(114 days)
No
The description focuses on the mechanical properties and materials of a temporary fracture fixation device, with no mention of AI or ML capabilities.
No
The device is described as a system for "temporary fracture fixation and stabilization of the bone," which is a treatment for injuries rather than a device for "diagnosing, treating, or preventing disease."
No
This device is a surgical implant (intramedullary nail system) used for temporary fracture fixation and stabilization, not for diagnosing medical conditions.
No
The device description clearly describes physical hardware components (intramedullary nails, screws, nail caps, washers, nuts) made of Ti-6Al-4V alloy and UHMWPE, intended for surgical implantation. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary fracture fixation and stabilization of the bone." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an "intramedullary nail" made of metal, designed to be inserted into the femur. This is a physical implant.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing samples.
The information provided clearly describes a surgical implant used for orthopedic purposes, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Indications for use of the retrograde femoral nails in the femur include:
- Compound and simple shaft fractures .
- Proximal, metaphyseal, and distal shaft fractures .
- Segmental fractures .
- . Closed supracondylar fractures
- Severely comminuted supracondylar fractures with articular involvement .
- . Fractures involving femoral condyles
- Comminuted fractures .
- Fractures involving osteopenic and osteoporotic bone .
- . Pathological fractures
- Fractures with bone loss .
- Pseudoarthrosis, non-union, and mal-union .
- . Periprosthetic fractures
- Poly trauma patients .
Product codes
HSB
Device Description
The Zimmer Natural Nail System Retrograde Femoral Nails are a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. They are inserted into the femur in a retrograde mode and are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps, cortical washers and cortical nuts are available for use with the system. All components are manufactured from Ti-6Al-4V alloy. The cortical nut also contains UHMWPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur
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
Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing included: Proximal Nail Fatigue Test, Distal Nail Fatigue Test, Midshaft Nail Analysis, Nail Torsional Stiffness Analysis, Screw Bending Fatigue Test, Screw Insertion Load Test, Screw Insertion Torque Test, Screw Torque to Failure Test, and Shelf Life Testing of UHMWPE.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle is the word "zimmer" in a smaller, sans-serif font.
K101622 lg2
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
510(k) Summary
TT 1 2011
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name and Reference:
Predicate Devices:
Device Description:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
Daniel J. Williman, RAC Specialist, Regulatory Affairs Telephone: (574) 371-8065 Fax: (574) 372-4605
September 1, 2010
Zimmer® Natural Nail™ System Retrograde Femoral Nails
Intramedullary Fixation Rod
Intramedullary fixation rod, product code HSB 21 CFR § 888.3020
Supracondylar Intramedullary Nail, manufactured by Zimmer, Inc. (K962561, cleared September 25, 1996)
DePuy ACE Universal and Troch Entry Femoral Nail Systems, manufactured by DePuy ACE (K033329, cleared November 14, 2003)
The Zimmer Natural Nail System Retrograde Femoral Nails are a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. They are inserted into the femur in a retrograde mode and are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps, cortical washers and cortical nuts are available for use with the system. All components are
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K101622 Pg 2g2
manufactured from Ti-6Al-4V alloy. The cortical nut also contains UHMWPE.
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Indications for use of the retrograde femoral nails in the femur include:
- . Compound and simple shaft fractures
- Proximal, metaphyseal, and distal shaft fractures
- Segmental fractures
- Closed supracondylar fractures ●
- Severely comminuted supracondylar fractures ● with articular involvement
- . Fractures involving femoral condyles
- Comminuted fractures �
- Fractures involving osteopenic and osteoporotic ● bone
- . Pathological fractures
- . Fractures with bone loss
- . Pseudoarthrosis, non-union, and mal-union
- Periprosthetic fractures
- . Poly trauma patients
The Zimmer Natural Nail system is similar or identical in intended use, materials, sterility, and performance characteristics to the predicate device(s).
Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing included: Proximal Nail Fatigue Test, Distal Nail Fatigue Test, Midshaft Nail Analysis, Nail Torsional Stiffness Analysis, Screw Bending Fatigue Test, Screw Insertion Load Test, Screw Insertion Torque Test, Screw Torque to Failure Test, and Shelf Life Testing of UHMWPE.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Intended Use:
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer Inc. % Mr. Daniel J. Williman, RAC Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581
OCT 4 2010
Re: K101622
Trade/Device Name: Zimmer® Natural Nail™ System Retrograde Femoral Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 30, 2010 Received: October 1, 2010
Dear Mr. Williman:
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.
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. Daniel J. Williman, RAC
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/Resourcesfor You/Industry/default.htm.
Sincerely yours
For Doth Dih
Nir
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized "Z" inside, followed by the word "zimmer" in a bold, sans-serif font. The "Z" in the circle is black, and the word "zimmer" is also black.
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer® Natural Nail™ System Retrograde Femoral Nail
Indications for Use:
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Indications for use of the retrograde femoral nails in the femur include:
- Compound and simple shaft fractures .
- Proximal, metaphyseal, and distal shaft fractures .
- Segmental fractures .
- . Closed supracondylar fractures
- Severely comminuted supracondylar fractures with articular involvement .
- . Fractures involving femoral condyles
- Comminuted fractures .
- Fractures involving osteopenic and osteoporotic bone .
- . Pathological fractures
- Fractures with bone loss .
- Pseudoarthrosis, non-union, and mal-union .
- . Periprosthetic fractures
- Poly trauma patients .
Prescription Use X (Part 21 CFR 801 Subpart D)
XM
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sigr Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101622
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