The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for 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 Nails are temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. They restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. A set screw (with a polyethylene peg) allows guided rotational stability of the lag screw. Nails, nail caps and screws are made from Tivanium Ti-6Al-4V Alloy. Set screws are made from Tivanium Ti-6Al-4V Alloy and Polyethylene (PE). Selected components of the Zimmer Natural Nail System are color coded to aid in identifying which components should be used together. The package label for each of the nails indicates which screw sizes should be used with that nail. A screw case that holds unused screws intended for resterilization is available and contains designated sections for each screw size. Each section contains the color name that matches the color/color name on the label of the appropriate screw size for that section. Refer to the color coding chart and/or surgical technique for more detailed instructions on the use of Zimmer Natural Nail System components.

AI/ML Overview

The provided document, K192312, is a 510(k) premarket notification for a medical device: the Zimmer Natural Nail System Cephalomedullary Nails. It details the substantial equivalence of the device to existing predicate devices.

Based on the provided text, there is no information about an AI/algorithm-driven device or its performance criteria. The document exclusively discusses an intramedullary fixation rod for fracture fixation and stabilization of the bone.

Therefore, I cannot provide details on:

A table of acceptance criteria and reported device performance for an AI/algorithm.
Sample sizes for test sets or data provenance for an AI/algorithm.
Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
Adjudication methods for an AI/algorithm's test set.
Multi-reader multi-case (MRMC) comparative effectiveness studies for an AI/algorithm.
Standalone AI/algorithm performance.
Type of ground truth used for AI/algorithm.
Sample size for training set or how ground truth was established for an AI/algorithm and its training set.

The document explicitly states under "Performance Data (Nonclinical and/or Clinical)":

"Non-Clinical Performance and Conclusions: Class II: Amendment of Design Controls with verification of mechanical integrity and resistance."
"Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

This indicates that the clearance was based on mechanical integrity testing and design control amendments, not on a clinical performance study involving AI or human interpretation of images.

Summary

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October 11, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zimmer GmbH Danielle Madureira Senior Specialist, Regulatory Affairs Sulzerallee 8 CH-8404 Winterthur Switzerland

Re: K192312

Trade/Device Name: Zimmer Natural Nail System Cephalomedullary Nails Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: August 21, 2019 Received: August 26, 2019

Dear Danielle Madureira:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Stereotaxic. Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192312

Device Name

ZIMMER® NATURAL NAIL® SYSTEM CEPHALOMEDULLARY NAIL

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

|X | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The color of the text is a dark gray.

K192312

510(k) Summary

Sponsor:	Zimmer GmbHSulzerallee 8, P.O. Box8404 Winterthur, Switzerland
Contact Person:	Danielle Jannuzzi MadureiraSenior Specialist, Regulatory AffairsTelephone: +41 58 854 82 60Fax: +41 52 244 86 58
Date:	October 21, 2019
Trade Name:	ZIMMER® NATURAL NAIL® SYSTEM CEPHALOMEDULLARY NAIL
Classification Product Code :	HSB - Intramedullary Fixation Rod
Device Classification Name:	Rod, fixation, intramedullary and accessories
Regulation Number / Description:	21 CFR § 888.3020 Intramedullary fixation rod
Predicate Device:	Zimmer Natural Nail System Cephalomedullary Nails, manufacturedby Zimmer GmbH, K091566, cleared October 2009 and its lineextension Zimmer Natural Nail System Cephalomedullary FemoralNails - Asia Short, manufactured by Zimmer GmbH, K120715,cleared October 2012
Device Description:	The Zimmer® Natural Nail® System Cephalomedullary Nails aretemporary fixation intramedullary nails designed for fracture fixationand stabilization of the femur. They restore the shape of preinjuredbone and are available in a variety of lengths and diameters to meetassorted anatomical needs. Nail caps are available to protect the nailthreads from tissue ingrowth and extend the nail length if necessary.Each of the intramedullary nails is secured by a series of screws thatpass through holes in the nail. A set screw (with a polyethylene peg)allows guided rotational stability of the lag screw. Nails, nail caps andscrews are made from Tivanium Ti-6Al-4V Alloy. Set screws are madefrom Tivanium Ti-6Al-4V Alloy and Polyethylene (PE).Selected components of the Zimmer Natural Nail System are colorcoded to aid in identifying which components should be usedtogether. The package label for each of the nails indicates whichscrew sizes should be used with that nail. A screw case that holdsunused screws intended for resterilization is available and containsdesignated sections for each screw size. Each section contains thecolor name that matches the color/color name on the label of theappropriate screw size for that section. Refer to the color coding chartand/or surgical technique for more detailed instructions on the use ofZimmer Natural Nail System components.
Intended Use:	The Zimmer Natural Nail System is intended for temporary fracturefixation and stabilization of the bone.Indications for 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 intended use of the modified devices, as described in its labeling,has not changed as a result of the modifications proposed in thepresent submission. Zimmer GmbH is seeking clearance for certainsystem specific Class II instruments - these instruments that havepreviously considered Class I exempt and correction of classificationto Class II is proposed within present submission.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:Class II: Amendment of Design Controls with verification ofmechanical integrity and resistance.Clinical Performance and Conclusions:Clinical data and conclusions were not needed for this device.
Conclusion:	The subject devices have the same intended use and similarindications for use as the predicate devices. The subject devices usethe same operating principle, incorporate the same basic design andlabeling and are manufactured and sterilized using the same materialsand processes as the predicate devices.Except for the modifications described in this submission the subjectdevices are identical to the predicate devices, and the performancedata and analyses demonstrate that:• any differences do not raise new questions of safety andeffectiveness as established with performance testing; and

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Image /page/4/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a gray sans-serif font. The logo is simple and modern, with a focus on the company name.

the subject devices are at least as safe and effective as the • legally marketed predicate devices.

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.