(86 days)
Not Found
No
The device description and intended use are focused on a mechanical intramedullary nail system for fracture fixation, with no mention of AI or ML capabilities.
Yes.
The device is intended for fracture fixation and stabilization of bone, which are therapeutic interventions.
No
Explanation: The device description states that the Zimmer Natural Nail System is intended for "temporary fracture fixation and stabilization of the bone," which is a treatment, not a diagnostic function.
No
The device description clearly states it is a system of intramedullary nails and associated hardware (screws, nail caps) made of Ti-6Al-4V alloy, which are physical components, not software.
Based on the provided information, 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," specifically in the femur. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an "intramedullary nail system" made of Ti-6Al-4V alloy, designed to be implanted within the bone.
- 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 outside the body.
The Zimmer Natural Nail System is a surgical implant used for orthopedic procedures, not an in vitro diagnostic device.
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 Greater Trochanter and Piriformis Fossa Antegrade Femoral nails in the femur include:
- · Compound and simple shaft fractures
- · Proximal, metaphyseal and distal shaft fractures
- · Segmental fractures
- · Comminuted fractures
- · Fractures involving osteopenic and osteoporotic bone
- · Pathological fractures
- · Fractures with bone loss
- · Pseudoarthrosis, non-union, mal-union and delayed union
- · Periprosthetic fractures
- · Surgically created defects such as osteotomies
- · Intertrochanteric and subtrochanteric fractures
Product codes
HSB
Device Description
The Zimmer Natural Nail System Antegrade Femoral Nails are a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails 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 are available to prevent tissue ingrowth into nail threads and increase the length of the nail if desired. All components are available in Ti-6Al-4V alloy.
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 testing demonstrate that the devices are safe and effective.
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.
0
K083497 (pg. 1 of 2)
Image /page/0/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The logo is black and white.
Traditional 510(k) Premarket Notification
Summary of Safety and Effectiveness
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
FEB 1 9 2009
Daniel J. Williman Associate, Regulatory Affairs Telephone: (574) 371-8065 Fax: (574) 372-4605
November 24, 2008
Zimmer® Natural Nail™ System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails
Intramedullary Fixation Rod
Intramedullary fixation rod, product code HSB 21 CFR § 888.3020
Intramedullary Nail System, manufactured by Zimmer, Inc. (K965098, cleared February 28, 1997)
Sirus® Nail System, manufactured by Zimmer, GmbH. (K043270, cleared January 31, 2005)
DePuy ACE Universal and Troch Entry Femoral Nail Systems, manufactured by DePuy Orthopaedics (K033329, cleared November 14, 2003)
The Zimmer Natural Nail System Antegrade Femoral Nails are a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails 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 are available to prevent tissue ingrowth into nail
1
K083497 (pg. 2 of 2.)
Image /page/1/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in lowercase letters. The font is bold and sans-serif, and the color is black.
Intended Use:
Traditional 510(k) Premarket Notification
threads and increase the length of the nail if desired. All components are available in Ti-6Al-4V alloy.
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Indications for use of the Greater Trochanter and Piriformis Fossa Antegrade Femoral nails in the femur include:
- · Compound and simple shaft fractures
- · Proximal, metaphyseal and distal shaft fractures
- · Segmental fractures
- · Comminuted fractures
- · Fractures involving osteopenic and osteoporotic bone
- · Pathological fractures
- · Fractures with bone loss
- · Pseudoarthrosis, non-union, mal-union and delayed union
- · Periprosthetic fractures
- · Surgically created defects such as osteotomies
- · Intertrochanteric and subtrochanteric fractures
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 testing demonstrate that the devices are safe and effective.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The eagle is stylized and composed of multiple lines, giving it a modern and dynamic appearance. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2009
Zimmer, Inc. C/o Mr. Daniel J. Williman Regulatory Affairs Associate P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K083497
Trade 12 1 Trochanter Antegrade Femoral Nails
Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: November 24, 2008 Received: November 25, 2008
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 tice-Ari include requirements:for-stunis@viegastcations/3sting.off devices, good manufacturing practice, labeling, and probibitions 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 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 srequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Mr. Daniel J. Williman
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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact .CDRH's . Office .of .Surveillance and Biometrics" . (OSB.'s) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 M. Mather
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): 长083497
Device Name:
Zimmer® Natural Nail™ System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails
Indications for Use:
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Indications for use of the Greater Trochanter and Piriformis Fossa nails in the femur include:
.
*** .
- · Compound and simple shaft fractures
- · Proximal, metaphyseal and distal shaft fractures
- · Segmental fractures
- · Comminuted fractures
- · Fractures involving osteopenic and osteoporotic bone
- · Pathological fractures
- · Fractures with bone loss
- · Pseudoarthrosis, non-union, mal-union and delayed union
- · Periprosthetic fractures
- · Surgically created defects such as osteotomies
- · Intertrochanteric and subtrochanteric fractures
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
- 19.4
(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 Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K683497 |
|---|---|
| --------------- | --------- |
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