(47 days)
The indications for use of the K3 Bone Screw System™ are fixation/stabilization of small bones in hand or small bones in mid and forefoot fractures.
The KMI K3 Bone Screw System'™ will be offered in Ti-6AI-4V ELI. It will be available in common styles and assorted lengths for bone fracture fixation and stabilization. Initially, a range of fifthteen screw lengths will be made available in 3.5 mm diameter (12-50 mm), and eight screw lengths will be made available in the 3.5 mm solid (12-26 mm) diameter screw. Both screw types are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated at center.
The provided text describes the K3 Bone Screw System™ and details its intended use, regulatory standing, and comparison to existing devices. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria.
Instead, the document focuses on:
- Substantial Equivalence: The primary "proof" offered is that the K3 Bone Screw System™ is substantially equivalent to other orthopedic screws already on the market and approved by the FDA. This is a regulatory pathway for devices that are very similar to already legally marketed devices.
- Voluntary Standards: The material (titanium alloy 6AL-4V ELI) used to manufacture the screws meets chemical and mechanical requirements specified in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84, ASTM B348-83, F136-84, F67-88). The instruments are manufactured from stainless steel meeting ASTM F899-84 standards.
- Clinical History: It highlights that bone screw systems in general have been used for many years, and their clinical performance is well known and documented over 75 years of clinical evaluation.
Therefore, I cannot fill out the requested table and answer the study-specific questions as the document does not contain that information. It does not describe a performance study with specific acceptance criteria, sample sizes, expert involvement, or comparative effectiveness.
The document's purpose is to satisfy an FDA Notification for a Summary of Safety and Effectiveness Information, primarily by demonstrating substantial equivalence, not by presenting a performance study with specific, quantifiable acceptance criteria and results.
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Image /page/0/Picture/0 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".
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Confidential
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FDA Notification of:
MAR 2 5 1996
Summary of Safety and Effectiveness Information Product: K3 Bone Screw System™
Summary of Safety and Effectiveness Information
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 Blvd San Diego, Ca 92110
- Contact: Regulatory Affairs Department KMI 3950 Sorrento Valley Blvd San Diego, Ca 92110 (619) 558-2233
Establishment Registration Number: 2028840
| Classification Name: | Smooth or Threaded Bone FixationFastener |
|---|---|
| Common Used Name: | Bone Screw |
| Trade Proprietary Name: | K3 Bone Screw 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 HWC ( Product Code: HWC ) , and KMI submits this application under this designation.
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Image /page/1/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated, with the acronym KMI in large, bold letters. The words "KINETIKOS MEDICAL" are printed above the acronym, and the word "INCORPORATED" is printed below. The logo is black and white.
Confidential
FDA Notification of:
Summary of Safety and Effectiveness Information Product: K3 Bone Screw System™
Performance Standards:
No performance standards applicable to the Bone Screw have been established by the FDA. However, the titanium alloy 6AL-4V ELI alloy used to manufacture the KMI screws meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F136-84).
Package and Labeling:
Package labeling has been developed to industry standards. Packaging is also standard commercially available type quality and is stored in a fashion which prevents damage to the container or package the device is in.
System Description:
The KMI K3 Bone Screw System'™ will be offered in Ti-6AI-4V ELI. It will be available in common styles and assorted lengths for bone fracture fixation and stabilization. Initially, a range of fifthteen screw lengths will be made available in 3.5 mm diameter (12-50 mm), and eight screw lengths will be made available in the 3.5 mm solid (12-26 mm) diameter screw. Both screw types are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated at center.
Indications for Use:
The KMI K3 Bone Screw System™ will be used on indications that are common with presently marketed devices. The indications for use of the K3 Bone Screw System™ are fixation/stabilization of small bones in hand or small bones in mid and forefoot fractures.
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Image /page/2/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated. The words "KINETIKOS MEDICAL" are stacked on top of the letters "KMI", which are in a larger font. The word "INCORPORATED" is stacked below the letters "KMI".
Confidential
FDA Notification of:
Summary of Safety and Effectiveness Information Product: K3 Bone Screw System™
Substantial Equivalent Devices:
This product is substantially equivalent in design, composition and function to other orthopedic screws manufactured and approved for market.
| Ace Medical Company: | K903810 |
|---|---|
| Alphatec Medical: | K921622 |
| Howmedica: | K931524 |
| Aesculap: | K940207 |
| Osteomed: | K924018 |
| Zimmer: | K792022 |
| A.O. Synthes | K792291 |
| Johnson & Johnson | K? |
| ISI Manufacturing | K? |
The KMI K3 Bone Screw System™ meet the ASTM standards (ASTM B348-83, F136-84, F67-88) for material and design for medical application. The bone screws are of the same thread configuration and length as offered by Ace Medical, A.O. Synthes, Zimmer, Johnson & Johnson, Alphatec and many other orthopaedic companies. The minor and major diameters as well as the head size are comparable
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Image /page/3/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated, or KMI. The letters KMI are in a large, bold font. Above the letters is the text "KINETIKOS MEDICAL", and below the letters is the text "INCORPORATED".
Confidential
FDA Notification of:
Summary of Safety and Effectiveness Information Product: K3 Bone Screw System™
Instrumentation:
KMI K3 Bone Screw System™ instrumentation used for the preparation and insertion of the K3 Bone Screws is considered to be general orthopaedic instrumentation. The system includes standard manual orthopaedic surgical instruments of the appropriate size and type. All K3 System instruments are manufactured from stainless steel meeting ASTM F899-84 standards.
Product Sterilization:
KMI will supply all instruments and implants Non-Sterile. Non-Sterile implants are packaged in "clean only" condition. The labeling of the implants and instruments clearly indicates their sterility status. The package insert contains a sterilization/re-sterilization guideline.
Summary:
Substantial Equivalence for the KMI K3 Bone Screw System™ may be found in comparison with devices from a number of manufactures. Bone Screw systems in general have been used for many years, and the clinical performance is well known and documented.
Another measure of the Safety and Effectiveness of a medical device is how it performs in long term use. The basic design concept of bone screws for use in the fixation and stabilization of fractures has had over 75 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.
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.