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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zimmer® Natural Nail™ System:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety	"The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective."
Effectiveness	"The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective."
Material	"The Zimmer Natural Nail system is similar or identical in ... materials ... to the predicate device(s)."
Sterility	"The Zimmer Natural Nail system is similar or identical in ... sterility ... to the predicate device(s)."
Performance Characteristics	"The Zimmer Natural Nail system is similar or identical in ... performance characteristics to the predicate device(s)."
Intended Use	"The Zimmer Natural Nail system is similar or identical in intended use ... to the predicate device(s)."

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical data and conclusions were not needed for this device."

This indicates that:

No test set using human data was employed.
No data provenance (country of origin, retrospective/prospective) is applicable for a clinical test set.
The evaluation was based on non-clinical (lab) performance testing and comparison to predicate devices, not on a test set involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As clinical data was not used, there was no need for experts to establish ground truth for a clinical test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document indicates that clinical data and conclusions were not needed, and the evaluation was based on non-clinical testing and substantial equivalence to predicate devices. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is an intramedullary nail system, a physical surgical implant, not an algorithm or AI-based diagnostic tool. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The ground truth for the device's performance was established through:

Non-clinical (lab) performance testing: This would involve engineering and biomechanical tests to assess mechanical properties, durability, and other physical characteristics. The "ground truth" here is derived from measurable physical properties and engineering standards.
Comparison to predicate devices: The device's "ground truth" for safety and effectiveness is largely based on its similarity to previously cleared devices which have an established record of safety and effectiveness.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set was used.

Summary

{0}------------------------------------------------

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

Regulation Number and Section

§ 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.