(76 days)
Not Found
No
The device description and intended use clearly describe a mechanical implant system for wrist fusion, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as a system for wrist arthrodesis, providing fixation for bones due to various conditions like arthritis and fractures, all of which aim to treat pain and loss of function. This therapeutic intervention classifies it as a therapeutic device.
No
Explanation: The device is described as a "Wrist Fusion System" composed of metal plates and screws. Its intended use is for wrist arthrodesis, providing fixation for small bones and treating conditions, not for diagnosing them.
No
The device description explicitly states that the system consists of metal plates and screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- KMI Wrist Fusion System Function: The KMI Wrist Fusion System is a surgical implant (metal plates and screws) used to fuse bones in the wrist. It is used within the body during a surgical procedure to provide structural support and stability.
The description clearly indicates a device used for surgical intervention and bone fixation, not for testing biological samples.
N/A
Intended Use / Indications for Use
The KMI Wrist Fusion System is comprised of the total wrist fusion plate which is intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones and indicated for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, or rheumatoid arthritis, and the KMI limited wrist fusion plate is intended for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The KMI Wrist Fusion System consists of metal plates with holes to accommodate specific screws and the screws, all manufactured of 316L stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, radius, carpal bones, hand, foot, ankle, elbow
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 applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
KMI Wrist Fusion System-K990094, Howmedica ICS Mini and Small Fragment Set-K800806
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.
Not Found
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).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
AUG 17 1999
Image /page/0/Picture/1 description: The image shows the logo for Kinetikos Medical Incorporated. The words "KINETIKOS MEDICAL" are stacked on top of the letters "KMI". The word "INCORPORATED" is stacked below the letters "KMI".
Image /page/0/Picture/2 description: The image contains a series of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '99', a forward slash '/', and then the numbers '873'. The handwriting style appears somewhat cursive and the numbers are closely spaced together.
"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."
I. Summary of Safety and Effectiveness for the KMI™ Wrist Fusion System
| 1. Submitter's name, address, telephone and fax number: | Kinetikos Medical Inc.
4115 Sorrento Valley Road
San Diego, CA 92121
Telephone: 619-558-2233
FAX: 619-558-0838 |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael Collins, Director of Engineering |
| Date Summary Prepared: | May 25, 1999 |
| 2. Name of Device: | |
|---|---|
| Proprietary Name: | KMI Wrist Fusion System |
| Common/Usual Name: | Plate, fixation, bone |
| Classification Name: | Plate, fixation, bone |
| 3. Predicate Device: | KMI Wrist Fusion System-K990094, and
Howmedica ICS Mini and Small Fragment Set-K800806 |
| ---------------------- | ------------------------------------------------------------------------------------------- |
|---|
4. Description of Device:
The KMI Wrist Fusion System consists of metal plates with holes to accommodate specific screws and the screws, all manufactured of 316L stainless steel.
- Intended Use: The current KMI Wrist Fusion System (K990094) is intended for 5. wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones and indicated for use in patients suffering pain and/or loss of function due to osteoarthritis, posttraumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, or rheumatoid arthritis, while the KMI limited wrist fusion plate is intended for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The Howmedica ICS Mini and Small Fragment Set (K800806) is used for stabilizing fractures of the small bones of the hand, foot, ankle and elbow until bony union can occur. These intended uses are substantially equivalent and do not affect safety or effectiveness.
-
- Technological Characteristics: The current KMI Wrist Fusion System, the KMI limited wrist fusion plate, and the Howmedica ICS Mini and Small Fragment Set consist of metal plates with holes to accommodate specific screws and the screws, all manufactured of 316L stainless steel. There are no technological characteristics that raise new issues of safety or effectiveness.
1
Image /page/1/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated. The words "KINETIKOS MEDICAL" are printed in a smaller font size above the letters "KMI", which are in a much larger font size. The word "INCORPORATED" is printed in a smaller font size below the letters "KMI".
Summary of Safety and Effectiveness for the KMI™ Wrist Fusion System page 2 of 2
-
- Summary of Performance Date: Not applicable.
-
- Conclusions Drawn from Nonclinical and Clinical Tests: Not applicable.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white and has a simple, official design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 17 1995
Mr. Michael Collins Director of Engineering Kinetikos Medical, Inc. 4115 Sorrento Valley Road San Diego. California 92121
K991873 Re:
Trade Name: KMI Wrist Fusion System Regulatory Class: II Product Code: HRS Dated: June 1, 1999 Received: June 2, 1999
Dear Mr. Collins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
3
Page 2 - Mr. Micheal Collins
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Aurrell J. Payne
An Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated. The words "KINETIKOS MEDICAL" are stacked on top of the letters "KMI" in a larger font. The word "INCORPORATED" is below the letters "KMI".
510(k) KMI Wrist Fusion System KMI Medical Inc., San Diego, CA December 1998
K991873 No 510(k) Number has been issued.
Device Name:
KMI Wrist Fusion System
Indications for Use:
The KMI Wrist Fusion System is comprised of the total wrist fusion plate which is intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones and indicated for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, or rheumatoid arthritis, and the KMI limited wrist fusion plate is intended for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.
(Please do not write below this line. Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the Counter Use
(Per 21 CFR 801.109)
(Optional format 1-2-96)
Russell S. Pyron Jr.