(87 days)
The KMI Universal Total Wrist™ System is indicated for intractable pain resulting from traumatic arthritis, osteo arthritis, theumatoid arthritis, trauma induced osteo arthritis of the radial / Carpal joint. To replace functionality of the joint due to deformity or elements stated above.
The KM1 will be offered in three sizes (small, medium, and large) with the poly bearing implant also offered in three sizes to match the carpal plate implants. The Universal total Wrist implant 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
The provided text describes a medical device, the Universal Total Wrist™ System, and its regulatory submission to the FDA. However, it does not contain information about acceptance criteria for the device's performance in a study, nor does it detail any specific study that proves the device meets such criteria.
The document focuses on:
- Regulatory Information: Company details, classification, and substantial equivalence to other existing devices.
- Device Description: Materials used (meeting ASTM standards), sizes, indication for use, and sterilization methods.
- Performance Standards: It explicitly states, "No performance standards applicable to semi-constrained wrist implant have been established by the FDA." It then mentions that the materials used (titanium alloy, CrCoMo) meet chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM).
- Summary: Highlights the long clinical history of similar wrist implant systems and the understanding of their uses, indications, and limitations.
Therefore, I cannot provide the requested table or details about a study demonstrating acceptance criteria because this information is not present in the provided text.
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JUN - 6 1996
Image /page/0/Picture/3 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 located below the letters "KMI".
Confidential
FDA Notification of:
Summary of Safety and Effectiveness Information Product: Universal Total Wrist™ System
Summary of Safety and Effectiveness Information a
For Release Upon Request Only
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807 92
Company Name / Contact:
| Company: | KMI (Kinetikos Medical Inc.)3950 Sorrento Valley BlvdSan Diego, Ca 92120 | |
|---|---|---|
| Contact: | Regulatory Affairs DepartmentKMI3950 Sorrento Valley BlvdSan Diego, Ca 92110(619) 558-2233 | |
| Establishment Registration Number: | 2028840 | |
| Classification Name: | Wrist Prosthesis ( metal/plastic/metalsemi-constrained ), 87JWJ | |
| Common Used Name: | Wrist Prosthesis | |
| Trade Proprietary Name: | Universal Total Wrist™ System |
The FDA has classified similar products as a Class II device by the Orthopedic Device Section of the Surgical and Rehabilitation Devices Panel at Section 888-304. The product code generally refereed to is 87JWJ ( Product Code: JWJ ) , and KMI submits this application under this designation.
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Image /page/1/Picture/3 description: The image shows the logo for Kinetikos Medical Incorporated. The logo is in black and white and features the words "KINETIKOS MEDICAL" in a serif font at the top. Below that is a large, stylized "KMI" and the word "INCORPORATED" in a smaller serif font.
Confidential
FDA Notification of:
Summary of Safety and Effectiveness Information Product: Universal Total Wrist™ System
Performance Standards:
No performance standards applicable to semi-constrained wrist implant have been established by the FDA. However, the titanium alloy 6AL-4V ELI alloy used to manufacture the carpal plate implant meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84) Additionally, the CrCoMo used in the radial implant per ASTM F-75-87 meets the chemical and mechanical requirements of the voluntary standards established by the American Society for Testing and Materials (ASTM 136-84, B 800-74).
Package and Labeling:
Draft Package labeling has been developed and enclosed in Section 2 attachments. A draft package insert has also been developed and enclosed in Section 2 for your review and consideration.
System Description:
The KM1 will be offered in three sizes (small, medium, and large) with the poly bearing implant also offered in three sizes to match the carpal plate implants. The Universal total Wrist implant 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
Indications for Use:
The KMI Universal Total Wrist™ System is indicated for intractable pain resulting from traumatic arthritis, osteo arthritis, theumatoid arthritis, trauma induced osteo arthritis of the radial / Carpal joint. To replace functionality of the joint due to deformity or elements stated above.
Substantial Equivalent Devices:
This product is substantially equivalent in design, composition and/or function to other orthopedic implant devices manufactured and approved for market.
| Protek Meuli Wrist: | K |
|---|---|
| Howmedica AMC Wrist: | K |
| Depuy Bi-Axial Wrist: | K |
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Image /page/2/Picture/1 description: The image shows the text 'P. 4' in a simple, sans-serif font. The 'P' is capitalized and followed by a period, and then a space separates it from the number '4'. The text is likely a page number or a reference to a specific section within a document.
Image /page/2/Picture/2 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 located below the letters "KMI".
Confidential
FDA Notification of:
Summary of Safety and Effectiveness Information Product: Universal Total Wrist124 System
Instrumentation:
KMI Universal Total Wrist™ system instrumentation used for the preparation and insertion of the UTW implants is considered to be general orthopaedic instrumentation. The system includes standard manual orthopaedic surgical instruments of the appropriate size and type. All Universal Total Wrist System instruments are manufactured from stainless steel meeting ASTM F899-84 standards.
Product Stcrilization:
K.MI will supply all implants Sterile. The product will be sterilized by Gamma radiation. The minimum dosage will be 25Kgy with a maximum of 45Kgy. Validation of the product will be made to ensure a sterile assurance level (SAL) of 10-6 per AMMI standard guidelines.
Summary:
Substantial Equivalence for the KMI Universal Total Wrist™ system may be found in companson with devices from a number of manufactures. Wrist implant systems in general have been used for many years, and the clinical performance is well known and documented in the body of this submission
Another measure of the Safety and Effectiveness of a medical device is how it performs in long term use. The basic design concept of replacing the weakened bone anatomy of the wrist for relief from traumatic arthritis, osteo arthritis, and rheumatoid arthritis has over 20 years of clinical evaluation. Uses, Indications, limitations and surgical techniques are well understood. Standardized manufacturing methods, design practices, material selections and testing techniques are known and represented within the guidelines of this submittal.
§ 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.