(84 days)
No
The device description focuses on mechanical components and surgical instrumentation, with no mention of AI, ML, or related concepts.
No
The device is described as a system for reduction and internal fixation of arthrodesis of interphalangeal joints, which is a treatment for a condition rather than a diagnostic or monitoring function typical of many therapeutic devices. Its function is to provide structural support for healing (fusion) rather than actively treating a disease process.
No
Explanation: The device description clearly states its purpose is for "reduction and internal fixation of arthrodesis," which is a treatment or surgical procedure, not a diagnostic one. There is no mention of the device identifying diseases, conditions, or providing information for diagnosis.
No
The device description clearly outlines hardware components (screws, posts, instrumentation like drills, guide wires, etc.) and bench testing related to the mechanical properties of these hardware components. There is no mention of software as a component of this system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Extremity Medical IP Fusion System is a surgical implant and associated instrumentation used for the physical fixation of bones in the hand. It is used in vivo (within the body) during a surgical procedure.
- Intended Use: The intended use is for "reduction and internal fixation of arthrodesis of the interphalangeal joints of the hand," which is a surgical procedure, not a diagnostic test performed on a sample.
The description clearly indicates a device used for surgical intervention and physical support, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Extremity Medical IP Fusion System is intended for reduction and internal fixation of arthrodesis of the interphalangeal joints of the hand.
Product codes
HWC
Device Description
The Extremity Medical IP Fusion System is designed to allow arthrodesis of the interphalangeal joints of the hand. The system has two intra-operative configurations: a cannulated or non-cannulated lag screw, and an intramedullary Post for engaging the lag screw. The Post consists of a threaded cylinder with an eyelet through the head at to accommodate the lag screw. The axis of the eyelet and the lag screw couple at an oblique angle, which forms a reference angle for the intended fusion. The system includes common instrumentation for application of surgical bone screws within the human body, such as drills, guide wires, countersinks, reamers, drill and guide wire guides, and a screwdriver.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interphalangeal joints of the hand
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
Bench testing, including pull-out strength, torque, and static and dynamic bending was performed and compared to the predicate devices. Clinical simulations in cadavers were performed to verify the surgical technique. No clinical testing was performed.
Key Metrics
Not Found
Predicate Device(s)
Kirschner Wires K073674, Osteomed Hand Fusion System K111419, EXTREMITY MEDICAL Screw System, Extremity Medical K121417
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.
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510(k) Summary of Safety and Effectiveness:
EXTREMITY MEDICAL IP Fusion System
APR 1 1 2013
| Submitter: | EXTREMITY MEDICAL
300 Interpace Parkway
Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal
Director, Regulatory Affairs
Phone: (973) 588-8988
Email: bsmekal@extremitymedical.com |
| Date Prepared | March 26, 2013 |
| Trade Name | EXTREMITY MEDICAL IP Fusion System |
| Classification Name
and Number | Smooth or threaded metallic bone fixation fastener
21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Devices | 1. Kirschner Wires K073674
2. Osteomed Hand Fusion System K111419
3. EXTREMITY MEDICAL Screw System, Extremity Medical K121417 |
| Device Description | The Extremity Medical IP Fusion System is designed to allow arthrodesis of
the interphalangeal joints of the hand. The system has two intra-operative
configurations: a cannulated or non-cannulated lag screw, and an
intramedullary Post for engaging the lag screw. The Post consists of a threaded
cylinder with an eyelet through the head at to accommodate the lag screw. The
axis of the eyelet and the lag screw couple at an oblique angle, which forms a
reference angle for the intended fusion. The system includes common
instrumentation for application of surgical bone screws within the human
body, such as drills, guide wires, countersinks, reamers, drill and guide wire
guides, and a screwdriver. |
| Indications for use | The Extremity Medical IP Fusion System is intended for reduction and internal
fixation of arthrodesis of the interphalangeal joints of the hand. |
| Statement of
Technological
Comparison | The EXTREMITY MEDICAL IP Fusion System and its predicate devices
have the same indications for use; have a similar design; are made of similar
materials, and have equivalent mechanical properties. |
| Non-clinical Testing | Bench testing, including pull-out strength, torque, and static and dynamic
bending was performed and compared to the predicate devices. Clinical |
| | simulations in cadavers were performed to verify the surgical technique. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The EXTREMITY MEDICAL IP Fusion System is substantially equivalent to its predicate devices. This conclusion is based upon indications for use, materials, design, test data and principles of operation. |
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complete with the state the states
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized eagle emblem, consisting of three curved lines that resemble the wings and body of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 11, 2013
Extremity Medical, LLC. % Mr. Brian Smekal Director, Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K130120
Trade/Device Name: EXTREMITY MEDICAL IP Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 28, 2013 Received: January 30, 2013
Dear Mr. Smekal:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Mr. Brian Smekal
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.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130120 EXTREMITY MEDICAL IP Fusion System Device Name: Indications for Use:
The Extremity Medical IP Fusion System is intended for reduction and internal fixation of arthrodesis of the interphalangeal joints of the hand.
Prescription Use X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth Lygrank -S
Division of Orthopedic Devices