(47 days)
Not Found
No
The description focuses on the mechanical properties and intended use of a bone screw, with no mention of AI or ML.
Yes.
The device is used for the treatment of bone fractures, which is a therapeutic purpose.
No
The device is a medical screw used for treating bone fractures, not for diagnosis. Its intended use describes treatment, not the identification of a disease or condition.
No
The device description clearly describes a physical bone screw, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The IFS Cannulated Bone Screw is a physical implantable device used to fix bone fractures. It is surgically inserted into the body.
- Intended Use: The intended use clearly describes a surgical procedure to treat bone fractures, not the analysis of biological samples.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Intended Use of the IFS Cannulated Bone Screw is for the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot.
Product codes
HWC
Device Description
The IFS Cannulated Screw is a self-tapping, self-drilling screw with a cancellous thread that can be guided into position by guidewire placement. Partial or fully threaded screws are available in 3.0mm, 3.5mm, and 4.0mm thread diameters and 10mm to 75mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot (specifically tarsals, metatarsals, and phalangeal)
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)
K050754, K053394, K990776, K042310, K991151, K991197
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
K@6162@
Ps 1 of 2
Image /page/0/Picture/1 description: The image shows a logo for Internal Fixation Systems. The logo consists of the letters IFS in a stylized font. A vertical line runs through the letters, with a spring-like design on the left side of the line. The words "INTERNAL FIXATION SYSTEMS" are printed in a smaller font below the letters.
JUL 2 6 2006
5619 N.W. 74th Avenue, Miami, Florida 33166
Internal Fixation Systems, Inc. 510(k) Summary
| Company Name: | Internal Fixation Systems, Inc.
5619 N.W. 74th Avenue
Miami, Florida 33166 | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------|--------------------|
| Contact Name: | Steve Hernandez
5619 N.W. 74th Avenue
Miami, Florida 33166
Phone (305) 216-4766
Fax (305) 887-7340 | | |
| Trade Name: | IFS Cannulated Bone Screw | | |
| Common Name: | Cannulated Bone Screw | | |
| Regulation Name: | Smooth or Threaded Metallic Bone Fixation Fastener | | |
| Regulation Number: | 21 CFR 888.3040 | | |
| Regulatory Class: | II | | |
| Device Product
Code: | HWC | | |
| Substantially
Equivalent Devices: | Manufacturer | Trade Name | 510(k) Number |
| | Precimed, Inc. | Precimed Cannulated
Screw System | K050754 |
| | Nexa Orthopedics | Nexa Bone Screw System | K053394 |
| | aap Implants, Inc. | aap Cannulated Screw | K990776 |
| | Ortho-Pro LLC | Cannulated Bone Screws | K042310 |
| | Vilex, Inc. | Vilex Cannulated Screws | K991151
K991197 |
Device Description:
The IFS Cannulated Screw is a self-tapping, self-drilling screw
1
Image /page/1/Picture/0 description: The image shows a logo with the letters IFS in a stylized font. The letters are connected by horizontal lines at the top and bottom. A vertical line runs through the left side of the letters, with a zigzag pattern on the left side of the line. Below the letters, the words "INTERNAL FIXATION SYSTEMS" are written in a smaller font.
5619 N.W. 74th Avenue, Miami, Florida 33166
with a cancellous thread that can be guided into position by guidewire placement. Partial or fully threaded screws are available in 3.0mm, 3.5mm, and 4.0mm thread diameters and 10mm to 75mm in length.
The intended use of the IFS Cannulated Bone Screw is for the Intended Use: treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot.
| Item | Internal Fixation Systems, Inc. | Precimed, Inc |
|---|---|---|
| Product Name | IFS Cannulated Bone Screw | Precimed Cannulated Screw System |
| Use | Single Use | Single Use |
| Fixation Type | Screw | Screw |
| Material | 316L | 316L |
| Sizes | Various diameters and lengths for small bone fractures | Various diameters and lengths for small bone fractures |
| Indications for Use | The IFS Cannulated Bone Screw is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot. | The Precimed Cannulated Screw System is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot. |
Technological The IFS Cannulated Bone Screws are substantially equivalent to Characteristics the predicate devices with respect to design, material, and Comparison: indications for use.
Sterilization IFS Cannulated Bone Screws (devices) will be distributed nonsterile. The devices are sterilized by the end user per the AAMI Information: Guidelines "Good Hospital Practice: Steam Sterilization and Sterility Assurance" and ANSI/AAMI/ISO 11737 guidelines to achieve the Sterility Assurance Level (SAL) of 10 °.
- Conclusion: There are no significant differences between the Precimed Cannulated Screw System and the other devices as listed in the Substantially Equivalent Devices. The IFS device and the predicate devices have similar design attributes, material, and intended use thus is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2006
Internal Fixation Systems, Inc. % Mr. Steve Hernandez President 5619 N.W. 74th Avenue Miami, Florida 33166
Re: K061620
Trade/Device Name: IFS Cannulated Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 6, 2006 Received: June 9, 2006
Dear Mr. Hernandez:
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. Iisting 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 mav 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
Page 2 -- Mr. Steve Hernandez
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: IFS Cannulated Bone Screw
Indications For Use: The Intended Use of the IFS Cannulated Bone Screw is for the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices and Neurological Devices Page 1 of