(30 days)
The K2 Hemi Great Toe Implant System is indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions; Hallux valgus, hallux rigidus and an unstable or painful MTP joint.
The KMI Great Toe Implant System consists of 4 (four) sizes of toe implants. The implants will now be plasma coated. It is constructed of materials that have a lona clinical history of proven acceptance and performance. This system is intended for press fit use only and will be promoted as such in the Surgical Protocol 81-0065.
The provided text is a 510(k) premarket notification for a medical device called the "K2 Hemi Great Toe Implant System." This document is focused on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not include information about acceptance criteria or a study proving device performance in the context of AI/ML or software validation.
The document discusses:
- Device Name: K2 Hemi Great Toe Implant System
- Intended Use: Treatment of patients with inflammatory arthritis in the first metatarsal joint with good bone stock and integrity of the first metatarsal head, along with clinical conditions like Hallux valgus, hallux rigidus, and unstable/painful MTP joint.
- System Description: Consists of 4 sizes of toe implants, now plasma coated, made of materials with a long clinical history. Intended for press-fit use.
- Equivalence to Marketed Product: States identical design (except for spike feature elimination), identical operating principle/surgical protocol, and identical packaging/sterilization. The primary difference is the addition of a titanium plasma coating.
- Predicate Devices: Harmos Orthopedic, Inc. Great Toe Implant System (K014164) and Futura Biomedical Hemi Toe implant (K971047).
Since the request asks for information related to acceptance criteria and studies that prove device performance, specifically in the context of AI/ML validation metrics, and the provided text is for a physical orthopedic implant seeking 510(k) clearance based on substantial equivalence, the requested information (points 1-9) cannot be extracted from this document. The document confirms that the device is "substantially equivalent" to predicate devices, but this is a regulatory standard, not a performance metric for AI/ML as implied by the questions.
Therefore, I must state that the provided information does not contain the details necessary to answer the questions about acceptance criteria, study design, sample sizes, expert involvement, or AI/ML performance metrics.
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Special 510(k) Notification
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Kinetikos Medical, Inc. 4115 Sorrento Valley Blvd. San Diego, CA 92121 Telephone (858) 558 2233 FAX (858) 558 0838
John Spampinato
Official Contact
Representative
John Spampinato, Quality Assurance Manager Kinetikos Medical, Inc. 4115 Sorrento Valley Blvd. San Diego, CA 92121 Telephone (858) 558 2233 # 406 FAX (858) 558 0838
DEVICE NAME
| Classification Name: | Toe joint, phalangeal, (hemi toe) polymer prosthesis888.3730 |
|---|---|
| Trade/Proprietary Name: | K2 Hemi Toe Implant System |
| Common Name: | Great Toe Prosthesis |
PREDICATE DEVICE INFORMATION
The principal predicate devices for this modification is the Harmos Orthodpedic, Inc., Great Toe Implant System - originally cleared by FDA on March 12, 2002 under K014164, and the Futura Biomedical Hemi Toe implant cleared by FDA on June 20, 1997 under K971047, referenced in this submission owing to its titanium plasma coating, the removal of the spike features and various dimensional changes on the K2 Great Toe Implant.
PACKAGING/LABELING/PRODUCT INFORMATION
Packaging and labeling of the device will be the same as that of the predicate Great Toe Implant. The device will continue to be indicated for press-fit use only. Samples of a package label, product brochure and the surgical technique manual with draft changes in product illustrations, are shown in Exhibit II.
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Special 510(k) Notification - Modification to the Great Toe Implant System - Page 2
INTENDED USE
The Great Toe Implant System is indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions; Hallux valgus, hallux rigidus and an unstable or painful Metatarsal / phalangeal (MTP) ioint.
SYSTEM DESCRIPTION
The KMI Great Toe Implant System consists of 4 (four) sizes of toe implants. The implants will now be plasma coated. It is constructed of materials that have a lona clinical history of proven acceptance and performance. This system is intended for press fit use only and will be promoted as such in the Surgical Protocol 81-0065. Engineering drawings of the implant is shown in Exhibit III.
EQIVALENCE TO MARKETED PRODUCT
The K2 Great Toe implant has the following similarities to the predicate Great Toe implants which previously received 510/k) concurrence:
- -identical design (with the exception of the elimination of the spike features)
- -identical operating principle / surgical protocol
- -is packaged and sterilized using identical materials and processes
The primary distinct difference is the addition of a titanium plasma coating identical to coatings used in cleared, competitive products. In summary, the extra small K2 Hemi Toe Implant System described in this submission is, in our opinion, substantially equivalent to the predicate device.
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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 a stylized image of an eagle with three horizontal lines above it, representing the agency's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administratio 200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2002
Mr. John Spampinato Ouality Assurance Manager Kinetikos Medical, Inc. 4115 Sorrento Valley Boulevard · San Diego, California 92121
Re: K023770
Trade/Device Name: K2 Hemi Great Toe Implant System Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint, phalangeal (hemi-toe), polymer prosthesis Regulatory Class: Class II Product Code: KWD Dated: November 8, 2002 Received: November 12, 2002
Dear Mr. Spampinato:
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 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,
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Page 2 – Mr. John Spampinato
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 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
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Special 510(k) Notification - Modification to the Great Toe Implant System
Device Name: K2 Hemi Great Toe Implant System
Indications for Use:
The K2 Hemi Great Toe Implant System is indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions; Hallux valgus, hallux rigidus and an unstable or painful MTP joint.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONITNUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use_
Over-the-Counter Use
4
Mark N Milken
(Division Sign-Off)
Division of General Restorative
Division of General, Restorative and Neurological Devices
510(k) Number K023770
§ 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.