(223 days)
The KAPP Patient Matched Ulnar Head Wrist Implant is intended to be used for:
- Replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
- Replacement of the radial head for degenerative, rheumatoid, or post-traumatic disabilities presenting pain and weakness of the wrist joint and resistance to conservative treatment;
- Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and
- Failed ulnar head resection.
It is intended for patient matched use with bone cement and or press-fit fixation.
The Kapp Patient Matched Ulnar Head Wrist Implant includes various sizes of implants and accessory surgical instruments. The implant allows for replacement of the ulnar head.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Kapp Patient Matched Ulnar Head Wrist Implant) and details its identification, description, and indications for use, but does not include performance data, study designs, or acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.
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Attachment 1 - 510(k) Summary
JUL 28 2004
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92, upon which the substantial equivalence determination is based.
Summary Information:
| Applicant: | Kapp Surgical Instrument Co., Inc4919 Warrensville Center RoadWarrensville Heights, Ohio 44128Tel: (216) 587-4400Fax: (216) 587-0411 |
|---|---|
| Contact : | Albert Santilli, President |
| Prepared: | October 31, 2003 |
Device Identification:
| Proprietary Name: | Kapp Patient Matched Ulnar Head Wrist Implant |
|---|---|
| Common Name: | Ulnar Head Implant |
| Classification Nameand Regulation: | Prosthesis, Wrist joint, Hemi-wrist,21 CFR 888.3810, 87KXE |
Predicate Device(s): Avanta Ulnar Head Implant
Device Description:
The Kapp Patient Matched Ulnar Head Wrist Implant includes various sizes of implants and accessory surgical instruments. The implant allows for replacement of the ulnar head.
Indications for use:
The KAPP Patient Matched Ulnar Head Wrist Implant is intended to be used for:
- . Replacement of the distal radioulnar joint following ulnar head resection arthroplasty:
- . Replacement of the radial head for degenerative, rheumatoid, or post-traumatic disabilities presenting pain and weakness of the wrist joint and resistance to conservative treatment;
- . Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and
- . Failed ulnar head resection.
It is intended for patient matched use with bone cement and or press-fit fixation.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the largest profile at the bottom and the smallest profile at the top.
JUL 28 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Albert N. Santilli, Ph.D. President Kapp Surgical Instrument, Inc. 4919 Warrensville Center Road Warrensville Heights, Ohio 44128
Re: K033930
Trade/Device Name: KAPP Surgical Instrument, Inc. Patient Matched Ulnar Wrist Implant Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: II Product Code: KXE Dated: June 18, 2004 Received: June 21, 2004
Dear Dr. Santilli:
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, ard 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 - Albert N. Santilli, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter will and in yourse Fig. finding of substantial equivalence of your device to a legally promatics hoticate 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 dome 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 A. Milburn
Celia M. Witten, Ph.D., M.D. Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 3 - Statement of Indications for Use
K03-3930 510(k) Number:
Device Name: KAPP Surgical Instrument, Inc. Patient Matched Ulnar Wrist Implant
Intended Use / Indications for Use:
The KAPP Patient Matched Ulnar Head Wrist Implant is intended to be used for:
- Replacement of the distal radioulnar joint following ulnar head resection . arthroplasty:
- Replacement of the radial head for degenerative, rheumatoid, or post-● traumatic disabilities presenting pain and weakness of the wrist joint and resistance to conservative treatment;
- Instability of the ulnar head with x-ray evidence of dorsal subluxation and . erosive changes, and
- Failed ulnar head resection. .
- It is intended for patient matched use with bone cement and or press-fit . fixation.
(PLEASE DO NOT WRITE BELOW THIS LINE/CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (6
ice of Device Evaluation (ODE),
Aluh A Milla
Division Sign-Of Division of General, Restorative, and Neurological Devices
K033930
her
510 (k) Number.
Prescription Use
(per 21 CFR 801.109)
OR
Over the Counter Use Optional Format 1-2-96
§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.