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.

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.

AI/ML Overview

This document refers to a 510(k) premarket notification for the Zimmer® Natural Nail™ System Retrograde Femoral Nail. The device is an intramedullary fixation rod. The 510(k) summary explicitly states that clinical data and conclusions were not needed for this device (Page 1, "Clinical Performance and Conclusions"). This means the device approval did not rely on studies demonstrating its performance against acceptance criteria in a clinical setting.

Instead, the approval was based on non-clinical (lab) performance testing demonstrating that the devices are safe, effective, and substantially equivalent to predicate devices. The listed tests are mechanical in nature, assessing the physical properties and durability of the nail and screws.

Given this, I cannot provide the detailed information requested in your prompt as the study described in the document is a non-clinical, mechanical testing study, not a clinical study involving human subjects or AI performance.

Therefore, the following information is not applicable or extractable from the provided document:

A table of acceptance criteria and the reported device performance (for clinical performance): Not applicable, as no clinical performance study was conducted. The document lists mechanical performance tests (e.g., fatigue, torsional stiffness, insertion load) but does not provide specific acceptance criteria or quantitative results for these tests.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical test set was used. For the non-clinical tests, sample sizes for mechanical testing are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical ground truth was established.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device for fracture fixation, not an AI or imaging diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of available information regarding performance:

Acceptance Criteria (Mechanical Testing): Not explicitly stated in terms of quantitative values. The general criterion is that the device "demonstrates that the devices are safe and effective and substantially equivalent to the predicate devices."
Reported Device Performance (Mechanical Testing): The document states "The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices." Specific quantitative results are not provided in this 510(k) summary.
Study Type: Non-clinical (lab) performance testing, focusing on mechanical properties, not clinical efficacy or diagnostic accuracy.
Tests Performed: 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.

Summary

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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)

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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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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)

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

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.