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 .

When this device is implanted using a Suprapatella surgical approach, all of the above indications apply with the exception of Periprosthetic Fractures.

Device Description

The ZNN Tibial Nail System is a cannulated, intramedullary rod intended to restore the shape of the injured tibia to its pre-injured state. The nail implants are available in a variety of lengths and diameters to meet assorted anatomical needs and come in both Ti-6Al-4V alloy and 22-13-5 stainless steel to address surgeon preference. Minor modifications have been made to some of the instrumentation associated with the ZNN Tibial Nail System and to the surgical technique to allow implantation through an incision above the natural patella.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device can be implanted safely using the modified technique.	"All design verification activities confirmed that the ZNN Tibial Nails can be implanted using the modified suprapatellar surgical technique and instruments and that they provide a safe and repeatable approach similar to the surgical technique currently used for the predicate ZNN Tibial Nail System."
Effectiveness: Device effectively restores the shape of the injured tibia and provides temporary fracture fixation/stabilization using the modified technique.	"The final implanted location of the ZNN Tibial Nail implant is the same as with the currently cleared surgical techniques.""The ZNN Tibial Nails can be implanted using the suprapatella technique and instruments and provide a safe and effective approach similar to the surgical technique currently used."
Risk Mitigation: Identified risks are properly mitigated.	"The design verification activities concluded that all risks identified were properly mitigated."
Substantial Equivalence: The modified system is substantially equivalent to the predicate device.	"Comparisons of the design, indications, and design control activities confirmed that the modified ZNN Tibial Nail System is substantially equivalent to the predicate ZNN Tibial Nail System."
Indications for Use: The modified system can be used for the same indications as the predicate (with one exception for the suprapatella approach).	"The indications for use of the modified system and the original system remain the same." (Referencing the listed indications in the document). The exception: "When this device is implanted using a Suprapatella surgical approach, all of the above indications apply with the exception of Periprosthetic Fractures."
Fundamental Scientific Technology: The modification does not change the fundamental scientific technology.	"The addition of an optional suprapatella technique and the associated instrumentation does not change the fundamental scientific technology of the ZNN Tibial Nail System."

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."

Therefore, there was no "test set" in the traditional sense of a clinical study involving patients. The performance data relied on "design verification activities." The document does not provide details on the sample size or provenance of data used for these design verification activities (e.g., number of tests, materials tested, etc.).

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

Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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

No MRMC comparative effectiveness study was mentioned or performed. The submission is for a modification to an existing device, and clinical data was deemed unnecessary.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is a physical medical device (intramedullary fixation rod), not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the device's performance relies on engineering design verification and validation activities rather than clinical outcomes or expert consensus on patient data. This includes evaluations of the instruments and the surgical technique to ensure they perform as intended and safely.

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device and not an AI algorithm requiring a training set.

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

Not applicable, as there was no training set for an AI algorithm. The performance of the modified device was established through non-clinical design verification activities to demonstrate substantial equivalence to the predicate device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a stylized letter Z inside of a circle. Below the circle is the word "zimmer" in a sans-serif font.

K130595

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

510(k) Summary

Sponsor:

Zimmer, Inc. P.O. Box 708 Warsaw. IN 46581-0708 EP 1 7 2013

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

Date:

Trade Name:

Contact Person:

March 5, 2013 ·

System Modification - ZNN System Tibial Nail and Stainless Steel Tibial Nail

Common Name: Intramedullary Fixation Rod

Classification Names and References:

Classification Panel:

Predicate Devices:

Purpose:

Device Description:

Rod, Fixation, Intramedullary and Accessories (21 CFR 888.3020, Product Code HSB)

· Orthopedics/87

Zimmer Natural Nail (ZNN) System Tibial Nail (K082770, cleared December 11, 2008), Zimmer Natural Nail System Stainless Steel Tibial Nail (K090596, cleared June 30, 2009)

This Special 510(k) is being submitted to add eight instruments to support an optional surgical technique (suprapatella approach) for the ZNN System Tibial Nail and ZNN System Stainless Steel Tibial Nail.

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K130595

Intended 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 .

When this device is implanted using a Suprapatella surgical approach, all of the above indications apply with the exception of Periprosthetic Fractures.

The modified ZNN Tibial Nail System is identical to the predicate ZNN Tibial Nail System except that a suprapatella approach and modified instruments have been added which allow the ZNN Tibial Nail to be implanted through an incision above the natural patella as opposed to inserting the nail through an incision on the shelf of the tibia through or adjacent to the patellar ligament.

Non-Clinical Performance and Conclusions:

The addition of an optional suprapatella technique and the associated instrumentation does not change the fundamental scientific technology of the ZNN Tibial Nail System. The indications for use of the modified system and the original system remain the same.

All design verification activities confirmed that the ZNN Tibial Nails can be implanted using the modified suprapatellar surgical technique and instruments and that they provide a safe and repeatable approach similar to the surgical technique currently used for the predicate ZNN Tibial Nail System. The final implanted location of the ZNN Tibial Nail implant is the same as with the currently cleared surgical techniques. The design verification activities concluded that all risks identified were properly mitigated.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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K130595

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

Summary

Comparisons of the design, indications, and design control activities confirmed that the modified ZNN Tibial Nail System is substantially equivalent to the predicate ZNN Tibial Nail System. The ZNN Tibial Nails can be implanted using the suprapatella technique and instruments and provide a safe and effective approach similar to the surgical technique currently used.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three wavy lines extending from its body.

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

September 17, 2013

Zimmer Incorporated Mr. Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs Zimmer Incorporated P.O. Box 708 Warsaw, Indiana 46581

Re: K130595

Trade/Device Name: System Modification - ZNN System Tibial Nail and Stainless Steel Tibial Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: August 9, 2013 Received: August 14, 2013

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

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Page 2 - Mr. Stephen McKelvey

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Laurence D. Coyne -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130595

Device Name:

System Modification - ZNN System Tibial Nail and Stainless Steel Tibial Nail

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 .

When this device is implanted using a Suprapatella surgical approach, all of the above indications apply with the exception of Periprosthetic 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)

Casey L. Hanley Ph.D.
Division of Orthopedic Devices

Page 1 of 1

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.