Closed Supracondylar Fractures
Severely Comminuted Supracondylar Fractures with Articular Involvement
Nonunions or Pseudoarthroses
Malunions
Pathological Fractures
Fractures without Extensive Comminution
Distal Fractures Involving Osteoporotic Bone
Fractures Involving the Femoral Condyles that Require Open Knee Access
T-Condylar Fractures
– Femoral Shaft Fracture with Attendant Femoral Neck Fractures (Nail to be Used in Conjunction with Fixation Screws or Plates as Needed)
Intertrochanteric Femoral Shaft Fractures
Ipsilateral Femorotibial Fractures ("Floating Knee" Fractures)
Femoral Shaft Fractures
Bilateral Femoral Shaft Fractures
Ipsilateral Patellofemoral Fractures

The tibial nail is indicated for use in a variety of tibial fractures, such as:

Comminuted Fractures
Segmental Fractures
Fractures with Bone Loss
Proximal and Distal Fractures
Nonunions
Transverse Fractures
Oblique Fractures
Spiral Fractures
Bilateral Fractures
Fractures with Butterfly Fragments
Pseudarthrosis of the Tibial Shaft
Corrective Osteotomies

The humeral nail is indicated for use in a variety of humeral fractures, such as:

Comminuted Fractures
Segmental Fractures
Fractures with Bone Loss
Proximal and Distal Fractures
— Nonunions
Delayed Unions
Pathological Fractures
Floating Elbow
– Nerve Lesion
Multiple Trauma Injuries

Device Description

This submission covers line extensions and labeling changes to the Zimmer M/DN Intramedullary Fixation System. The Zimmer M/DN Intramedullary Fixation System is used for closed nailing of femoral, tibial, and humeral shaft fractures and includes femoral nails, retrograde femoral nails, tibial nails, humeral nails, self-tapping interlocking screws, nail caps, and cortical nuts. The nails are cannulated stainless steel rods with proximal and distal holes for insertion of interlocking screws.

AI/ML Overview

This document is a 510(k) premarket notification for the Zimmer M/DN Intramedullary Fixation System. It does not describe an AI medical device or a study proving its performance against acceptance criteria. Instead, it is a regulatory submission for a physical medical device (intramedullary fixation rods) and focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI device. The document explicitly states: "Clinical data and conclusions were not needed for these devices to show substantial equivalence."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.

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

June 15, 2015

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

Re: K142281

Trade/Device Name: Zimmer M/DN Intramedullary Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: August 25, 2014 Received: August 26, 2014

Dear Mr. McKelvey:

This letter corrects our substantially equivalent letter of October 22, 2014.

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

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(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 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

Lori A. Wiggins -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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142281

Device Name

Zimmer M/DN Intramedullary Fixation System

Indications for Use (Describe)

The femoral nail is indicated for use in a variety of femoral fractures, such as:

Subtrochanteric Fractures
Intertrochanteric Fractures
Comminuted Fractures
Segmental Fractures
Fractures with Bone Loss
Proximal and Distal Fractures
Nonunions

The retrograde femoral nail is indicated for use in a variety of retrograde type femoral fractures, such as:

Closed Supracondylar Fractures
Severely Comminuted Supracondylar Fractures with Articular Involvement
Nonunions or Pseudoarthroses
Malunions
Pathological Fractures
Fractures without Extensive Comminution
Distal Fractures Involving Osteoporotic Bone
Fractures Involving the Femoral Condyles that Require Open Knee Access
T-Condylar Fractures

– Femoral Shaft Fracture with Attendant Femoral Neck Fractures (Nail to be Used in Conjunction with Fixation Screws or Plates as Needed)

Intertrochanteric Femoral Shaft Fractures
Ipsilateral Femorotibial Fractures ("Floating Knee" Fractures)
Femoral Shaft Fractures
Bilateral Femoral Shaft Fractures
Ipsilateral Patellofemoral Fractures

The tibial nail is indicated for use in a variety of tibial fractures, such as:

Comminuted Fractures
Segmental Fractures
Fractures with Bone Loss
Proximal and Distal Fractures
Nonunions
Transverse Fractures
Oblique Fractures
Spiral Fractures
Bilateral Fractures
Fractures with Butterfly Fragments
Pseudarthrosis of the Tibial Shaft
Corrective Osteotomies

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The humeral nail is indicated for use in a variety of humeral fractures, such as: - Comminuted Fractures - Segmental Fractures - Fractures with Bone Loss - Proximal and Distal Fractures — Nonunions - Delayed Unions - Pathological Fractures - Floating Elbow – Nerve Lesion - Multiple Trauma Injuries Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K142281 Page 1 of 4

Image /page/4/Picture/1 description: The image contains the logo for Zimmer Biomet. The logo features a blue letter Z inside of a blue circle. Below the circle is the name "zimmer" in lowercase blue letters.

510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Stephen H. McKelveySenior Project Manager, Trauma Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 372-4605
Date:	May 4, 2015
Trade Name:	Zimmer® M/DN® Intramedullary Fixation System
Common Name:	Intramedullary Rod
Classification Name/Reference:	Rod, Intramedullary Fixation (21 CFR 888.3020, HSB)
Classification Panel:	Orthopedics/87
Predicate Device(s):	Supracondylar Intramedullary Nail (Zimmer, K962561,cleared September 25, 1996), Intramedullary Nail System(Zimmer, K965098, cleared February 28, 1997), ZimmerNatural Nail System Retrograde Femoral Nails (Zimmer,K101622, cleared October 1, 2010)
Purpose and DeviceDescription:	This submission covers line extensions and labelingchanges to the Zimmer M/DN Intramedullary FixationSystem. The Zimmer M/DN Intramedullary FixationSystem is used for closed nailing of femoral, tibial, andhumeral shaft fractures and includes femoral nails,retrograde femoral nails, tibial nails, humeral nails, self-tapping interlocking screws, nail caps, and cortical nuts.The nails are cannulated stainless steel rods with proximaland distal holes for insertion of interlocking screws.
Intended Use:	The femoral nail is indicated for use in a variety offemoral fractures, such as:- Subtrochanteric Fractures- Intertrochanteric Fractures- Comminuted Fractures- Segmental Fractures

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Fractures with Bone Loss l
| Proximal and Distal Fractures
-Nonunions

The retrograde femoral nail is indicated for use in a variety of retrograde type femoral fractures, such as:

Closed Supracondylar Fractures
Severely Comminuted Supracondylar Fractures with l Articular Involvement
Nonunions or Pseudoarthroses —
Malunions —
Pathological Fractures -
-Fractures without Extensive Comminution
Distal Fractures Involving Osteoporotic Bone —
Fractures Involving the Femoral Condyles that Require Open Knee Access
-T-Condylar Fractures
। Femoral Shaft Fracture with Attendant Femoral Neck Fractures (Nail to be Used in Conjunction with Fixation Screws or Plates as Needed)
-Intertrochanteric Femoral Shaft Fractures
Ipsilateral Femorotibial Fractures ("Floating Knee" --Fractures)
Femoral Shaft Fractures -
Bilateral Femoral Shaft Fractures —
-Ipsilateral Patellofemoral Fractures

The tibial nail is indicated for use in a variety of tibial fractures, such as:

Comminuted Fractures
Segmental Fractures --
-Fractures with Bone Loss
Proximal and Distal Fractures -
-Nonunions
-Transverse Fractures
Oblique Fractures —
Spiral Fractures -
-Bilateral Fractures
Fractures with Butterfly Fragments
Pseudarthrosis of the Tibial Shaft —
-Corrective Osteotomies

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	The humeral nail is indicated for use in a variety ofhumeral fractures, such as:- Comminuted Fractures- Segmental Fractures- Fractures with Bone Loss- Proximal and Distal Fractures- Nonunions- Delayed Unions- Pathological Fractures- Floating Elbow- Nerve Lesion- Multiple Trauma Injuries
Comparison to Predicate Device:	The Zimmer M/DN Intramedullary Fixation System nails,screws, cortical nut, and locking cap covered by thissubmission are similar in intended use, design, materials,and performance characteristics to the predicate devices.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:Shelf Life - Accelerated aging testing conductedshows that the sterile nails and screws included in thissubmission have a shelf life of 10 years. For thecortical nut and locking cap, real time testing showsthat these specific devices have a shelf life of 5 years. Biocompatibility – Biocompatibility testing on thenail and screw material was conducted per ISO 109931 and Good Laboratory Practices (21 CFR 58). Alltesting passed

Comparison to Predicate Device:

The Zimmer M/DN Intramedullary Fixation System nails,screws, cortical nut, and locking cap covered by thissubmission are similar in intended use, design, materials,and performance characteristics to the predicate devices.

Performance Data (Nonclinicaland/or Clinical):

Non-Clinical Performance and Conclusions:Shelf Life - Accelerated aging testing conductedshows that the sterile nails and screws included in thissubmission have a shelf life of 10 years. For thecortical nut and locking cap, real time testing showsthat these specific devices have a shelf life of 5 years. Biocompatibility – Biocompatibility testing on thenail and screw material was conducted per ISO 109931 and Good Laboratory Practices (21 CFR 58). Alltesting passed

Performance Evaluation Engineering analyses • were conducted for the Retrograde Femoral Nail line extensions and for the 5.5mm Cortical Nut and Nail Locking Cap to show that these devices were equivalent in strength to their respective predicate devices.
The results demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.

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Conclusions: The data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject devices will perform in a substantially equivalent manner to the predicate devices.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for these devices to show substantial equivalence.

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.