Indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, rheumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint. To replace functionality of the joint due to deformity or elements stated above. The Universal Total Wrist is intended for cemented use.

Device Description

The KMI Universal Total Wrist (UTW) System (both predicate and extra small) consists of the following components: the radial implant, the carpal plate implant, the carpal polymer component, and two bone screws. The system will now be offered in 4 (four) sizes: 'extra small', 'small', 'medium' and 'large'), each with 3 (three) matching polymer component sizes, which are available in yarvina thicknesses (height); standard, +1 and + 2, 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 Protocol.

AI/ML Overview

Here's an analysis of the provided text regarding the Universal Total Wrist System, focusing on acceptance criteria and supporting studies:

Based on the provided documents, this 510(k) submission (K030037) is a Special 510(k) Notification for a modification to an already cleared device, the Universal Total Wrist System. Specifically, it's for introducing an "extra small" size. Special 510(k)s often rely heavily on demonstrating substantial equivalence to a predicate device and may not involve extensive new clinical or performance studies in the same way a novel device might.

Therefore, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the traditional sense (e.g., performance metrics with defined thresholds for a new device) is not directly applicable or explicitly detailed in these documents for the modified device. Instead, the "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to the predicate device. The "study" is more accurately described as a comparison and analysis against the predicate.

Here's the breakdown of the information as requested, tailored to the context of a Special 510(k) for a size modification:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

Acceptance Criteria (Demonstrated Equivalence to Predicate)	Reported Device Performance (Extra Small Universal Total Wrist System)
Identical Design to predicate UTW implants (small, medium, large).	The extra small size has an identical design to the predicate Universal Total Wrist System (K961051, K020554).
Identical Materials to predicate UTW implants.	The extra small size is constructed of identical materials as the predicate.
Identical Operating Principle to predicate UTW implants (functioning as a wrist joint metal/polymer prosthesis).	The extra small size has an identical operating principle as the predicate, providing wrist joint replacement.
Identical Packaging and Sterilization Materials and Processes to predicate UTW implants.	The extra small size is packaged and sterilized using identical materials and processes as the predicate.
Intended Use consistent with predicate (replacing functionality due to intractable pain from various arthropathies).	The extra small size is indicated for the same intended use as the predicate: intractable pain from traumatic arthritis, osteoarthritis, rheumatoid arthritis, or trauma-induced osteoarthritis of the radial/carpal joint, for cemented use.

Study Details (Comparison for Substantial Equivalence)

Sample size used for the test set and the data provenance:
- Test Set: No clinical test set in the traditional sense is described. The "test set" for this submission consists of the engineering drawings and specifications of the "extra small" implant.
- Data Provenance: The comparison is based on the design specifications and material properties of the new "extra small" component and the previously cleared "small" (predicate) component. The provenance is internal manufacturing and design data from Kinetikos Medical, Inc. This is a retrospective comparison against an already cleared predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- No external experts were explicitly mentioned as being used to establish "ground truth" for this engineering comparison. The "ground truth" for the comparison is the design and material specifications of the predicate device, which were previously reviewed and cleared by the FDA. The manufacturer's internal engineering and quality assurance personnel would have performed the comparison.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method in the context of expert review is described. The comparison relies on documented specifications. The FDA's review process itself acts as an adjudication that the presented information supports substantial equivalence.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a mechanical implant (wrist prosthesis), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers/AI is irrelevant and was not conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is the already established and FDA-cleared design, material, manufacturing, and performance characteristics of the predicate Universal Total Wrist System. The "extra small" size is demonstrating conformity to these established truths by being "identical" in all key aspects except size.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not a learning algorithm. The "training" for the predicate device would have involved a long clinical history of similar materials and designs, as explicitly stated: "It is constructed of materials that have a long clinical history of proven acceptance and performance." This refers to general knowledge about medical-grade materials, not a specific training dataset for this device.
How the ground truth for the training set was established:
- Not applicable. As above, there's no "training set." The "ground truth" for the overall device's safety and effectiveness (as represented by the predicate) was established through previous FDA clearances based on established standards, material properties, mechanical testing, and clinical history of similar devices.

Summary

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K030037

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ADMINISTRATIVE INFORMATION

Manufacturer Name:	Kinetikos Medical, Inc.6005 Hidden Valley RoadCarlsbad, CA 92009Telephone (858) 558 2233FAX (858) 558 0838	FEB 05 2003
Official Contact	John Spampinato
Representative	John Spampinato, V. P., Quality AssuranceKinetikos Medical, Inc.6005 Hidden Valley RoadCarlsbad, CA 92009Telephone (858) 558 2233 # 406FAX (858) 558 0838
DEVICE NAME
Classification Name:	Wrist joint metal/polymer semi-constrained cementedProsthesis
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 -sizes Small, Medium and Large- originally cleared by FDA on June 6, 1996 under K961051, and modified system version cleared May 03, 2002 under K020554.

PACKAGING/LABELING/PRODUCT INFORMATION

Packaging and labeling of the device will be the same as that of the predicate Universal Total Wrist. The device will continue to be indicated for cemented use only. Samples of a package label, product brochure and the surgical technique manual with draft changes in product illustrations, are shown in Exhibit II.

INTENDED USE

The Extra Small KMI Universal Total Wrist implant is indicated for intractable pain resulting from traumatic arthritis, osteoarthritis, theumatoid arthritis, trauma-induced osteoarthritis of the radial/carpal joint. To replace functionality of the joint due to deformity or elements stated above. The Universal Total Wrist is intended for cemented use.

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30037

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Special 510(k) Notification - Modification to the Universal Total Wrist System - Page 2

SYSTEM DESCRIPTION

EQIVALENCE TO MARKETED PRODUCT

The size extra small has the following similarities to the predicate UTW implants which previously received 510(k) concurrence:

-identical design
-identical materials
-identical operating principle
-is packaged and sterilized using identical materials and processes

Its one distinct difference is that the size extra small is 9% smaller than the size small. In summary, the extra small Universal Total Wrist System described in this submission is, in our opinion, substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to symbolize the department's focus on people. The figure is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2003

Mr. John Spampinato V.P., Quality Assurance Kinetikos Medical, Inc. 6005 Hidden Valley Road, Suite 180 Carlsbad, California 92009

Re: K030037

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: December 31, 2002 Received: January 6, 2003

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 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 - Mr. John Spampinato

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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the 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 N. Melkman

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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K030037

Special 510(k) Notification

Device Name: Universal Total Wrist System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONITINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

for Mark N. Millman

eral, Restorative and Neurological Devices

510(k) Number K030037
2 OF 9

Regulation Number and Section

§ 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.