(231 days)
No
The summary describes a physical implant for bone fusion and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an implant designed for small bone fusion and fractures in fingers, toes, and small bones, which is a therapeutic purpose.
No
The device description states it is a "single piece metal implant that is surgically inserted into the intramedullary canal of the bones... designed to create a fusion," which indicates a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "single piece metal implant that is surgically inserted," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The iFuse Hammertoe system is a surgical implant designed to be inserted directly into the bones of the body. It is a physical device used for fusion and fracture repair, not a test performed on a sample outside the body.
- Intended Use: The intended use is for "small bone fusion and fractures," which is a surgical procedure, not a diagnostic test.
Therefore, the iFuse Hammertoe system falls under the category of a surgical device or implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The iFuse Hammertoe system is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.
Product codes
HWC
Device Description
The iFUSE Hammertoe System by OrthoPro is a single piece metal implant that is surgically inserted into the intramedullary canal of the bones in the toe, finger or small bones, designed to create a fusion.
Materials: Ti-6AL-4V-ELI per ASTM F136
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones in the toe, finger or small bones
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)
The following testing was performed:
- Pullout strength
- . Four point bending and fatigue strength
The results of this testing indicate that the iFUSE Hammertoe System is equivalent to predicate devices.
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Legally Marketed Stayfuse, Pioneer Surgical Technology, K990804, OthoPro Stemman Pins and Kirschner Wires, OrthoPro LLC, K070555
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.113006
510(k) Summary for the iFUSE Hammertoe System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the iFUSE Hammertoe System
1. GENERAL INFORMATION
| Date Prepared: October 3, 2011 |
|---|
| Trade Name: iFUSE Hammertoe System |
| Common Name: screw, fixation, bone |
| Classification Name: Smooth or threaded metallic bone fixation fastener |
| Class: II |
| Product Code: HWC |
| CFR section: 21 CFR section 888.3040 |
| Device panel: Orthopedic |
| Legally Marketed Stayfuse, Pioneer Surgical Technology, K990804 |
| Predicate Device: OthoPro Stemman Pins and Kirschner Wires, OrthoPro LLC, K070555 |
| Submitter: OrthPro, LLC |
| 3450 S Highland Dr. |
| Salt Lake City, Utah 84106 |
| Contact: J.D. Webb |
| 1001 Oakwood Blvd |
| Round Rock, TX 78681 |
| 512-388-0199 |
| e-mail: ortho.medix@sbcglobal.net |
2. DEVICE DESCRIPTION
The iFUSE Hammertoe System by OrthoPro is a single piece metal implant that is surgically inserted into the intramedullary canal of the bones in the toe, finger or small bones, designed to create a fusion.
Materials: Ti-6AL-4V-ELI per ASTM F136
SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES 3.
The iFUSE Hammertoe System is substantially equivalent to the predicate device in terms of intended use, design, materials used, mechanical safety and performances.
INTENDED USE 4.
The iFuse Hammertoe system is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.
NON-CLINICAL TEST SUMMARY 5.
The following testing was performed:
- Pullout strength ●
- . Four point bending and fatigue strength
The results of this testing indicate that the iFUSE Hammertoe System is equivalent to predicate devices.
CLINICAL TEST SUMMARY 6.
No clinical studies were performed.
CONCLUSIONS NONCLINICAL AND CLINICAL 7.
The conclusions drawn from the comparison between the devices demonstrate that the iFUSE Hammertoe System is as safe, as effective, and performs as well as the predicate devices.
p. lcfi
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 5 2012
OrthoPro LLC % The OrthoMedix Group, Incorporated Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K113006
Trade/Device Name: I-Fuse Hammer Toe Systems Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 4, 2012 Received: April 10, 2012
Dear Mr. Webb:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 r hat 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 or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Of ice rated adverse events) (21 CFR 803); 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. J.D. Webb
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default:htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eunel Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
K11 3006 · 510(k) Number (if known):
Device Name: _ I-Fuse Hammer Toe System
Indications for Use:
The iFuse Hammertoe system is designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.
Prescription Use __X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Sst
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number k 113006
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