(21 days)
Not Found
No
The device description and intended use clearly describe a physical silicone implant for joint replacement, 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 an implant designed to treat conditions like hallux limitus/rigidus and painful rheumatoid arthritis by acting as a joint spacer, thereby alleviating pain and improving joint function.
No
Explanation: The device is an implantable prosthesis designed to act as a joint spacer, not to diagnose a medical 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 prosthesis designed to be implanted into the body to replace a joint. It is a physical device used within the body, not a test performed on a sample.
- Intended Use: The intended use describes treating conditions like hallux limitus, hallux rigidus, and arthritis by supplementing joint arthroplasty. This is a surgical intervention, not a diagnostic test.
The information provided clearly indicates this is a surgically implanted medical device, not an in vitro diagnostic.
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, KWH
Device Description
The Classic Great Toe Implant is a double-stemmed silicone prosthesis, intended to supplement first metatarsophalangeal joint arthroplasty. 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 Classic Great Toe Implant – K023086
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
510 (k) Summary
NOV 1 3 2002
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
| Prepared: | October 21, 2002 |
|---|---|
| Applicant: | Futura Biomedical |
| 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 Classic Great Toe Implant – K023086 |
| 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 arthroplasty. 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:
ca 35cx
page ofa
The legally marketed predicate device to which this device is substantially equivalent is the same device, the Futura Biomedical Classic Great Toe Implant
Regulatory Class: II Product Code: 87 KWH
Comparison of original Futura Biomedical Classic Great Toe Implant to the new configuration the larger size Classic Great Toe Implant.
| Item | Original Futura Product | Proposed product configuration |
|---|---|---|
| Product Name | Classic Great Toe Implant | Classic Great Toe Implant, size 60 |
| Use | Single use | Single use |
| Fixation | Stem in intramedulary canal | Stem in intramedulary canal |
| Constraint | Constrained | Constrained |
| Material | Silicone | Silicone |
| Sizes | 4 sizes, 20, 30, 40, 50 | 5 sizes 20, 30, 40, 50, 60 |
| 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 Classic Great Toe Implant and Classic Great Toe Implant size 60 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Louise M. Focht Futura Biomedical 990 Park Center Drive, Suite H Vista, California 92083
Re: K023562
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: October 21, 2002 Received: October 23, 2002
Dear Ms. 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 (OS) 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 - Ms. 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,
- Mark N Millman
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
4
| 510 (k) Number (If Known): | K023562 |
|---|---|
| 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 .
Marl N Miller
Page
(Division Sign-Off) Division of General, Re- rative and Neurological Devices
510(k) Number_
Prescription Use
Yes/No
or
Over the counter use
Yes/No
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