(259 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of intramedullary nails and screws for bone fixation, with no mention of AI or ML technologies.
Yes
The device, the AUTOBAHN™ Nailing System, is an intramedullary nail and screw system used for internal bone fixation to stabilize fractures and treat various bone conditions, which directly addresses a health problem through structural correction.
No.
The AUTOBAHN™ Nailing System is an intramedullary nail system for internal bone fixation, indicated for the stabilization and treatment of various fractures. It is a therapy device, not a diagnostic one.
No
The device description explicitly states it is a family of intramedullary nails and screws made from titanium alloy, cobalt chromium molybdenum alloy, or titanium molybdenum alloy, and may include radiolucent PEEK polymer inserts. These are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- AUTOBAHN™ Nailing System Function: The AUTOBAHN™ Nailing System is a family of intramedullary nails and screws designed for internal bone fixation. It is surgically implanted into the bone to stabilize fractures.
- Lack of Specimen Analysis: The description clearly states the device's purpose is to fix bones. There is no mention of analyzing any biological specimens from the patient.
The device is a surgical implant used for orthopedic procedures, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HSB, JDS, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial shaft, femoral (femur), trochanteric, diaphyseal, hip joint
Indicated Patient Age Range
Skeletally mature patients, adults and adolescents (12-21 years of age)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K040762, K043431, K101622, K131365, K061019, K000089, K131548, K033618, K083497, K112059
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
1
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)
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.
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 19403
610-930-1800 | |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 rod
Single/multiple component metallic bone fixation appliances
and accessories
Smooth or threaded metallic 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 | |
| Predicates: | Nail | Predicate Device |
| | Tibial | Synthes Tibial Nail System EX (K040762)*
T2 Tibial Nailing System (K131365)
TriGen® Meta-Nail Retrograde Femoral & Tibial
Nails (K061019)
Synthes Locking Screws (K000089) |
| | Trochanteric | Gamma3® Nail System (K043431)*
Synthes Trochanteric Fixation Nail – Advanced
System (K131548) |
| | A/R Femoral | Zimmer Natural Nail System Retrograde Femoral
Nails (K101622)*
Synthes Retrograde/Antegrade Femoral Nail
System (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:
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.
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.