(191 days)
Not Found
No
The summary describes a mechanical intramedullary nail system for fracture fixation and does not mention any AI or ML components.
No
The device is an intramedullary nail system used for the mechanical fixation of femoral fractures, which is a supportive and structural role rather than a therapeutic one that directly treats a disease or condition.
No
Explanation: The device description clearly states "The ITST Intertrochanteric/ Subtrochanteric Fixation System is used for closed nailing of the femur." This describes a surgical implant used for fixing bone fractures, which is a therapeutic function, not a diagnostic one. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description explicitly lists hardware components such as intramedullary nails, lag screws, anti-rotation screws, cortical screws, and nail caps, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for fixing femoral fractures. This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details surgical implants (nails, screws) used to stabilize bones. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the ITST Intramedullary Nail is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as:
- Subtrochanteric Fractures
- Intertrochanteric Fractures
- Comminuted Fractures
- Segmental Fractures
- Fractures with Bone Loss
- Proximal and Distal Fractures
- Nonunions
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The purpose of this submission is to obtain clearance for a line extension to add 4.5mm Cortical Screws to the ITST system. The ITST Intertrochanteric/ Subtrochanteric Fixation System is used for closed nailing of the femur. The system includes femoral intramedullary nails, lag strews, anti-rotation screws, cortical screws and nail caps. Cortical screws are used for distal locking of the nail.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral
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)
Non-Clinical Performance and Conclusions:
Shelf Life - Accelerated aging testing conducted shows that the sterile devices included in this submission have a shelf life of 10 years.
Biocompatibility – Biocompatibility testing of the subject devices was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
Performance Evaluation -The dimensional evaluation demonstrated that the subject ITST 4.5mm Cortical Screws are safe and effective and substantially equivalent to the predicate M/DN 4.2mm Cortical Screws.
Conclusions: The data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject ITST devices will perform in a substantially equivalent manner to the predicate devices.
Clinical Performance and Conclusions:
Clinical trial data and conclusions were not needed for these devices to show substantial equivalence.
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.
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and well-being. The logo is simple, clean, and easily recognizable.
May 29, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Incorporated Mr. Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
Re: K143321
Trade/Device Name: ITST® Intertrochanteric/Subtrochanteric Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: April 27, 2015 Received: April 29, 2015
Dear Mr. McKelvey:
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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143321
Device Name
ITST® Intertrochanteric/Subtrochanteric Fixation System
Indications for Use (Describe)
The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as:
- · Subtrochanteric Fractures
- · Intertrochanteric Fractures
- Comminuted Fractures
- · Segmental Fractures
- · Fractures with Bone Loss
- Proximal and Distal Fractures
- Nonunions
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a blue letter Z inside of a blue circle. Below the circle is the word "zimmer" in a lowercase, sans-serif, blue font.
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
510(k) Summary
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey, MA, RAC
Senior Project Manager, Regulatory Affairs
Telephone: 574-372-4944
Fax: (574) 372-4605 |
| Date: | November 18, 2014 |
| Trade Name: | ITST® Intertrochanteric/Subtrochanteric Fixation System |
| Common Name: | Rod. Fixation, Intramedullary and Accessories |
| Classification Names
and References: | Intramedullary fixation rod
(21 CFR 888.3020, HSB) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | M/DN® Intramedullary Fixation, manufactured by Zimmer
(K142281, cleared October 22, 2014). |
| Purpose and Device
Description: | The purpose of this submission is to obtain clearance for a
line extension to add 4.5mm Cortical Screws to the ITST
system. The ITST Intertrochanteric/ Subtrochanteric
Fixation System is used for closed nailing of the femur.
The system includes femoral intramedullary nails, lag
strews, anti-rotation screws, cortical screws and nail caps.
Cortical screws are used for distal locking of the nail. |
| Intended Use: | The ITST Intramedullary Nail is indicated for use in a
variety of femoral fractures, such as: Subtrochanteric
Fractures, Intertrochanteric Fractures, Comminuted
Fractures, Segmental Fractures, Fractures with Bone Loss,
Proximal and Distal Fractures, and Nonunions |
4
| Comparison to Predicate Devices: | Both the subject ITST 4.5mm and predicate M/DN 4.2mm
devices are cortical screws with similar diameters. The
subject ITST 4.5mm Cortical Screws have identical
lengths to the predicate M/DN 4.2mm Cortical Screws.
Both devices are made from the same material and have
indications for use. |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Shelf Life - Accelerated aging testing conducted
shows that the sterile devices included in this
submission have a shelf life of 10 years.Biocompatibility – Biocompatibility testing of the
subject devices was conducted per ISO 10993-1 and
Good Laboratory Practices (21 CFR 58). All testing
passed.Performance Evaluation -The dimensional |
- evaluation demonstrated that the subject ITST 4.5mm Cortical Screws are safe and effective and substantially equivalent to the predicate M/DN 4.2mm Cortical Screws.
Conclusions: The data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject ITST devices will perform in a substantially equivalent manner to the predicate devices.
Clinical Performance and Conclusions:
Clinical trial data and conclusions were not needed for these devices to show substantial equivalence.