The Femoral Neck System (FNS) is indicated for basilar femoral neck fractures in adults and adolescents (12-21) in which the growth plates have fused or will not be crossed.

Device Description

The subject Femoral Neck System is comprised of implants designed to treat basilar femoral neck fractures as well as system-specific insertion instruments. The Femoral Neck System is a modular system consisting of four connected implant components forming a fixed-angle gliding fixation device which allows for controlled collapse of the femoral head. The implants are manufactured from Titanium Alloy and are provided in a range of dimensions. The same construct can be used for the left and right femur.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study related to an AI/ML medical device. The document is an FDA 510(k) clearance letter for the DePuy Synthes Femoral Neck System, a metallic bone fixation appliance.

Therefore, I cannot provide a response to the prompt's request for acceptance criteria and study details for an AI/ML device.

Summary

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March 5, 2018

DePuy Synthes Ana Roca Regulatory Affairs Specialist DePuy Synthes Luzernstrasse 21 4528 Zuchwil, Switzerland

Re: K172872

Trade/Device Name: DePuy Synthes Femoral Neck System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: January 26, 2018 Received: January 29, 2018

Dear Ana Roca:

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 (QS) regulation (21 CFR Part 820);

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Page 2 - Ana Roca

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 mediation-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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Indications for Use

510(k) Number (if known) K172872

Device Name DePuy Synthes Femoral Neck System

Indications for Use (Describe)

The Femoral Neck System (FNS) is indicated for basilar femoral neck fractures in adults and adolescents (12-21) in which the growth plates have fused or will not be crossed.

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)

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K172872 510(k) Summary
Sponsor	DePuy SynthesAna Sala RocaLuzernstrasse 214528 Zuchwil, SwitzerlandPhone: +41 32 720 45 73Fax: +41 32 720 71 73
Date Prepared	March 01, 2018
Proprietary Name	DePuy Synthes Femoral Neck System
Classification Name	Single/multiple component metallic bone fixation appliances and accessories
Classification	Class IIRegulation Number: 21 CFR 888.3030Product Code: KTT
Predicate device	Predicate device:Synthes Dynamic Hip Screw System (K791619)Predicate device:Omega 3 System (K062066)
Reference Device	Reference Device:Synthes Titanium Limited Contact Dynamic Hip Screw (Ti.LC-DHS) ImplantSystem (K953607)
	Reference Device:DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws,DePuy Synthes 2.4 mm Cannulated Screws,DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws,DePuy Synthes 4.5 mm Cannulated Screws,DePuy Synthes 6.5 mm Cannulated Screws,DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws,DePuy Synthes 1.5 mm Headless Compression Screws,DePuy Synthes 2.4 mm Headless Compression Screws,DePuy Synthes 3.0 mm Headless Compression Screws,DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw(K161616)
Device Description	The subject Femoral Neck System is comprised of implants designed to treat basilarfemoral neck fractures as well as system-specific insertion instruments. The FemoralNeck System is a modular system consisting of four connected implant componentsforming a fixed-angle gliding fixation device which allows for controlled collapse ofthe femoral head.
	The implants are manufactured from Titanium Alloy and are provided in a range ofdimensions. The same construct can be used for the left and right femur.
Indications for Use	The Femoral Neck System (FNS) is indicated for basilar femoral neck fractures inadults and adolescents (12-21) in which the growth plates have fused or will not becrossed.
Non-clinicalPerformance Data	Static bending, cyclic fatigue and rotational resistance testing of constructs has beenperformed to compare the subject DePuy Synthes Femoral Neck System to thePredicate device Dynamic Hip Screw System. This information supports that themechanical performance of the subject system is at least equivalent to that of thePredicate device.
	Magnetic Resonance compatibility testing has been performed to establish MRConditional parameters for the subject DePuy Synthes Femoral Neck System.
	The devices also meet the specified endotoxin requirement of 20EU/device using theLAL test method.
ClinicalPerformance Data	Clinical testing was not necessary for the determination of substantial equivalence.
	The subject system has similar intended use as the Predicate devices. Theindications of the subject system are a subset of the indications of the Predicatedevices.
Comparison toPredicate	The subject system, like the Predicate devices, is a fixed-angle fixation devicethat allows for controlled collapse of the femoral head. These systems are modularsystems applied through a standard lateral approach and fixed on the lateral cortexof the femur. Systems are available sterile.
	The subject system presents several technological characteristics that are notfound in the Predicate devices:
	● In contrast to the Predicate devices, the plates of the subject system areavailable with a one hole design.
	● When compared to the Predicate devices, the subject system features anadditional fixation point in the femoral head by design. In addition, thesliding component of the subject system comprises two interlocked partsinstead of one.
	● While the Subject device is made from Titanium Alloy (TiAl6Nb7), thePredicate devices are made from Stainless Steel (316L).
	Mechanical testing demonstrates substantial equivalence of the Subject device to thePredicate DHS device in regards to mechanical strength. Furthermore, the subjectsystem and the reference device (K953607), both used in the same anatomicallocation and with a similar intended use, are made from Titanium Alloy(TiAl6Nb7).
	Both Predicate devices provide the surgeon with an option for a second point offixation in the femoral head and result in a construct configuration that occupies asimilar volume and position in the femoral neck and head.It can be concluded that features of the Subject device are substantially equivalent tothe Predicate devices based on the similarities in intended use and design.
	The subject system has similar intended use as the predicate and reference devices.The subject system has similar indications for use and it is similar in design andfundamental technology as compared to the Predicate devices. The raw materialtype of the subject system and reference device is the same.
Substantial Equivalence	The mechanical testing included in this submission supports that:
	● Any differences in technological characteristics from the Predicate devices do notraise any new questions of safety and effectiveness.
	● The Subject devices are at least as safe and effective as the Predicate devices.
	It is concluded that the information provided in this submission supports substantialequivalence.

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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.