(37 days)
K915818, Preamendment device
Not Found
No
The summary describes a mechanical implant (rigid bar and screws) for wrist fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended for wrist arthrodesis to treat conditions like osteoarthritis and fractures, which are medical conditions, and aims to restore function and alleviate pain.
No
Explanation: The device is a surgical implant designed for wrist fusion. Its purpose is to provide fixation of bones, not to diagnose a condition.
No
The device description explicitly states it consists of a rigid bar and screws made of stainless steel, indicating it is a physical implant and not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for wrist arthrodesis, which is a surgical procedure to fuse bones in the wrist. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a rigid bar and screws made of stainless steel, designed for physical fixation of bones. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The KMI Wrist Fusion System is a medical device used in the body for structural support and fixation.
N/A
Intended Use / Indications for Use
KMI Wrist Fusion System 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The KMI Wrist Fusion System consists of a rigid bar measuring 77.47 mm in length with holes to accommodate specific screws and the screws, both 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, small bones such as the radius and carpal bones
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.
Synthes Titanium Small Reconstruction Plate-K915818, Synthes 3.5 mm Dynamic Compression Plate-a Preamendment device
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.
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"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
- Submitter's name, address, telephone and fax number: 1. Kinetikos Medical Inc. 4115 Sorrento Valley Road San Diego. CA 92121 FAX: 619-558-0838 Telephone: 619-558-2233 Michael Collins, Director of Engineering Contact Person: January 7, 1999 Date Summary Prepared: 2. Name of Device: KMI Wrist Fusion System Proprietary Name: Plate, fixation, bone Common/Usual Name: Plate, fixation, bone Classification Name: Predicate Device: Synthes Titanium Small Reconstruction Plate-K915818, and 3. Synthes 3.5 mm Dynamic Compression Plate-a Preamendment device
Description of Device: 4.
The KMI Wrist Fusion System consists of a rigid bar measuring 77.47 mm in length with holes to accommodate specific screws and the screws, both manufactured of 316L stainless steel.
- ડ. Intended Use: KMI Wrist Fusion System 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, while the Synthes Titanium Small Reconstruction Plate is intended for fixation of small bones such as the radius, ulna and fibula. These intended uses are substantially equivalent and do not affect safety or effectiveness.
- Technological Characteristics: The Synthes Titanium Small Reconstruction Plates ર્શ્વ રહે (K915818) are metal plates with holes for fixation of fractures of small bones and the KMI Wrist Fusion System is a metal plate with holes for wrist arthrodesis, providing fixation of small bones. The only difference is that the KMI System is manufactured of 316L stainless steel. The Synthes preamendment 3.5 mm Dynamic Compression Plate is manufactured of 316L stainless steel and consists of a metal plate with holes. There are no technological characteristics that raise new issues of safety or effectiveness.
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Summary of Safety and Effectiveness for the KMI™ Wrist Fusion System page 2 of 2
- Summary of Performance Date: Not applicable. 7.
- Conclusions Drawn from Nonclinical and Clinical Tests: Not applicable. 8.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 1999
Michael Collins, M.S. Director of Engineering Kinetikos Medical, Inc. (KMI) 4115 Sorrento Valley Boulevard San Diego, California 92121
Re: K990094 KMI Wrist Fusion System Trade Name: Requlatory Class: II Product Codes: HRS and HWC Dated: January 7, 1999 Received: January 12, 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, 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 requlations.
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Page 2 - Michael Collins, M.S.
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.
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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
2 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
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510(k) KMI™ Wrist Fusion System Kinetikos Medical Inc., San Diego, CA January 8, 1999
No 510(k) Number has been issued.
KMI™ Wrist Fusion System Device Name:
Indications for Use:
The KMI Wrist Fusion System is 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.
(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)
(Division Sign-Off) Division of General Restorative De 510(k) Number