The Apex Tibial Nailing system is intended for temporary fixation of the fractures of the tibia. The Apex nail is indicated for used in adult patients for treatment of:

· Open and closed tibial fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures;
· Fractures involving osteopenic or osteoporotic bone;
· Fractures with bone loss;
Pseudoarthosis, nonunion, and malunion;
· Correction osteotomy;
· Pathologic fractures and prophylactic nailing of impending pathologic fractures; and
· Reconstruction following tumour resection.

Device Description

The Apex Tibial Nailing System is a tibial intramedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws by means of a provided reusable surgical instrumentation kit. Like many of the currently-marketed intramedullary nails, the Apex Nail offers several different proximal and distal locking options from which the surgeon may choose, depending on the fracture. An insert within the proximal nail stem maintains the torsional stability of static locking when the construct is locked in a dynamization mode. The Apex Tibial Nailing System includes a tibial nail, bone screws and endcaps of varying sizes. All parts of the system are manufactured from Titanium 6AL4VELi. The Apex Tibial Nail, screw and endcap are available in varying lengths and diameters.

AI/ML Overview

This document describes the regulatory approval for a medical device called the "Apex Tibial Nailing System." It is a 510(k) premarket notification, which means the device is being compared to existing, legally marketed predicate devices to demonstrate substantial equivalence. Therefore, the information provided focuses on comparative data and adherence to established standards rather than a clinical study establishing new performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Compliance)
ASTM F1264-16 - Standard specification and test methods for intramedullary fixation devices	All acceptance criteria were met.
ASTM F543-07 – Standard specification and test methods for metallic medical bone screws	All acceptance criteria were met.
Full construct fatigue testing	All acceptance criteria were met.

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the "acceptance criteria" are typically defined by recognized consensus standards (like ASTM standards) that apply to the device type. The reported performance is the assertion that the device successfully passed these standardized tests and met all specified requirements within those standards.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the "sample size used for the test set" in terms of number of devices or clinical cases. The testing described is non-clinical performance testing (mechanical and material testing, per ASTM standards). Therefore, the data provenance is from laboratory testing rather than patient data, and it is retrospective in the sense that the testing was conducted on manufactured devices before this submission.

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

This information is not applicable to this document. The "ground truth" for the non-clinical performance testing is established by the specifications and methodologies outlined in the ASTM standards themselves, rather than through expert consensus on clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable. Since the testing is non-clinical and objective (e.g., strength, fatigue, material composition), an adjudication method for a "test set" in the sense of clinical data interpretation is not relevant.

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 done. This submission is for a medical implant and relies on non-clinical performance testing and substantial equivalence to predicate devices, not on AI assistance to human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an AI or software algorithm.

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" is defined by the specifications and requirements within the referenced ASTM standards (ASTM F1264-16 and ASTM F543-07), as well as the parameters for "Full construct fatigue testing." These standards define acceptable material properties, mechanical strength, and fatigue resistance for intramedullary fixation devices and bone screws.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device, as it is a mechanical implant and not an AI or machine learning model that requires training data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

Summary

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December 20, 2017 OrthoXel % Hollace Rhodes Director, Orthopedic Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001

Re: K170972

Trade/Device Name: Apex Tibial Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, HWC Dated: November 20, 2017 Received: November 20, 2017

Dear Hollace Rhodes:

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 of medical device-related adverse events) (21 CFR 803); good

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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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Vincent J. Devlin -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

510(k) Number (if known)

K170972

Device Name Apex Tibial Nailing System

The Apex Tibial Nailing system is intended for temporary fixation of the fractures of the tibia. The Apex nail is indicated for used in adult patients for treatment of:

· Open and closed tibial fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures;
· Fractures involving osteopenic or osteoporotic bone;
· Fractures with bone loss;
Pseudoarthosis, nonunion, and malunion;
· Correction osteotomy;
· Pathologic fractures and prophylactic nailing of impending pathologic fractures; and
· Reconstruction following tumour resection.

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)

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510(k) Summary for Apex Tibial Nailing System

1.1 Submission Sponsor

OrthoXel, Rubicon Centre, Bishopstown, Cork, Ireland, T12 Y275 Phone: +353 21 2429700

Contact: Aisling O'Sullivan QA/RA Manager Email: aisling.osullivan@orthoxel.ie

1.2 Prepared by
Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street, NW, Suite 1000 Washington, DC 20001 Phone: 202.552.5800

Contact: Ms. Hollace Saas Rhodes Director, Orthopedic Regulatory Affairs Email: hrhodes@mcra.com

1.3 Date Prepared
18 December 2017

1.4 Device Name

1.4.1	Trade/Proprietary Name:	Apex Tibial Nailing System
1.4.2	Common/Usual Name:	Tibial Nail
1.4.3	Classification Name:	Intramedullary Fixation Rod
1.4.4	Classification Regulation:	21 CFR 888.3020
1.4.5	Classification Panel:	Orthopedics
1.4.6	Product Codes:	HSB, HWC
	1.4.7	=

1.5 Predicate Devices

The System is substantially equivalent to the Biomet Tibial Locking Nail System (K063570), the Zimmer Natural Nail (K082770), and L.T.S. IM Nail Systems CFN-CHN (K132945) based on similarities in intended use, technological characteristics, and performance data.

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1.6 Device Description

1.7 Intended Use

The Apex Tibial Nailing System is intended for temporary fixation of the fractures of the tibia. The Apex nail is indicated for used in adult patients for treatment of:

. Open and closed tibial fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures;
. Fractures involving osteopenic or osteoporotic bone;
Fractures with bone loss;
Pseudoarthrosis, nonunion, and malunion;
Correction osteotomy;
Pathologic fractures and prophylactic nailing of impending pathologic fractures; and
Reconstruction following tumour resection.

1.8 Technological Characteristics and Substantial Equivalence

The Apex Tibial Nailing System is substantially equivalent to the Biomet Tibial Locking Nail System, the Zimmer Natural Nail, and the L.T.S. IM Nail Systems CFN-CTN-CHN with respect to intended use, technological characteristics (components, materials, overall design, and dimensions), sterility, and principles of operation.

1.9 Non-Clinical Performance Testing

The Apex Tibial Nailing System was tested in accordance with the following standards and all acceptance criteria were met:

. ASTM F1264-16 - Standard specification and test methods for intramedullary fixation devices.
ASTM F543-07 – Standard specification and test methods for metallic medical bone screws.
- Full construct fatigue testing

Conclusion 1.10

This 510(k) submission supports the substantial equivalence of the Apex Tibial Nailing System to the referenced predicate devices.

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.