The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Cephalomedullary nails 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

Device Description

The Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short are 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. These devices are made from Ti-6Al-4V alloy and are provided sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short. This document focuses on demonstrating that the modified device is substantially equivalent to existing predicate devices, rather than on proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information cannot be directly extracted from this document, as it outlines a different type of regulatory submission.

However, I can extract information regarding the performance data used to support the substantial equivalence claim.

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: The document does not explicitly state numerical "acceptance criteria" in the way a clinical trial would (e.g., target specificity or sensitivity values). Instead, the implicit acceptance criterion is that the modifications "would not affect safety and effectiveness" when compared to the predicate devices.
Reported Device Performance:
- Fatigue strength evaluation: Performed on the proximal segment of the subject nail.
- Distal tip evaluation: Assessment of tensile stress under cantilever loading.
- Conclusion: "The results of non-clinical (lab) performance testing demonstrate that the subject devices are safe and effective and substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance:

Sample Size: This is not specified for the non-clinical testing. It would typically be a engineering test sample size, not human subjects.
Data Provenance: "Non-clinical (lab) performance testing." This implies in-vitro or bench testing, not data from human subjects or clinical settings.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. For non-clinical (lab) performance testing of mechanical properties, "ground truth" is established through engineering and material science principles and measurements, not expert clinician consensus.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable. As this involves direct mechanical testing, there is no need for adjudication as typically seen in clinical image interpretation or diagnosis.

5. 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:

No. This document describes the regulatory approval of a hardware medical device (intramedullary nail), not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Engineering/Material Science Standards: The "ground truth" for the non-clinical tests would be established by industry standards, engineering specifications, and validated measurement techniques for fatigue strength and tensile stress.

8. The sample size for the training set:

Not Applicable. There is no "training set" in the context of this type of non-clinical mechanical performance testing.

9. How the ground truth for the training set was established:

Not Applicable.

Summary Table of Available Information:

Criterion/Information	Details from Document
Acceptance Criteria	Implicit: Modifications "would not affect safety and effectiveness" compared to predicate devices.
Reported Device Performance (against Implicit Criteria)	Fatigue strength evaluation: Proximal segment of the nail. Distal tip evaluation: Tensile stress under cantilever loading. Conclusion: Results demonstrate devices are safe, effective, and substantially equivalent to predicate devices.
Sample Size (Test Set)	Not specified (non-clinical lab testing).
Data Provenance (Test Set)	Non-clinical (lab) performance testing.
Number of Experts for Ground Truth (Test Set)	Not applicable (engineering/material science focus).
Qualifications of Experts	Not applicable.
Adjudication Method	Not applicable.
MRMC Comparative Effectiveness Study	No. (Device is hardware, not AI diagnostic).
Standalone Performance (Algorithm-only)	No. (Device is hardware).
Type of Ground Truth Used	Engineering/Material Science Standards and measurements (for fatigue strength and tensile stress), not clinical ground truth like pathology or expert consensus from human subjects.
Sample Size (Training Set)	Not applicable. (No "training set" for this type of mechanical testing as it's not a machine learning model).
How Ground Truth for Training Set was Established	Not applicable.

This document is primarily concerned with showing substantial equivalence to existing devices through engineering tests, rather than a clinical trial with human subjects and diagnostic performance metrics.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" inside of a circle, with the word "zimmer" written in lowercase letters below the circle. The letter "Z" is black, and the circle is a thin black line. The word "zimmer" is also black.

Sponsor:

Contact Person:

Date:

Trade Name:

Common Name:

Classification Names And References:

Predicate Devices:

Device Description:

Intended Use:

2 P.O. Box 708

Warsaw. IN 46581-0708 574 267-6131

510(k) Summary

AUG 1 0 2012

Zimmer, GmbH SulzerAllee 8 Winterthur, Switzerland CH-8404

Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs Telephone: (574) 372-4944 Fax: (574) 371-8760

August 9, 2012

Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short

Intramedullary Fixation Rod

Intramedullary Fixation Rod , product code HSB (21 CFR section 888.3020)

Zimmer Natural Nail System Cephalomedullary Femoral Nails, Manufactured by Zimmer, K091566, cleared October 28, 2009 and Intramedullary Nail System, Manufactured by Zimmer, K965098, cleared February 28, 1997.

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.

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K120 715 PAGE 2 OF 2 Indications for use of the Cephalomedullary nails 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 Comparison to Predicate Device: The subject Zimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short have three modifications when compared to the predicate Zimmer Natural Nail System Cephalomedullary Femoral Nails; 1) A 9.3 mm diameter line extension was added to the nail scope, 2) the tip design of the subject nails was changed by moving the distal locking holes 20 mm distally and reducing the length of the tip slots/flutes, and 3) the distal locking hole angle was changed from 8.5 degrees to 7.0 degrees to accommodate a minor change in the associated targeting guide instrument. All other design and processing parameters (e.g., other dimensions, materials, sterilization, packaging, etc.) are identical to the predicate devices. Performance Data (Nonclinical Non-Clinical Performance and Conclusions: And/or Clinical): Testing/Analysis performed included; A fatigue strength evaluation of the proximal segment of the subject nail and a distal tip evaluation of the tensile stress under cantilever loading to confirm that the modifications would not affect safety and effectiveness. The results of non-clinical (lab) performance testing demonstrate that the subject devices are safe and effective and substantially equivalent to the predicate devices. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

AUG 1 0 2012

Zimmer. GmbH. % Mr. Stephen H. McKelvey, MA, RAC Zimmer. Inc. 345 East Main St. Warsaw. IN 46580

Re: K120715

Trade/Device Name: Zimmer Natural Nail System - Cephalomedullary Femoral Nail - Asia Short

Regulation Number: 21 CFR 888.3020 Regulation Name: Rod, fixation, intramedullary and accessories Regulatory Class: II Product Code: HSB Dated: July 10, 2012 Received: July 12, 2012

Dear Mr. McKelvey:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Stephen H. McKelvey

forth in the quality systems (OS) 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,

Erind Keith

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:

ீ cimmer Natural Nail System Cephalomedullary Femoral Nail - Asia Short

Indications for Use:

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.

Indications for use of the Cephalomedullary nails 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 needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ashf

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

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.