(47 days)
Not Found
No
The summary describes a standard bone screw system and does not mention any AI or ML components.
Yes
The device is described as assisting in "fixation/stabilization of small bone hand or small bone forefoot fractures," indicating a therapeutic purpose.
No
The device is a bone screw system used for fixation/stabilization of fractures, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a bone screw system made of Ti-6Al-4V ELI, which is a physical implantable medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside of the body (in vitro).
- Device Description: The KMI K2 Bone Screw System™ is described as a system of bone screws made of Ti-6Al-4V ELI, available in different lengths and diameters. These are implantable devices used for the fixation and stabilization of bone fractures.
- Intended Use: The intended use is for "fixation/stabilization of small bone hand or small bone forefoot fractures." This is a surgical procedure performed inside the body.
The description clearly indicates that this is a surgical implant used directly on the patient's bones, not a device used to analyze samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The KMI K2 Bone Screw System™ will be used on indications that are common with presently marketed devices. The indications for use of the K2 Bone Screw System™ are fixation/stabilization of small bone hand or small bone forefoot fractures.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The KMI K2 Bone Screw System™ will be offered in Ti-6Al-4V ELI. It will be available in common styles and assorted lengths for bone fracture fixation and stabilization. Initially, a range of eleven screw lengths will be made available in 2.8 mm diameter (10-30 mm), and eight screw lengths will be made available in the 2.4 mm (6-20 mm) diameter screw. Both screw types are implantable using a standard (e.g. American Orthopedic) hexhead screwdriver, which is cannulated at center.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bone hand or small bone forefoot
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): 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.
K903810, K921622, K931524, K940207, K924018, K792022, K792291
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
§ 888.3040 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.
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(960537
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MAR 2 5 1590
FDA Notification of:
Summary of Safety and Effectiveness Information Product: K2 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 Fixatio
Fastener |
| Common Used Name: | Bone Screw |
| Trade Proprietary Name: | K2 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. The logo is in black and white and features the words "KINETIKOS MEDICAL" in a sans-serif font at the top. Below that is the abbreviation "KMI" in a larger, bolder font. The word "INCORPORATED" is printed in a smaller font below the abbreviation.
( onfidential
FDA Notification of:
Summary of Safety and Effectiveness Information Product: K2 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 K2 Bone Screw System™ will be offered in Ti-6Al-4V ELI. It will be available in common styles and assorted lengths for bone fracture fixation and stabilization. Initially, a range of eleven screw lengths will be made available in 2.8 mm diameter (10-30 mm), and eight screw lengths will be made available in the 2.4 mm (6-20 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 K2 Bone Screw System™ will be used on indications that are common with presently marketed devices. The indications for use of the K2 Bone Screw System™ are fixation/stabilization of small bone hand or small bone forefoot fractures.
2
Image /page/2/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated. The logo is in black and white and features the letters KMI in large, bold font. Above the letters, the word "KINETIKOS MEDICAL" is written in a smaller font. Below the letters, the word "INCORPORATED" is written in a smaller font.
FDA Notification of:
Summary of Safety and Effectiveness Information Product: K2 Bone Screw System™
Confidential
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 K2 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.
3
Image /page/3/Picture/0 description: The image shows the logo for Kinetikos Medical Incorporated. The logo is in black and white and features the letters "KMI" in a large, bold font. Above the letters is the word "KINETIKOS MEDICAL" and below the letters is the word "INCORPORATED". The logo is simple and professional.
Image /page/3/Picture/1 description: The image contains the words "FDA Notification of:". The text is in bold font. The text is centered on the image.
Summary of Safety and Effectiveness Information Product: K2 Bone Screw System™
Confidential
Instrumentation:
KMI K2 Bone Screw System™ instrumentation used for the preparation and insertion of the K2 Bone Screws is considered to be general orthopaedic instrumentation. The system includes standard manual orthopaedic surgical instruments of the appropriate size and type. All K2 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 K2 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.