The TRIGENTM Low Profile Bone Screw can be used with several types of nails in Smith & Nephew's (TRIGENTM) Titanium Nail System. The TRIGEN™ Low Profile Bone Screw therefore has the following indications:

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (e.g. Femoral Antegrade Nail. Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures.

In addition to the indications for intramedulary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (peri-prosthetic fractures).

The TRIGEN™ InterTAN nails are indicated for fractures of the femur including; simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures; intertrochanteric fractures; ipsilateral fractures; intracapsular fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening.

META-TANTM Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur.

In addition, META-TAN™ TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.

The TRIGENTM Low Profile Bone Screw is intended for single use only.

Device Description

The subject of this Special 510(k) Premarket Notification is the 5.0mm TRIGEN™ Low Profile Bone Screws. Specifically, subject devices are modified with a change in the tip. All described implant devices are manufactured from implant grade titanium alloy material (Ti-Al-4V) and designed for single use. The subject devices are provided in a sterile packaged option and will be sterilized via Gamma irradiation.

The subject devices are designed to be used with TRIGEN™ Titanium intramedullary nail systems.

AI/ML Overview

This document describes a Special 510(k) Premarket Notification for the Smith & Nephew TRIGEN™ Low Profile Bone Screws, which involves a modification to the screw tip.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (What was measured?)	Reported Device Performance
Insertion Torque (Comparison to original design)	The modified TRIGEN™ Low Profile Bone Screws with the design change to the screw tip require less insertion torque than the predicate. This suggests superior insertion torque performance for the modified device compared to the predicate design. No specific numerical value or range is provided for acceptance criteria or specific performance, but the comparative outcome serves as the performance indicator.
Bacterial Endotoxin Limits (Sterility assessment)	Testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance documents: "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72. No specific numerical values for endotoxin limits or actual test results are given, but compliance with established standards is reported.

Acceptance Criteria (What was measured?)

Reported Device Performance

Insertion Torque (Comparison to original design)

The modified TRIGEN™ Low Profile Bone Screws with the design change to the screw tip require less insertion torque than the predicate. This suggests superior insertion torque performance for the modified device compared to the predicate design. No specific numerical value or range is provided for acceptance criteria or specific performance, but the comparative outcome serves as the performance indicator.

Bacterial Endotoxin Limits (Sterility assessment)

Testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance documents: "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72. No specific numerical values for endotoxin limits or actual test results are given, but compliance with established standards is reported.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set (for Insertion Torque Evaluation Testing): The document does not explicitly state the sample size used for the insertion torque evaluation testing. It refers to "testing evaluated the performance of the subject device compared to the original design," but the number of devices tested is not provided.
Data Provenance: The study appears to be a prospective in-house engineering study conducted by Smith & Nephew, Inc. No country of origin is explicitly mentioned for the data, but given Smith & Nephew's location (Memphis, Tennessee) and the FDA submission, it can be inferred that the testing was conducted under appropriate U.S. regulatory and quality standards.

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

This information is not applicable to this type of submission. The studies described are primarily engineering/performance evaluations, not clinical studies requiring expert ground truth for interpretation (e.g., image analysis by radiologists). The "ground truth" for insertion torque is direct measurement, and for endotoxin testing, it's compliance with established quantitative limits.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies involving human readers/interpreters where there might be disagreement in interpretations. For mechanical testing and sterility assessments, the results are typically quantitative and objective measurements against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device submission. This type of study is relevant for diagnostic devices where human readers interpret medical images. The TRIGEN™ Low Profile Bone Screw is an orthopedic implant for fixation of fractures.

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

This concept is not applicable here as this is a physical medical device (bone screw), not an AI algorithm or software device. Performance is evaluated through mechanical testing and biological safety assessments.

7. The Type of Ground Truth Used:

For Insertion Torque Evaluation Testing: The "ground truth" is the direct measurement of insertion torque of the device itself and its comparison to the direct measurement of the predicate device.
For Bacterial Endotoxin Testing: The "ground truth" is established by quantitative limits specified in recognized international standards (e.g., ANSI/AAMI ST72) and FDA guidance documents.

8. The Sample Size for the Training Set:

This information is not applicable. This submission is for a physical medical device and its performance evaluation, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set for a physical medical device.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, forming a single abstract shape.

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

November 23, 2016

Smith & Nephew, Inc. Allison Chan Regulatory Affairs Specialist II 1450 E. Brooks Road Memphis. Tennessee 38116

Re: K161264

Trade/Device Name: TRIGEN Low Profile Bone Screws Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 27, 2016 Received: October 28, 2016

Dear Allison Chan:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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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/ResourcesforYou/Industry/default.htm. 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

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 yours,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161264

Device Name TRIGEN Low Profile Bone Screws

Indications for Use (Describe)

The TRIGENTM Low Profile Bone Screw is intended for single use only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.FORM FDA 3881 (8/14)

Page 1 of 2

PSC Publishing Services (301) 443-6740

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

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Image /page/3/Picture/0 description: The image shows the logo for Smith & Nephew. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray, and then "smith&nephew" in orange. The text is in a sans-serif font and is slightly offset to the right of the flower symbol.

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	October 27, 2016
Contact Person and Address:	Allison ChanRegulatory Affairs Specialist IIT 901-399-1098F 901-566-7022
Name of Device:	Smith & Nephew, Inc. TRIGEN™ Low ProfileBone Screws
Common Name:	Bone Screw
Device Classification Nameand Reference:	21 CFR 888.3020 Intramedullary Fixation Rod
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	HSB

Device Description

The subject devices are designed to be used with TRIGEN™ Titanium intramedullary nail systems.

Intended Use

The TRIGEN™ Low Profile Bone Screw can be used with several types of nails in Smith & Nephew's (TRIGEN™) Titanium Nail System. The TRIGEN™ Low Profile Bone Screw therefore has the following indications:

Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for

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compression and rotational stability (e.g. Femoral Antegrade Nail, Trochanteric Antegrade Nail and Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures, intertrochanteric fractures, and ipsilateral femoral shaft/neck fractures.

In addition to the indications for interlocking intramedullary nails, devices that use a retrograde femoral surgical approach (e.g. Knee Nail, Retrograde and Supracondylar Nails) are indicated for the following: comminuted supracondylar fractures with or without intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants (periprosthetic fractures).

The TRIGEN™ InterTAN nails are indicated for fractures of the femur including: simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, long oblique shaft fractures and segmental shaft fractures: subtrochanteric fractures: intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; intracapsular fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening.

META-TAN™ Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures: reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur.

In addition. META- TAN™ Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.

The TRIGEN™ Low Profile Bone Screw is intended for single use only.

Comparison to Technological Characteristics with the Predicate Device Device comparisons described in this premarket notification demonstrated that the proposed TRIGEN™ Low Profile Bone Screws are substantially equivalent to the legally marketed primary predicate devices cleared in K111025 with regard to intended use, indications for use, and performance characteristics.

The subject TRIGEN™ Low Profile Bone Screws feature characteristics as previously cleared in K111025 with the primary differences being a design change in the tip of the screw. The subject devices feature identical indications for use and intended use as the TRIGEN™ Low Profile Bone Screws offered in K111025.

Summary of Pre-Clinical Testing

Insertion Torque Evaluation Testing evaluated the performance of the . subject device compared to the original design. Test results showed the TRIGEN™ Low Profile Screws with the design change to the screw tip requires less insertion torque than the predicate. The modified TRIGEN™

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Low Profile Bone Screw would therefore be expected to have a superior insertion torque performance as compared to the predicate design.

Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance . "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.

Substantial Equivalence Information

The subject devices are identical in function, intended use, indications for use, and material composition, and very similar in overall design to the TRIGEN™ Low Profile Bone Screws cleared via premarket notification K111025.

Table 5.1 : Substantially Equivalent Predicates to the TRIGEN™ Low Profile Bone Screws

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith &Nephew	TRIGEN TM Low ProfileBone Screws	K111025	July 1, 2011

Conclusion

As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the modified TRIGEN™ Low Profile Bone Screws. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate device.

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.