AUTOBAHN™ Nailing System

K261043 · Globus Medical, Inc. · HSB · Apr 24, 2026 · Orthopedic

Device Facts

• Record ID: K261043
• Device Name: AUTOBAHN™ Nailing System
• Applicant: Globus Medical, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Apr 24, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 (including osteoporotic and osteopenic bone), 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™ EVO 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, fractures involving femoral condyles, comminuted fractures, fractures with bone loss, and periprosthetic fractures. In addition, the AUTOBAHN® EVO Antegrade Nails are intended for use in adolescents (12-21 years) in which the growth plates have fused.

Device Story

Intramedullary nailing system for internal bone fixation; includes nails, screws, washers, and new Hip Fastener with helical hook thread geometry. Used by orthopedic surgeons in clinical/surgical settings for fracture stabilization. Device inputs are patient anatomical requirements; outputs are mechanical fixation of bone segments. Helical hook geometry provides enhanced fixation compared to standard cancellous threads. Benefits include improved stability for complex fractures, including osteoporotic bone. System is a line extension of existing AUTOBAHN™ platform.

Clinical Evidence

Bench testing only. Performance data includes cutout testing, insertion torque, and static torsion testing conducted in accordance with ASTM F543 to demonstrate equivalence.

Technological Characteristics

Intramedullary fixation system; titanium alloy construction. Features helical hook thread geometry for hip fasteners. Dimensions vary to accommodate patient anatomy. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for adults and adolescents (12-21 years) with fused growth plates requiring fixation of femoral, trochanteric, and diaphyseal fractures, including pathologic, osteoporotic, osteopenic, and periprosthetic fractures, nonunions, malunions, and revision procedures.

Regulatory Classification

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.

Predicate Devices

• AUTOBAHN™ Nailing System (K171108)
• Stryker Gamma3 System (K200869)
• AUTOBAHN™ EVO Femoral Nails (K220659)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 24, 2026

Globus Medical, Inc.
Suganya Gopalakrishnan
Regulatory Specialist
Globus Medical, Inc.
2560 General Armistead Ave.,
Audubon, PA 19403

Re: K261043
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: March 30, 2026
Received: March 31, 2026

Dear Suganya Gopalakrishnan:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K261043 - Suganya Gopalakrishnan
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K261043 - Suganya Gopalakrishnan
Page 3

Sincerely,

FARZANA SHARMIN -S

Farzana Sharmin, 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

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
**Indications for Use** | Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below. |
| --- | --- |

510(k) Number (if known)<br/>K261043

Device Name<br/>AUTOBAHN™ Nailing System

Indications for Use (Describe)

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 (including osteoporotic and osteopenic bone), 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® EVO 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, fractures involving femoral condyles, comminuted fractures, fractures with bone loss, and periprosthetic fractures. In addition, the AUTOBAHN® EVO Antegrade Nails are intended for use in adolescents (12-21 years) in which the growth plates have fused.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)<br/>☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K261043 - Page 1 of 3

# 510(k) Summary: AUTOBAHN™ Nailing System

Company: Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800

Primary Contact: Suganya Gopalakrishnan
Regulatory Specialist

Secondary Contact: Jennifer Antonacci, Ph.D.
Director, Regulatory Affairs

Date Prepared: April 22, 2026

Device Name: AUTOBAHN™ Nailing System

Common Name: Intramedullary fixation rod; Bone fixation fastener

Classification: Per 21 CFR as follows:
§888.3020 Intramedullary fixation rod
§888.3030 Single/multiple component metallic bone fixation appliances and accessories
§888.3040 Smooth or threaded metallic bone fixation fastener
Product Code: HSB, JDS, HWC
Regulatory Class: II, Panel Code: 87

Primary Predicate: AUTOBAHN™ Nailing System (K171108)

Additional Predicates: Stryker Gamma3 System (K200869)
AUTOBAHN™ EVO Femoral Nails (K220659)

Purpose: The purpose of this submission is to request clearance for the AUTOBAHN™ Hip Fastener with Helical Hook Technology, as a line extension to the AUTOBAHN™ Nailing System. Additional minor updates to the indications for use, and additional compatibility of previously cleared AUTOBAHN™ EVO screws for use with the AUTOBAHN™ Trochanteric Nails are also included.

Device Description: The AUTOBAHN™ Nailing System is a family of intramedullary nails, screws and washers designed to be used for internal bone fixation. The implants are available in various lengths and diameters to accommodate a wide range of patient

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K261043 - Page 2 of 3

anatomy. AUTOBAHN™ Hip Fastener with Helical Hook Technology is a hip fixation fastener with helical hook thread geometry for use with the AUTOBAHN™ Trochanteric Nails. The Hip Fastener implants are available in various lengths and a single diameter. The hip fastener implants are manufactured from titanium alloy.

## Indications for Use:

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 (including osteoporotic and osteopenic bone), 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™ EVO 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, fractures involving femoral condyles, comminuted fractures, fractures with bone loss, and periprosthetic fractures. In addition, the AUTOBAHN™ EVO Antegrade Nails are intended for use in adolescents (12-21 years) in which the growth plates have fused.

## Performance Data:

Cutout testing of the AUTOBAHN™ Hip Fastener with Helical Hook Technology was conducted to demonstrate substantial equivalence to the predicate devices. Insertion torque and static torsion testing were also conducted on the AUTOBAHN™ Hip Fastener in accordance with ASTM F543.

## Technological Characteristics:

Subject AUTOBAHN™ implants have similar technological characteristics as the predicate devices including overall design, intended use, material composition, function, and range of sizes. The primary difference is the thread geometry; the subject device is designed with helical hook thread geometry as compared to the standard cancellous threads for the predicate device.

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K261043 - Page 3 of 3

## Basis of Substantial Equivalence:

The subject AUTOBAHN™ Nailing System implants have been found to be substantially equivalent to the predicate device with respect to technical characteristics, performance, and intended use. The information provided supports substantial equivalence to the predicate device.