Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Open and closed fracture fixation
Pseudarthrosis of long bones
Limb lengthening by distraction
Correction of bony or soft tissue deformities
Infected fractures
Nonunions

Smith & Nephew Taylor Spatial Frame Fixator:

Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Open and closed fracture fixation
Pseudarthrosis of long bones
Limb lengthening by distraction
Correction of bony or soft tissue deformities
Joint arthrodesis
Infected fractures
Nonunions

Smith & Nephew JET-X Fixator:

Open and closed fractures fixation
Bony or soft tissue deformities
Infected fractures
Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius

Smith & Nephew Ilizarov System:

Fractures and disease which generally may result in ioint contractures or loss of range of motion and fractures requiring distraction
Open and closed fracture fixation
Pseudarthrosis of long bones
Limb lengthening by distraction (not applicable for use with COMPASS Universal Hinge)
Correction of bony or soft tissue deformities (not applicable for use with COMPASS Universal Hinge)
Joint arthrodesis (not applicable for use with COMPASS Universal Hinge)
Infected fractures
Nonunions

Device Description

The Smith & Nephew External Fixation Systems consist of the TAYLOR SPATIAL FRAME Fixator, ILIZAROV External Fixator, JET-X Fixator and the Smith & Nephew Rail System. In general, each system consists of a unique combination of pins, bars, clamps, rings, struts, rods and/or rails to achieve fixation of a bone or joint. The JET-X system can be used with various clamps, pins, and carbon fiber bars to provide versatility in achieving fixation. The JET-X MINI system utilizes a smaller subset of components from the JET-X system. The MRS consists of a combination of pins, modular rail segments (linear or arcs), clamps, and distraction/compression device(s) to provide fixation. The TSF assemblies generally utilize 2-3 rings (half ring, 2/3 ring, full ring, and/or foot ring) or plates (U-plate), as well as struts to provide the framework for fixation. A series of rods, pins, and wires are then used to provide stability and fixation to the bone. The ILIZAROV system generally implements thin wire fixation alone or as an adjunct to internal fixation. Like the TSF, the ILIZAROV system contains a frame that consists of a combination of rings and rods, while pins and wires provide fixation of the frame to the bone.

AI/ML Overview

This document is a 510(k) premarket notification for Smith & Nephew's Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, and Other External Fixation systems. The primary purpose of this submission is to add MR safety information to the labeling and update indications for use and package inserts due to European MDR related changes.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Test Standard)	Device Performance
Magnetically induced displacement force (ASTM F2052)	Supports appropriate MR parameters and symbols found in labeling (Implies adherence to safety limits)
Magnetically induced torque (ASTM F2213)	Supports appropriate MR parameters and symbols found in labeling (Implies adherence to safety limits)
Radiofrequency (RF) induced heating (ASTM F2182)	Supports appropriate MR parameters and symbols found in labeling (Implies adherence to safety limits)
MR image artifact (ASTM F2119)	Supports appropriate MR parameters and symbols found in labeling (Implies adherence to safety limits)

2. Sample size used for the test set and the data provenance:

The document states that "MRI compatibility testing/assessment was conducted." However, it does not specify the sample size for the test set (number of devices tested for MRI compatibility). The data provenance is not explicitly mentioned in terms of country of origin, but the testing was conducted to FDA guidance, suggesting a U.S. regulatory context. It is a prospective assessment of the device's MR safety characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. For MRI compatibility testing, ground truth is typically established by comparing test results against established safety limits and standards (e.g., maximum temperature increase, allowable displacement). This typically involves engineering and physics experts rather than medical experts for ground truth establishment.

4. Adjudication method for the test set:

This information is not provided. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of data, which is not directly applicable to a performance study for MRI compatibility of an external fixator. The assessment relies on meeting predefined technical standards.

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:

This is not applicable to this submission. This submission is for physical devices (external fixators) and their MRI compatibility, not for an AI-powered diagnostic or assistive tool.

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

This is not applicable to this submission as it concerns physical medical devices, not algorithms or AI.

7. The type of ground truth used:

The ground truth used for this study is based on established scientific and regulatory standards for MRI compatibility. Specifically, the document references:

FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment," December 11, 2014.
International standards: ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119.

These standards define the acceptable limits for various magnetic resonance interactions (displacement, torque, heating, artifact) for medical implants.

8. The sample size for the training set:

This is not applicable. This submission is for the physical performance testing of medical devices, not for a machine learning or AI model that requires a training set. The devices being cleared are substantially equivalent to existing predicate devices, with the primary new information being MR safety data.

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

This is not applicable as there is no training set for an AI model mentioned in this submission.

Summary

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December 8, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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" in blue, with the word "ADMINISTRATION" in a smaller font size below it.

Smith & Nephew, Inc. Brad Sheals Senior Regulatory Affairs Manager 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K201253

Trade/Device Name: Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, LXT, JDW, OSN Dated: November 6, 2020 Received: November 10, 2020

Dear Brad Sheals:

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

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

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 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 (OS) 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 Ting Song. PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure List of cleared devices in K201253

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List of Cleared Devices in K201253

Smith & Nephew Rail System – MR Unsafe
Taylor Spatial Frame External Fixator – MR Conditional (only when used with Frame Stabilizer Tool)

1. JET-X Fixator MR Conditional
1. ILIZAROV External Fixator MR Unsafe

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510(k) Number (if known)

Device Name ILIZAROV SYSTEM

Indications for Use (Describe)

Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Open and closed fracture fixation
Pseudarthrosis of long bones
Limb lengthening by distraction (not applicable for use with COMPASS Universal Hinge)
Correction of bony or soft tissue deformities (not applicable for use with COMPASS Universal Hinge)
Joint arthrodesis (not applicable for use with COMPASS Universal Hinge)
Infected fractures
Nonunions

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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510(k) Number (if known)

Device Name JET-X System

Indications for Use (Describe)

Open and closed fractures fixation
Bony or soft tissue deformities
Infected fractures
Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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510(k) Number (if known)

Device Name MODULAR RAIL SYSTEM

Indications for Use (Describe)

Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction

1. Open and closed fracture fixation
1. Pseudarthrosis of long bones
1. Limb lengthening by distraction
1. Correction of bony or soft tissue deformities
1. Infected fractures
1. Nonunions

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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510(k) Number (if known)

Device Name TAYLOR SPATIAL FRAME

Indications for Use (Describe)

Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction

1. Open and closed fracture fixation
1. Pseudarthrosis of long bones
1. Limb lengthening by distraction
1. Correction of bony or soft tissue deformities
1. Joint arthrodesis
1. Infected fractures
1. Nonunions

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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K201253 Page 1 of 5 h&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Contact Person:	Mr. Brad Sheals, MSSenior Regulatory Affairs ManagerT 901-288-7141
Date Prepared:	November 19, 2020
Name of Device:	Smith & Nephew Modular Rail System, Smith &Nephew Taylor Spatial Frame Fixator, Smith &Nephew JET-X Fixator, Smith & Nephew OtherExternal Fixation, Ilizarov External FixationSystem
Common Name:	External Fixators and Accessories
Device Classification Nameand Reference:	21 CFR 888.3030 Single/multiple componentmetallic bone fixation appliances and accessories.
	21 CFR 888.3040 Smooth or threaded metallicbone fixation fastener
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	KTT, LXT, JDW, OSN
Predicate Device:	Smith & Nephew Modular Rail System, Smith &Nephew Taylor Spatial Frame Fixator, Smith &Nephew JET-X Fixator, Smith & Nephew OtherExternal Fixation, Ilizarov External Fixation System

The predicate devices have not been subject to a design-related recall.

No reference devices were used in this submission.

Device Description

The primary purpose of this Traditional 510(k) is to add the MR safety information to the labeling for the Smith & Nephew External Fixations Systems. In addition, select product systems within the submission are modifying the indications for use and updating the package insert due to European MDR related updates. The Smith & Nephew External Fixation Systems consist of the TAYLOR SPATIAL FRAME Fixator, ILIZAROV External Fixator, JET-X Fixator and the Smith & Nephew Rail System. In general, each system consists of a unique combination of pins, bars, clamps, rings, struts, rods and/or rails to achieve fixation of a bone or joint. The JET-X system can be used with various clamps, pins, and carbon fiber bars to provide versatility in achieving fixation. The JET-X MINI system utilizes a smaller subset of components from the JET-X system. The MRS

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consists of a combination of pins, modular rail segments (linear or arcs), clamps, and distraction/compression device(s) to provide fixation. The TSF assemblies generally utilize 2-3 rings (half ring, 2/3 ring, full ring, and/or foot ring) or plates (U-plate), as well as struts to provide the framework for fixation. A series of rods, pins, and wires are then used to provide stability and fixation to the bone. The ILIZAROV system generally implements thin wire fixation alone or as an adjunct to internal fixation. Like the TSF, the ILIZAROV system contains a frame that consists of a combination of rings and rods, while pins and wires provide fixation of the frame to the bone. As seen in the subject device submission, the device design, technological characteristics, physical properties (e.q. materials), function of the devices, manufacturing processes, packaging and sterilization remain unchanged.

Indications for Use

The indications for the Smith & Nephew External Fixation Systems are the following:

Smith&Nephew Modular Rail System

Indication for Use

1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
1. Open and closed fracture fixation
1. Pseudarthrosis of long bones
1. Limb lengthening by distraction
1. Correction of bony or soft tissue deformities
1. Infected fractures
1. Nonunions

Smith & Nephew Taylor Spatial Frame Fixator Indication for Use

1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
1. Open and closed fracture fixation
1. Pseudarthrosis of long bones
1. Limb lengthening by distraction
1. Correction of bony or soft tissue deformities
1. Joint arthrodesis
1. Infected fractures
1. Nonunions

Smith & Nephew JET-X Fixator Indication for Use

1. Open and closed fractures fixation
1. Bony or soft tissue deformities
1. Infected fractures
1. Mini external fixator systems are indicated for the management of comminuted intra-articular fractures of the distal radius

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Smith & Nephew Ilizarov System Indication for Use

1. Fractures and disease which generally may result in ioint contractures or loss of range of motion and fractures requiring distraction
1. Open and closed fracture fixation
1. Pseudarthrosis of long bones
1. Limb lengthening by distraction (not applicable for use with COMPASS Universal Hinge)
1. Correction of bony or soft tissue deformities (not applicable for use with COMPASS Universal Hinge)
1. Joint arthrodesis (not applicable for use with COMPASS Universal Hinge)
1. Infected fractures
1. Nonunions

Technological Characteristics

There are no technology differences between the subject device and predicate devices as these devices are intended for use as external fixators. The device design and material of the subject device are same as the predicate Smith & Nephew System(s) cleared under the premarket notifications listed in Tables 5.1-5.5.

Performance Data

The following performance data was provided in support of the substantial equivalence determination.

Magnetic resonance Imaging (MRI)

MRI compatibility testing/assessment was conducted as per the FDA's quidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014 and the standards listed below:

1. Magnetically induced displacement force (ASTM F2052)
1. Magnetically induced torque (ASTM F2213)
1. Radiofrequency (RF) induced heating (ASTM F2182)
1. MR image artifact (ASTM F2119)

In summary, MR safety testing/assessment supports the appropriate MR parameters and symbols found in the subject device labeling.

{10}------------------------------------------------

Substantial Equivalence Information

The subject Smith & Nephew External Fixation Systems are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to the commercially available predicate devices listed in their respective tables below.

Table 5.1: Substantially Equivalent Predicates to the External Fixation Systems
---------------------------------------------------------------------------------	--

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,	Smith & Nephew Rail	K090926	6/8/2009
Inc.	System	K120871	6/7/2012

Table 5.2: Substantially Equivalent Predicates to the External Fixation Systems

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	TAYLOR SPATIAL FRAMEExternal Fixator	K023921	2/5/2003
		K994143	2/18/2000
		K093047	9/27/2010

Table 5.3: Substantially Equivalent Predicates to the External Fixation Systems

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	JET-X Fixator	K023134	10/9/2002
		K072212	3/7/2008
		K994143	2/18/2000
		K042312	9/24/2004
		K120871	6/7/2012

Table 5.4: Substantially Equivalent Predicates to the External Fixation Systems

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	ILIZAROV ExternalFixator/System	K042436	10/7/2004
		K920024	1/27/1992
		K953397	10/31/1995
		K970751	4/16/1997
		K994143	2/18/2000
		K970713	4/3/1997
		K093047	9/27/2010
		K120871	6/7/2012
		K130479	5/17/2013

Table 5.5: Substantially Equivalent Predicates to the External Fixation Systems

Manufacturer	Description	SubmissionNumber	Clearance Date
Smith & Nephew,Inc.	Other External Fixation	K994143 K120871	2/18/20006/7/2012

{11}------------------------------------------------

Conclusions

In summary, the only differences between the subject devices and the commercially available predicate device was supporting MR safety testing/assessment, addition of MR safety information to the labeling, the indications and the information within the package insert were updated due to European MDR related changes. These differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the subject devices. The subject Smith & Nephew External Fixation Systems are identical in function, design features, materials, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared and do not affect the safety and effectiveness of the subject devices when used as labeled. Due to the supporting documentation within this filing, it is concluded that the subject device(s) are substantially equivalent to the predicate device(s).

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.