(270 days)
- Repair of long bone fractures due to trauma or reconstruction; a.
- reattachment of the greater trochanter in total hip arthroplasty, surface replacement b. arthroplasty, or other procedures involving trochanteric osteotomy;
- c. sternotomy closure; and
- d. sublaminar and intrafacet wiring of the spinal column.
Not Found
I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the Kinamed Iso-Elastic Cerclage System, stating that the device is substantially equivalent to legally marketed predicate devices.
This type of document primarily confirms that the device can be marketed. It does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes for test sets, data provenance, or study types (retrospective/prospective).
- Information on the number or qualifications of experts for ground truth establishment, or adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes for AI assistance.
- Confirmation of standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- The sample size for the training set or how its ground truth was established.
These details would typically be found in the 510(k) submission itself or in a separate clinical study report, which is not part of this FDA clearance letter.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, composed of three curved lines, symbolizing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2003
Vineet Sarin, Ph.D. Director of Research and Development Kinamed, Inc. 820 Flynn Road Camarillo, California 93012-8701
Re: K030256
Trade/Device Name: Iso-Elastic Cerclage System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Codes: JDQ Dated: July 23, 2003 Received: July 24, 2003
Dear Dr. Sarin:
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 - Vineet Sarin, Ph.D.
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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Wilkerson
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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Kinamed Iso-Elastic Cerclage System, K03-0256 510(k) Response to FDA Memorandum Dated April 9, 2003
Statement of Indication for Use
510(k) Number (if known):
Device Name: Iso-Elastic Cerclage System
Indications for Use:
- Repair of long bone fractures due to trauma or reconstruction; a.
- reattachment of the greater trochanter in total hip arthroplasty, surface replacement b. arthroplasty, or other procedures involving trochanteric osteotomy;
- c. sternotomy closure; and
- d. sublaminar and intrafacet wiring of the spinal column.
Mark N. Mulkern
vision Sien-Off) Division of General, R torative and Neurological Devisis
510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
KO30256
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.