The XtraFix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (femur, tibia, foot and humerus) and pelvic fractures that require external fixation. Specifically, the system is intended for:
-Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;
-Arthrodesis and osteotomies with associated soft tissue problems;
-Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;
-Stabilization of non-unions; and
-Intraoperative temporary stabilization tool to assist with indirect reduction.

Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;
Arthrodesis and osteotomies with associated soft tissue problems;
Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;
Stabilization of non-unions; and
Intraoperative temporary stabilization tool to assist with indirect reduction.

Device Description

A Bar to Pin, 2D, independent locking clamp and a half pin are being added to the XtraFix Large System. A Bar/Pin to Bar/Pin, 2D, independent locking clamp and carbon fiber bars are being added to the XtraFix Small System. The XtraFix Large and Small Systems include the following elements: clamps, bars and half pins. The XtraFix Large and Small Systems are designed in such a way that several different types of frames can be assembled. Pins are inserted into bone, and then clamps are assembled to the pins. Bars are assembled to the clamps and a frame is constructed. After reducing the fracture, all clamps are tightened to hold the frame in place.

AI/ML Overview

This document is a 510(k) summary for the Zimmer XtraFix External Fixation System and XtraFix Small External Fixation System. It focuses on demonstrating substantial equivalence to predicate devices and establishing MRI conditional status for specific components, rather than providing a study on the effectiveness of a diagnostic or AI-based device. Therefore, a direct answer to the acceptance criteria and study proving device meets acceptance criteria in the requested format for AI/diagnostic devices is not applicable.

However, I can extract information related to the performance testing and acceptance criteria as provided for this external fixation system in the context of its regulatory clearance.

Acceptance Criteria for the XtraFix External Fixation System (Non-Clinical Performance)

The relevant "acceptance criteria" and "device performance" in this context are derived from non-clinical performance data, primarily demonstrating mechanical and MRI-compatibility characteristics.

Acceptance Criteria Category	Specific Acceptance Criteria (Method/Standard)	Reported Device Performance
Mechanical Performance (Line Additions)	Substantially Equivalent to predicate devices based on ASTM F1541-02 (2011) e1 Standard Specification and Test Methods for External Fixation Devices and FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices.	Static axial & torsional grip strength testing and rigidity analyses confirmed that the line additions (new clamps and half pin for Large System, new clamps and carbon fiber bars for Small System) are substantially equivalent to the predicate devices.
MRI Conditional Status (XtraFix Large System w/ Carbon Fiber Bars - 3T MRI)	Magnetic Force: Force generated for device components in 3T MRI is less than the force on respective components due to gravity.	Force generated for device components in a 3T MRI is lesser than the force on the respective components due to gravity.
	Torque: Device components do not experience a measurable torque in a 3T static field.	The device components do not experience a measurable torque in a 3T static field.
	Heating (64 MHz): With worst-case construct 50cm from center of magnet, heating at most 4.5 °C (15 mins, scaled to 2.0 W/kg whole body SAR).	Heating was at most 4.5 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
	Heating (128 MHz): With worst-case construct 50cm from center of magnet, heating at most 2.3 °C (15 mins, scaled to 2.0 W/kg whole body SAR).	heating was at most 2.3 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
	Image Artifact: Largest image artifact did not extend more than 60mm from the device.	Largest image artifact did not extend more than 60mm from the device.
MRI Conditional Status (XtraFix Small System w/ Carbon Fiber Bars - 3T MRI)	Magnetic Force: Force generated for device components in 3T MRI is less than the force on respective components due to gravity.	Force generated for the device components in a 3T MRI is lesser than the force on the respective components due to gravity.
	Torque: Device components do not experience a measurable torque in a 3T static field.	The device components do not experience a measurable torque in a 3T static field.
	Heating (64 MHz): With worst-case construct 50cm from center of scanner bore, heating at most 1.3 °C (15 mins, scaled to 2.0 W/kg whole body SAR).	Heating was at most 1.3 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
	Heating (128 MHz): With worst-case construct 50cm from center of scanner bore, heating at most 3 °C (15 mins, scaled to 2.0 W/kg whole body SAR).	Heating was at most 3 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
	Image Artifact: Largest image artifact did not extend more than 63mm from the device.	Largest image artifact did not extend more than 63mm from the device.

Information Relevant to Study Details (within the context of this 510(k) submission):

This document describes a 510(k) submission for line additions and MRI conditional claims for an existing medical device, not a diagnostic or AI study. Therefore, many of the requested details for AI/diagnostic studies are not applicable.

Sample size used for the test set and the data provenance:
- Mechanical Testing: Not specified as a "sample size" in terms of patient data. It refers to "line additions" (new device components) that underwent testing. The context implies mechanical testing was performed on representative units of these new components.
- MRI Testing: The tests were conducted on "worst-case constructs" of the XtraFix Large System and XtraFix Small System with carbon fiber bars. The sample size for these physical tests would likely be a small number of physical prototypes or manufactured units rather than patient data.
- Data Provenance: The tests are non-clinical, performed in a laboratory setting (implied). No country of origin for patient data is relevant.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and MRI conditional testing is established by engineering standards and physical measurements, not expert consensus on medical images or pathology.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving human interpretation or adjudication.
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 is a medical device for fracture fixation, not an AI or diagnostic imaging device.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical Testing: Ground truth is based on engineering specifications, physical properties, and comparative performance against predicate devices as defined by standards like ASTM F1541-02 (2011) e1.
- MRI Testing: Ground truth is based on physical measurements of magnetic force, torque, temperature change, and image artifact size as per FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment."
The sample size for the training set: Not applicable. This is not a machine learning or AI-based device.
How the ground truth for the training set was established: Not applicable. There is no training set for this type of device submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and support.

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

September 18, 2014

Zimmer, Incorporated Romil Sheth Specialist, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K141697

Trade/Device Name: Xtrafix® External Fixation System, Xtrafix® Small External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDW Dated: June 23, 2014 Received: June 24, 2014

Dear Romil Sheth:

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

{1}------------------------------------------------

(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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K141697 (pg 1/2)

Device Name

XtraFix® External Fixation System

Indications for Use (Describe)

-Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;

-Arthrodesis and osteotomies with associated soft tissue problems;

-Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;

-Stabilization of non-unions; and

-Intraoperative temporary stabilization tool to assist with indirect reduction.

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."

{3}------------------------------------------------

Indications for Use

510(k) Number (if known)

K141697 (pg 2/2)

Device Name

XtraFix® Small External Fixation System

Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated;
Arthrodesis and osteotomies with associated soft tissue problems;
Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;
Stabilization of non-unions; and
Intraoperative temporary stabilization tool to assist with indirect reduction.

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.

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."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a large, stylized blue letter "Z" enclosed in a blue circle. Below the symbol, the word "zimmer" is written in lowercase, using a modern, sans-serif font, also in blue.

510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Romil ShethSpecialist, Trauma Regulatory Affairs, Zimmer, Inc.Telephone: 574-371-1621Fax: 574-371-8760
Date SummaryPrepared:	06/18/2014
Trade Name:	1) XtraFix® External Fixation System (also referred to as XtraFixLarge System)2) XtraFix® Small External Fixation System (also referred to asXtraFix Small System)
Common Name:	External Fixation Frame Components
Classification Nameand Reference:	XtraFix Large System21 CFR 888.3030 - Single/multiple component metallic bonefixation appliances and accessories21 CFR 888.3040 - Smooth or threaded metallic bone fixationfastener
	XtraFix Small System21 CFR 888.3030 - Single/multiple component metallic bonefixation appliances and accessories
Product Code:	XtraFix Large SystemKTT and JDW
	XtraFix Small SystemKTT
Classification Panel:	Orthopedic/87

{5}------------------------------------------------

Predicate Device(s):	XtraFix Large System-XtraFix External Fixation System, Zimmer, K113383 cleared on06/26/2012XtraFix Small System-XtraFix Small External Fixation System, Zimmer, K131413 clearedon 01/28/2014-TransFx External Fixation System, Zimmer, K990848 cleared on5/17/1999
Purpose andDevice Description:	The purpose of this traditional 510(k) is to seek clearance to marketthe line additions to the XtraFix Large and Small Systems. Thistraditional 510(k) also covers the proposed change to add a MRIconditional symbol on the existing carbon fiber bars in the XtraFixLarge System so that the XtraFix Large System constructs withcarbon fiber bars can be used in the MR environment (entirelyoutside the bore of the MRI scanner).A Bar to Pin, 2D, independent locking clamp and a half pin are beingadded to the XtraFix Large System. A Bar/Pin to Bar/Pin, 2D,independent locking clamp and carbon fiber bars are being added tothe XtraFix Small System. The XtraFix Large and Small Systemsinclude the following elements: clamps, bars and half pins. TheXtraFix Large and Small Systems are designed in such a way thatseveral different types of frames can be assembled. Pins are insertedinto bone, and then clamps are assembled to the pins. Bars areassembled to the clamps and a frame is constructed. After reducingthe fracture, all clamps are tightened to hold the frame in place.
Intended Use:	XtraFix Large SystemThe XtraFix External Fixation System is indicated for use inconstruction of an external fixation frame for treatment of longbone (femur, tibia, foot and humerus) and pelvic fractures thatrequire external fixation. Specifically, the system is intended for:-Stabilization of open or closed fractures, typically in the contextof polytrauma or where open or alternative closed treatment isundesirable or otherwise contraindicated:

Predicate Device(s):

XtraFix Large System-XtraFix External Fixation System, Zimmer, K113383 cleared on06/26/2012XtraFix Small System-XtraFix Small External Fixation System, Zimmer, K131413 clearedon 01/28/2014-TransFx External Fixation System, Zimmer, K990848 cleared on5/17/1999

Purpose andDevice Description:

The purpose of this traditional 510(k) is to seek clearance to marketthe line additions to the XtraFix Large and Small Systems. Thistraditional 510(k) also covers the proposed change to add a MRIconditional symbol on the existing carbon fiber bars in the XtraFixLarge System so that the XtraFix Large System constructs withcarbon fiber bars can be used in the MR environment (entirelyoutside the bore of the MRI scanner).A Bar to Pin, 2D, independent locking clamp and a half pin are beingadded to the XtraFix Large System. A Bar/Pin to Bar/Pin, 2D,independent locking clamp and carbon fiber bars are being added tothe XtraFix Small System. The XtraFix Large and Small Systemsinclude the following elements: clamps, bars and half pins. TheXtraFix Large and Small Systems are designed in such a way thatseveral different types of frames can be assembled. Pins are insertedinto bone, and then clamps are assembled to the pins. Bars areassembled to the clamps and a frame is constructed. After reducingthe fracture, all clamps are tightened to hold the frame in place.

Intended Use:

XtraFix Large SystemThe XtraFix External Fixation System is indicated for use inconstruction of an external fixation frame for treatment of longbone (femur, tibia, foot and humerus) and pelvic fractures thatrequire external fixation. Specifically, the system is intended for:-Stabilization of open or closed fractures, typically in the contextof polytrauma or where open or alternative closed treatment isundesirable or otherwise contraindicated:

-Arthrodesis and osteotomies with associated soft tissue problems; -Stabilization of limbs after removal of total joint arthroplasty for infection or other failure;

-Stabilization of non-unions; and

{6}------------------------------------------------

-Intraoperative temporary stabilization tool to assist with indirect reduction.

XtraFix Small System

The XtraFix Small External Fixation System is indicated for use in construction of an external fixation frame for treatment of appropriately sized long bone (foot, arm, wrist and hand) fractures that require external fixation. Specifically, the system is intended for: Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated; Arthrodesis and osteotomies with associated soft tissue problems; --Stabilization of limbs after removal of total joint arthroplasty for infection or other failure; -Stabilization of non-unions; and -Intraoperative temporary stabilization tool to assist with indirect reduction.

Summary of Technological Characteristics: The independent locking clamps being added to the XtraFix Large and Small Systems are intended to hold half pins and bars. These clamps allow for both their jaws to independently tighten upon the element (half pin/bar) they have grasped by tightening the respective nut. The half pin being added to the XtraFix Large System has a 6mm shank/major thread diameter; its overall length is 250mm and it has an 85mm long threaded portion. This half pin is made from 316L stainless steel (per ASTM F138). The bars being added to the XtraFix Small System are 6mm in diameter and have lengths ranging from 65mm to 300mm. These bars are made from carbon fiber/epoxy composite material. Performance Data (Nonclinical and/or The line additions to the XtraFix Large and Small Systems have been Clinical): characterized and evaluated according to the requirements outlined in ASTM F1541-02 (2011) e1 Standard Specification and Test Methods for External Fixation Devices and FDA Reviewers Guidance Checklist for Orthopedic External Fixation Devices. Static axial & torsional grip strength testing and the rigidity analyses confirmed that the line additions to the XtraFix Large and Small Systems are substantially equivalent to the predicate devices.

{7}------------------------------------------------

In addition. the XtraFix Large System with carbon fiber bars was found to be MRI Conditional per the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on August 21, 2008. The MRI conditional claim is supported by the following,

Force generated for the device components in a 3T MRI is lesser than the force on the respective components due to gravity;
The device components do not experience a measurable torque in a 3T static field:
With the worst-case construct placed 50cm away from the center of the magnet of a MR scanner (64 MHz) the heating was at most 4.5 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg
With the worst-case construct placed 50cm away from the center of the magnet of a MR scanner (128 MHz) the heating was at most 2.3 °C following 15 minutes of exposure when scaled to a whole body SAR level of 2.0 W/kg.
Largest image artifact did not extend more than 60mm from the device.

Also, the XtraFix Small System with carbon fiber bars was found to be MRI Conditional per the FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" issued on August 21, 2008. The MRI conditional claim is supported by the following,

Force generated for the device components in a 3T MRI is lesser than the force on the respective components due to gravity;
The device components do not experience a measurable torque in a 3T static field:
With the worst-case construct placed 50cm away from the center of the MR scanner (64 MHz) bore the heating was at most 1.3 ℃ following 15 minutes of exposure when scaled to a whole body SAR

level of 2.0 W/kg.

With the worst-case construct placed 50cm away from the center of the MR scanner (128 MHz) bore the heating was at most 3 °C following 15 minutes of exposure when scaled to a whole body SAR

level of 2.0 W/kg. 5) Largest image artifact did not extend more than 63mm from the device.

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

{8}------------------------------------------------

Substantial Equivalence Information:

The line additions to the XtraFix Large and Small Systems have same/similar indications for use, have same/similar design features, come in same/similar sizes, are made from same/similar material, and are provided non-sterile like their predicate devices. Further, performance testing and engineering rationales included in this submission demonstrate that any differences in technological characteristics do not adversely affect the safety and effectiveness of the line additions to the XtraFix Large and Small System.

Also, the indications for use, size, shape, materials and sterility of the existing carbon fiber bars in the XtraFix Large System to which we are proposing to add a MRI conditional symbol remain unchanged. Further, the MRI related testing and engineering rationales included in this submission demonstrate that using the carbon fiber bars in the MR environment (entirely outside the bore of MRI scanner) do not adversely affect the safety of the XtraFix Large System.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.