(220 days)
The KMI Katalyst Radial Head Implant is generally indicated for radial head replacement arthroplasty. Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.
The KMI Katalyst Radial Head implant is intended for use in radial head replacement arthroplasty. The system consists of modular stem and head components to accommodate variations in human anatomy. The design incorporates an adjustable stem length capability to allow stem length adjustment in-sito.
Materials: -Cobalt Chrome, per ASTM F75 -Stainless Steel BioDur 108 Alloy per ASTM F2229 -UHMWPE per ASTM 648-00
Function: The system functions as a replacement for the proximal radial head.
The provided text is related to a 510(k) premarket notification for a medical device called the "Katalyst Radial Head Implant." It describes the device, its intended use, and its substantial equivalence to other legally marketed devices.
However, the document does not contain any information about acceptance criteria, study design, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance).
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details. The document is a regulatory submission for premarket clearance based on substantial equivalence, not a report of a clinical performance study.
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APR 1 6 2004
APPENDIX I SUMMARY OF SAFETY AND EFFECTIVENESS
For
Katalyst Radial Head Implant
-
- Submitter:
Kinetikos Medical, Inc. 6005 Hidden Valley Rd. Suite 180 Carlsbad, CA 92009
- Submitter:
Contact Person:
John G. Spampinato V.P., Quality Assurance Kinetikos Medical, Inc. 6005 Hidden Valley Road Suite 180 Carlsbad, CA 92009 (760) 448 1706 FAX (760) 448 1739
Date Prepared: September 08, 2003
| 2. Trade Name: | Katalyst Radial Head Implant |
|---|---|
| Common Name: | Radial Head Implant |
| Classification Name: | Orthopedic Elbow Implant |
Predicate or legally marketed devices which are substantially equivalent 3.
-Avanta R Head Recon Radial Implant System -Tornier BiPolar Radial Head Prosthesis -Biomet Liverpool Radial Head Replacement -Wright Medical Evolve Modular Radial Head
Description of Device র্ব
The KMI Katalyst Radial Head implant is intended for use in radial head replacement arthroplasty. The system consists of modular stem and head components to accommodate variations in human anatomy. The design incorporates an adjustable stem length capability to allow stem length adjustment in-sito.
-UHMWPE per ASTM 648-00 Materials: -Cobalt Chrome, per ASTM F75 -Stainless Steel BioDur 108 Alloy per ASTM F2229
Function: The system functions as a replacement for the proximal radial head.
5. Intended Use
The KMI Katalyst Radial Head Implant is generally indicated for radial head replacement arthroplasty.
Use of the implant is contraindicated in those cases where complete avascular necrosis has rendered bone stock inadequate.
Comparison of technological characteristics of the device to predicate and legally 6. marketed devices:
There are no significant differences between the KMI Katalyst Radial Head Implant and other radial head replacement systems currently being marketed which would adversely affect the use of the product. The KMI Katalyst Radial Head Implant employs the same materials and basic mechanical features as the predicate, legally marketed devices specified in section I in that the essential configuration consists of multiple size heads and stems to facilitate modularity that will accommodate a broad spectrum of patient anatomies.
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Public Health Service
Image /page/1/Picture/2 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 emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2004
Mr. John G. Spampinato Vice President, Quality Assurance Kinetikos Medical, Inc. 6005 Hidden Valley Road, Suite 180 Carlsbad, California 92009
Rc: K032806
Trade/Device Name: Katalyst Radial Head Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: January 30, 2004 Received: February 9, 2004
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 cquivalence 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 G. Spampinato
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter with and h your de finding of substantial equivalence of your device to a legally premaince modicate 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 If you deems specific as 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,
Sincerely yours,
/ Mark 71 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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Indications for Use
510(k) Number (if known):___K032806
Device Name:___Katalyst Radial Head
Indications For Use:
The KMI Katalyst Radial Head system is generally indicated for use in radial head replacement arthroplasty.
Use of the implant is contraindicated in those cases where complete vascular necrosis had rendered bone stock inadequate
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Eval
Mark D. Milhousen
storative. Division of Cre d Neurologic ar
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§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.