The AUTOBAHN™ Tibial Nail is indicated for stabilization of fractures in skeletally mature patients, specifically fractures of the proximal and distal tibial shaft, open and closed tibial shaft fractures, certain pre- and postisthmic fractures, non-unions, pseudarthrosis, corrective osteotomies, prophylactic nailing of impending pathological fractures, tumor resections, simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures, polytrauma and multiple fractures, reconstruction, following turnor resection and grafting, supracondylar fractures, and bone lengthening and shortening.

The AUTOBAHN™ Trochanteric Nail is indicated for treatment of fractures in adults and adolescents (12-21 years of age) in which the growth plates have for the following indications: basal neck fractures, fixation of stable and unstable intertrochanteric, and subtrochanteric fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, combinations of pertrochanteric, basal neck fractures. Iong subtrochanteric fractures, turnor resections, from trauma, nonunions, malunions, and revision procedures.

AUTOBAHN™ Antegrade/Retrograde Femoral Nails are indicated for long bone fracture fixation in skeletally mature patients, specifically femoral fracture fixation, which may include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, supracondylar fractures, including those with intra-articular extension, ipsilateral femultibia fractures proximal to a total knee arthroplasty, fractures distal to hip joint, nonunions and malunions, poly trauma patients, fractures in the morbidly obese, fractures involving osteopenic bone, compound and simple shaft fractures, proximal, metaphyseal, and distal shaft fractures, closed supracondylar fractures involving femoral condyles, comminuted fractures with bone loss, and periprosthetic fractures.

Device Description

The AUTOBAHN™ Nailing System is a family of intramedullary nails and screws designed to be used for internal bone fixation. The implants are available in various lengths and diameters to accommodate a wide range of patient anatomy. The nails are secured with locking screws and all devices are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or titanium molybdenum alloy, and may include radiolucent PEEK polymer inserts.

AI/ML Overview

This FDA 510(k) summary describes a medical device, the AUTOBAHN™ Nailing System, which is an intramedullary fixation rod. The summary aims to demonstrate its substantial equivalence to previously cleared predicate devices, rather than establishing de novo safety and effectiveness through clinical studies against specific acceptance criteria. Therefore, several aspects of your request (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth details) are not explicitly addressed in this type of submission.

However, I can extract the information available from the document that is relevant to acceptance criteria and performance, focusing on the engineering and mechanical testing methods typically used for this class of device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not explicitly stated in terms of specific numerical thresholds in this document, but implied by adherence to standards and comparison to predicates)	Reported Device Performance Summary (from "Performance Data" section)
Mechanical Performance (Nails and Screws) – Implied by ASTM F1264	Engineering analysis and mechanical testing (static and dynamic four-point and cantilever bending, static torsion, and cutout) was performed for nails and screws.
Biocompatibility / Sterility (Implied by standard for bacterial endotoxin)	Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Substantial Equivalence	Performance data demonstrates substantial equivalence to the predicate devices.
Technological Characteristics Equivalence	The AUTOBAHN™ Nailing System implants have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.

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

Test Set Sample Size: Not specified. The document refers to "engineering analysis and mechanical testing" which typically involves a number of samples tested per identified constraint or critical performance characteristic. Specific sample sizes for each test type (e.g., how many nails/screws for static bending) are not provided.
Data Provenance: Not applicable in the context of clinical data proving device performance on human subjects. This involves in vitro mechanical testing and engineering analysis. The testing was conducted by Globus Medical Inc. for its device.

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

Not applicable as this is a mechanical testing and engineering analysis submission, not a study involving human or expert assessment of clinical outcomes or images. "Ground truth" in this context would be the measured mechanical properties of the device and comparison to predicate device characteristics.

4. Adjudication Method for the Test Set

Not applicable as this device submission relies on mechanical testing and engineering analysis, not expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on the mechanical and technological equivalence of the device, not on diagnostic or clinical effectiveness that would involve human readers.

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

Not applicable. This device is an intramedullary Nailing System, a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence for this device would be:
- Mechanical Test Results: The measured mechanical properties (e.g., strength, fatigue life) of the AUTOBAHN™ Nailing System based on standardized testing methods (ASTM F1264).
- Material Properties: The chemical composition and physical properties of the materials used.
- Predicate Device Characteristics: The established design, intended use, material composition, function, and range of sizes of the legally marketed predicate devices.
- Standard Compliance: Adherence to relevant standards like ASTM F1264 and ANSI/AAMI ST-72:2011.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires training data.

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

Not applicable. This is not an AI/ML device.

Summary

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December 29, 2017

Globus Medical Inc. Kelly Baker Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K171108

Trade/Device Name: AUTOBAHN Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, JDS, HWC Dated: November 6, 2017 Received: November 7, 2017

Dear Kelly Baker:

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 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.

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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,

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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K171108

Device Name AUTOBAHN™ Nailing System

Indications for Use (Describe)

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)

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510(k) Summary: AUTOBAHN™ Nailing System

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Kelly J. Baker, Ph.D.Senior Vice President, Regulatory and Clinical Affairs
Date Prepared:	December 20, 2017
Device Name:	AUTOBAHN™ Nailing System
Common Name:	Intramedullary fixation rodSingle/multiple component metallic bone fixation appliancesand accessoriesSmooth or threaded metallic bone fixation fastener
Classification:	Per 21 CFR as follows:§888.3020 Intramedullary fixation rod§888.3030 Single/multiple component metallic bonefixation appliances and accessories§888.3040 Smooth or threaded metallic bone fixationfastenerProduct Code: HSB, JDS, HWCRegulatory Class: II, Panel Code: 87
Predicates:	Nail	Predicate Device
	Tibial	Synthes Tibial Nail System EX (K040762)*T2 Tibial Nailing System (K131365)TriGen® Meta-Nail Retrograde Femoral & TibialNails (K061019)Synthes Locking Screws (K000089)
	Trochanteric	Gamma3® Nail System (K043431)*Synthes Trochanteric Fixation Nail – AdvancedSystem (K131548)
	A/R Femoral	Zimmer Natural Nail System Retrograde FemoralNails (K101622)*Synthes Retrograde/Antegrade Femoral NailSystem (K033618)Zimmer Natural Nail System Piriformis Fossa &Greater Trochanter Antegrade Femoral Nails(K083497)T2 Femoral Nail (K112059)

Primary Predicates

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Purpose:

The purpose of this submission is to request clearance for the AUTOBAHN™ Nailing System.

Device Description:

Indications for Use:

The AUTOBAHN™ Tibial Nail is indicated for stabilization of fractures in skeletally mature patients, specifically fractures of the proximal and distal tibia and the tibial shaft, open and closed tibial shaft fractures, certain pre- and postisthmic fractures, non-unions, malunions, pseudarthrosis, corrective osteotomies, prophylactic nailing of impending pathological fractures, tumor resections, simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures, polytrauma and multiple fractures, reconstruction, following tumor resection and grafting, supracondylar fractures, and bone lengthening and shortening.

The AUTOBAHN™ Trochanteric Nail is indicated for treatment of fractures in adults and adolescents (12-21 years of age) in which the growth plates have fused for the following indications: basal neck fractures, fixation of stable and unstable intertrochanteric, pertrochanteric, and subtrochanteric fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, combinations of pertrochanteric, intertrochanteric, basal neck fractures, long subtrochanteric fractures, tumor resections, fractures resulting from trauma, nonunions, malunions, and revision procedures.

AUTOBAHN™ Antegrade/Retrograde Femoral Nails are indicated for long bone fracture fixation in skeletally mature patients, specifically femoral fracture fixation, which may include the following: open and closed femoral fractures, pseudoarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, supracondylar fractures, including those with intra-articular extension, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures, fractures proximal to a total knee arthroplasty, fractures distal to hip joint, nonunions and malunions, poly trauma patients, fractures in the morbidly obese, fractures involving osteopenic and osteoporotic bone, compound and simple shaft fractures, proximal, metaphyseal, and distal shaft fractures, segmental fractures, closed supracondylar fractures involving femoral condyles, comminuted fractures, fractures with bone loss, and periprosthetic fractures.

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Performance Data:

Performance of the AUTOBAHN™ Nailing System was evaluated in accordance with ASTM F1264. Engineering analysis and mechanical testing (static and dynamic four-point and cantilever bending, static torsion, and cutout) was performed for nails and screws. Performance data demonstrates substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

Technological Characteristics:

The AUTOBAHN™ Nailing System implants have the same technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.

Conclusions:

The AUTOBAHN™ Nailing System has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the 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.