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.

Device Description

The Zimmer Natural Nail System Tibial Nail is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The intramedullary nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the 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 extend the length of the nail. All components are made of TI-6AL-4V alloy material.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Zimmer® Natural Nail™ System Tibial Nail. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific statistical acceptance criteria.

Therefore, the document explicitly states: "Clinical data and conclusions were not needed for this device." This means that many of the requested elements for a study proving device performance against acceptance criteria are not applicable or available in this submission.

Here's a breakdown of the requested information based on the provided text, highlighting where information is not applicable due to the nature of a 510(k) submission:

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

Not Applicable in this 510(k) submission for clinical performance.
The device's safety and effectiveness were demonstrated through non-clinical (lab) performance testing and by showing substantial equivalence to predicate devices, not by meeting specific clinical acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable for clinical performance testing.
No human-based "test set" for clinical data was used or described. The submission is based on non-clinical (lab) testing and comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable.
Since no clinical test set was used to assess performance against a ground truth, no experts were needed for this purpose.

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

Not Applicable.
No clinical test set requiring adjudication was used.

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

Not Applicable.
This device is an intramedullary nail for fracture fixation, not an AI-assisted diagnostic tool or an imaging device. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not Applicable.
This device is a physical medical implant, not an algorithm or software-only device.

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

Not Applicable for clinical performance.
For the non-clinical lab testing, the "ground truth" would be engineering specifications and accepted standards for mechanical properties and material science.

8. The sample size for the training set

Not Applicable.
As this is not an AI/machine learning device, there is no concept of a "training set."

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

Not Applicable.
No training set was used.

Summary of Device Performance and Basis for Clearance (Extracted from the Text):

The Zimmer® Natural Nail™ System Tibial Nail was cleared based on:

Non-Clinical Performance: The results of "non-clinical (lab) performance testing demonstrate that the devices are safe and effective."
Substantial Equivalence: The device is considered "similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices."
- Predicate Devices:
  - Intramedullary Nail System, manufactured by Zimmer, Inc. (K965098, cleared February 28, 1997)
  - Sirus® Intramedullary Nail, manufactured by Zimmer, GmbH (K043270, cleared January 31, 2005)
  - DePuy Ace Versa Nail Tibial Nail, manufactured by DePuy Orthopaedics (K032097, cleared August 8, 2003)

This 510(k) submission did not require clinical performance data because it demonstrated substantial equivalence to legally marketed predicate devices through robust non-clinical testing.

Summary

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6002770 lps 1/2)

Summary of Safety and Effectiveness

DEC 11 2008

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 Specialist, Warsaw Regulatory Affairs Telephone: (574) 371-8065 Fax: (574) 372-4605

September 18, 2008

Zimmer® Natural Nail™ System Tibial Nail

Intramedullary Fixation Rod

Intramedullary fixation rod, product code HSB 21 CFR § 888.3020

Intramedullary Nail System, manufactured by Zimmer, Inc. (K965098, cleared February 28, 1997)

Sirus® Intramedullary Nail, manufactured by Zimmer, GmbH (K043270, clcared January 31, 2005)

DePuy Ace Versa Nail Tibial Nail, manufactured by DePuy Orthopaedics (K032097, cleared August 8, 2003)

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K082770 (pg 212)

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

The Zimmer Natural Nail system is similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices.

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.

Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 2008

Zimmer, Inc. % Mr. Daniel J. Williman Specialist, Warsaw Regulatory Affairs P.O. Box 708 Warsaw, IN 45681

Re: K082770

Trade/Device Name: Zimmer® Natural Nail™ System Tibial Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: September 18, 2008 Received: September 22, 2008

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 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.

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Page 2 -- Mr. Daniel J Williman

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological 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 Nai™ System 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 .

Prescription Use	X (Part 21 CFR 801 Subpart D)
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AND/OR

Over-The-Counter Use	(21 CFR 807 Subpart C)
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(Please do not write below this line - Continue on another page if needed)

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number	K082770
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032

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.