(117 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a physical implant (intramedullary nail system) for fracture fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for "temporary fracture fixation and stabilization of the bone," which involves treating or alleviating a medical condition.
No
The device description clearly states it is a "temporary fixation intramedullary nail designed for fracture fixation and stabilization of the bone," which is a treatment, not a diagnostic, function.
No
The device description explicitly states that the Zimmer Natural Nail System consists of "temporary fixation intramedullary nails" and associated hardware components made from stainless steel. This indicates a physical medical device, not a software-only one.
Based on the provided information, the Zimmer Natural Nail System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "temporary fracture fixation and stabilization of the bone." This is a surgical intervention performed directly on the patient's body.
- Device Description: The device is described as "temporary fixation intramedullary nails" and associated components like screws and caps, all made of stainless steel. These are physical implants used to stabilize bone fractures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens.
Therefore, the Zimmer Natural Nail System is a surgical implant, not an IVD.
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 the Tibial nails include the following in the tibia:
- 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
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 (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Zimmer Natural Nail System Stainless Steel Tibial Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the tibia. The Zimmer Natural Nail System Stainless Steel Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. All 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 made from stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, tibia, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance 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 (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.
K082770, K083497, K965098, K043270, K033329
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.
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K090596 Page 1 of 3
Summary of Safety and Effectiveness
JUN 30 2009
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 Associate, Regulatory Affairs Telephone: (574) 371-8065 Fax: (574) 372-4605
March 4, 2009
Zimmer® Natural Nail™ System Stainless Steel Tibial Nail & Stainless Steel Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails
Intramedullary Fixation Rod
Intramedullary fixation rod, product code HSB 21 CFR § 888.3020
Zimmer® Natural Nail™ System Tibial Nail, manufactured by Zimmer, Inc. (K082770, cleared December 11, 2008)
Zimmer Natural Nail System Piriformis Fossa & Greater Trochanter Antegrade Femoral Nails, manufactured by Zimmer, Inc. (K083497, cleared February 19, 2009)
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 ACE. (K033329, cleared November 14, 2003)
The Zimmer Natural Nail System Stainless Steel Tibial Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization
013
1
Kogo596 page 2 of 3
of the tibia. The Zimmer Natural Nail System Stainless Steel Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. All 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 made from stainless steel.
The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Indications for the Tibial nails include the following in the tibia:
- · 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
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
Intended Use:
2
K090596 Page 3 of 3
- · Pseudoarthrosis, non-union, mal-union and delayed union
- · Periprosthetic fractures
- · Surgically created defects such as osteotomies
- · Intertrochanteric and subtrochanteric fractures
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
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.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUN 3 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer, Inc. c/o Mr. Daniel J. Williman Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K090596
Trade/Device Name: Zimmer Natural Nail system Stainless Steel Tibial Nail & Stainless Steel Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: June 24, 2009 Received: June 25, 2009
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 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's requirements, including, but not limited to: registration and listing (21
4
Page 2 - Mr. Daniel J. Williman
CFR Part 807); labeling (21 CFR Part 801); 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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Barbau Burns
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K090596
Device Name:
Zimmer® Natural Nail™ System Stainless Steel Tibial Nails & Stainless Steel 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 the Tibial nails include the following in the tibia:
- 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
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
| 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 if necded)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) |
Page 1 of 1
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K090596
012