(72 days)
No
The summary describes a mechanical joint replacement system with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is an orthopedic implant for joint replacement, which is a therapeutic intervention, but the device itself is not a therapeutic device in the sense of delivering therapy (e.g., electrical stimulation, drug delivery, light therapy). It is a passive structural component designed to restore function.
No
The device is described as an implant system for joint replacement, intended for intractable pain. Its purpose is to replace joint functionality due to deformity or arthritis, not to diagnose medical conditions.
No
The device description explicitly lists physical components (radial implant, carpal plate implant, carpal polymer component, bone screws) made of materials with a clinical history, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for treating intractable pain and replacing joint functionality in the wrist due to various arthritic conditions and trauma. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a surgical implant system (radial implant, carpal plate, polymer component, screws) designed to be surgically implanted and cemented into the wrist joint. This is consistent with a medical device used for treatment, not for analyzing biological samples to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
In summary, the device is a surgical implant intended for the treatment of wrist joint issues, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KMI Universal Total Wrist™ System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis of the radial/carpal joints. It is intended to replace functionality of the joint due to deformity or elements stated above. It is intended for cemented use only.
Product codes
JWJ
Device Description
The KMI Universal Total Wrist™ (UTW) System (either predicate or modification) consists of the following components: the radial implant, the carpal plate implant, the carpal polymer component and two bone screws. The system is offered in three sizes (small, medium, and large), with three matching polymer component sizes, which are available in varying thicknesses (standard, +1 mm, +2 mm). It is constructed of materials that have a long clinical history of proven acceptance and performance. This system is intended for use with cement and will be promoted as such in the UTW surgical technique manual.
Material Composition
There is no change in material composition of the device, except for addition of a CP Ti porous bead coating to the Ti-6AI-4V carpal plate. The Co-Cr-Mo porous bead coating added to the radial component is of the same material as the component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial/carpal joints
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 Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3800 Wrist joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Modification to the Universal Total Wrist™ System 510(k) Summary .
Page 1 of 2
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Kinetikos Medical, Inc. 4115 Sorrento Valley Blvd. San Diego, CA 92121 Telephone (858) 558-2233 FAX (858) 558-0838
KOJOS54
Official Contact:
John Spampinato
Floyd G. Larson Representative/Consultant: PaxMed International 4329 Graydon Road San Diego, CA 92130 Telephone (858) 792-1235 FAX (858) 792-1236
DEVICE NAME
| Classification Name: | Wrist joint metal/polymer semi-constrained
cemented prosthesis |
|-------------------------|-------------------------------------------------------------------|
| Trade/Proprietary Name: | Universal Total Wrist™ System |
| Common Name: | Wrist Prosthesis |
PREDICATE DEVICE INFORMATION
The principal predicate device for this modification is the Kinetikos Medical Universal Total Wrist™ System, cleared by FDA on June 6, 1996 under K961051.
PACKAGING/LABELING/PRODUCT INFORMATION
Packaging and labeling of the device will be the same as that of the present Universal Total Wrist. The device will continue to be indicated for cemented use only.
1
INTENDED USE
The KMI Universal Total Wrist™ System is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, and trauma-induced osteoarthritis of the radial/carpal joints. It is intended to replace functionality of the joint due to deformity or elements stated above. It is intended for cemented use only.
SYSTEM DESCRIPTION
The KMI Universal Total Wrist™ (UTW) System (either predicate or modification) consists of the following components: the radial implant, the carpal plate implant, the carpal polymer component and two bone screws. The system is offered in three sizes (small, medium, and large), with three matching polymer component sizes, which are available in varying thicknesses (standard, +1 mm, +2 mm). It is constructed of materials that have a long clinical history of proven acceptance and performance. This system is intended for use with cement and will be promoted as such in the UTW surgical technique manual.
Material Composition
There is no change in material composition of the device, except for addition of a CP Ti porous bead coating to the Ti-6AI-4V carpal plate. The Co-Cr-Mo porous bead coating added to the radial component is of the same material as the component.
EQUIVALENCE TO MARKETED PRODUCT
The modification to the UTW has the following similarities to the predicate UTW. which previously received 510(k) concurrence:
- · has the same indicated use.
- · uses the same operating principle,
- · incorporates the same basic design.
- · incorporates the same materials (with the addition of porous coatings), and
- · is packaged and sterilized using the same materials and processes.
In summary, the modification to the Kinetikos Medical Universal Total Wrist™ System described in this submission is, in our opinion, substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing right, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 0 3 2002
Floyd G. Larson Kinetikos Medical Inc. c/o PaxMed International 4329 Graydon Road San Diego, California 92130
Re: K020554
Trade/Device Name: Universal Total Wrist System Regulation Number: 21 CFR §888.3800 Regulation Name: Wrist joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWJ Dated: February 19, 2002 Received: February 20, 2002
Dear Mr. Larson;
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.
3
Page 2 - Mr. Floyd G. Larson
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.
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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
for Mark N Milliken
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
4
Device Name: Universal Total Wrist™ System
020554 page 1 of 1
Indications for Use:
Indicated for intractable pain resulting from traumatic arthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint. To replace functionality of the joint due to deformity or elements stated above. Intended for cemented use only.
for Mark N. Milliken
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number ___ K020554
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use