrained | constrained |
| Material | Silicone | Silicone |
| Sizes | 4 sizes, 20, 30, 40, 50 | 4 sizes 20, 30, 40, 50 |
| Indications for use | Hallux limitus or hallux rigidus | Hallux limitus or hallux rigidus |
| Painful rheumatoid arthritis | Painful rheumatoid arthritis | |
| Hallux abducto valgus associated | ||
| with arthritis | Hallux abducto valgus associated | |
| with arthritis | ||
| Unstable or painful joint from | ||
| previous surgery | Unstable or painful joint from | |
| previous surgery |
Similarities of the Futura Flexible Great Toe Implant and Classic Great Toe Implant include; Both devices are intended for single use only; Both devices are intended for surgical implantation longer than 30 days; Both devices are placed into the intramedullary canal of the metatarsal and phalangeal bones; Both devices are made of the same industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices have the identical for use.
Summary:
The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an abstract symbol resembling three stylized human figures or birds in flight, stacked vertically.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 4 2002
Mr. Louise M. Focht Futura Biomedical 990 Park Center Drive, Suite H Vista, California 92083
Re: K023086 Trade Name: Classic Great Toe Implant Regulation Number: 21 CFR 888.3720 Regulation Name: Toe joint polymer constrained prosthesis Regulatory Class: II Product Code: KWH Dated: September 13, 2002 Received: September 17, 2002
Dear Mr. Focht:
We have reviewed your Section 510(k) premarket 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) 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. Louise M. Focht
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 and additionally 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Q. Mark N. Millbern
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510 (k) Number (If Known):_ Device Name: Classic Great Toe Implant
Indications for Use:
Futura Biomedical Classic Great Toe Implant is indicated for:
- Hallux limitus or hallux rigidus .
- Painful rheumatoid arthritis ●
- Hallux abducto valgus associated with arthritis ●
- Unstable or painful joint from previous surgery ●
Prescription Use
Yes/No
Or
Over the counter use
Yes/No
Mark A. Milken
(Division Sign-Of Division of General in storative and Neurological L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- Number K023086