(44 days)
Not Found
No
The 510(k) summary describes a mechanical implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is designed to treat conditions like hallux limitus, hallux rigidius, painful hallux valgus, revision of failed previous surgery, and painful arthritis by supplementing joint arthroplasty, maintaining range of motion, and reducing pain. These are clear therapeutic functions.
No
Explanation: The device description indicates that it is a "single stemmed resurfacing prosthesis" used to supplement joint arthroplasty, and its purpose is to "reduce impingement... maintain range of motion and reduce pain." These are therapeutic functions, not diagnostic ones. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description clearly describes a physical implant (a single stemmed resurfacing prosthesis) and its material properties and design, indicating it 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The 3S Hemi Toe Implant is a surgical implant designed to be placed inside the body to replace or supplement a joint. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use is to supplement joint arthroplasty and treat conditions like hallux limitus or rigidius. This is a therapeutic intervention, not a diagnostic test.
The information provided clearly describes a surgically implanted device, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The 3S Hemi Toe Implant is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis. This device is for uncemented use.
Product codes (comma separated list FDA assigned to the subject device)
KWD
Device Description
The 3$ Hemi Toe is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adjacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, maintain range of motion and reduce pain without altering the joint biomechanics. The 3S Hemi Toe requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).
Mentions image processing
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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.)
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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.
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.
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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).
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§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.
0
510(k) Summary for the 3S Hemi Toe Implant
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the 3S Hemi Toe Implant.
Date Prepared: October 11, 2007
1. Submitter:
Trilliant Surgical LTD 1630 W. 13th Street03 Houston, TX 77008
Contact Person:
NOY 2 8 2007
J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
- 3$ Hemi Toe Implant 2. Trade name: Hemi toe Common Name: prosthesis, toe, hemi-, phalangeal Classification Name: Class II per 21 CFR section 888.3730 KWD
- Predicate or legally marketed devices which are substantially equivalent: 3. Futura Biomedical Metal Hemi Toe Implant (K971047), Kinetikos Medical K2 Hemi Toe Implant System (K023770), and Townley Great Toe Joint (K911378).
4. Description of the device:
The 3$ Hemi Toe is a single stemmed resurfacing prosthesis for the first proximal phalanx designed to supplement first metatarsal phalangeal joint arthroplasty. The concave congruent articular surface has a mirror finish to minimize friction and matches the adjacent metatarsal head. The oval shape helps to reduce impingement on the metatarsal head, maintain range of motion and reduce pain without altering the joint biomechanics. The 3S Hemi Toe requires minimal bone resection and provides full range of motion of the first metatarsophalangeal joint (MPJ).
Materials:
The substrate of the 3S Hemi Toe is fabricated from CoCrMo alloy per ASTM F799 or F75.
5. Intended Use:
The 3S Hemi Toe Implant is designed to supplement first metatarsal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis. This device is for uncemented use.
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:
The 3S Hemi Toe does not incorporate any new technological characteristics as compared to the predicate device. The 3S Hemi Toe and the predicate devices are made from the same material.
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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 stylized eagle with three lines forming its body and wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2007
Trilliant Surgical Ltd. % Mr. J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd. Round Rock, Texas 78681
Re: K072922
Trade/Device Name: 3S Hemi Toe Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: K.WD Dated: October 11, 2007 Received: October 15, 2007
Dear Mr. Webb:
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
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Page 2 - Mr. J. D. Webb
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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millikan
Mark N. Melkerson 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): __K072922
Device Name: __3S Hemi Toe Implant
Indications for Use:
The 3S Hemi Toe Implant is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis. This device is for uncemented use.
Prescription Use _ X_ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millerson
vision Sign-Off) Division of General, Restorative, and Neurological Devi
510(k) Number