(165 days)
No
The summary describes a mechanical implant system and its associated instruments, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is an implant designed to treat basilar femoral neck fractures, which functions to restore the integrity and function of the femoral neck, thus providing a therapeutic effect.
No
Explanation: The device, the Femoral Neck System (FNS), is described as implants and instruments designed to treat (fix) basilar femoral neck fractures, not to diagnose them.
No
The device description explicitly states it is comprised of implants and insertion instruments, which 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Femoral Neck System is an implantable device designed to treat bone fractures. It is surgically inserted into the body.
- Intended Use: The intended use is to fix basilar femoral neck fractures, which is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The information provided clearly describes a surgical implant and its associated instruments, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral neck; femoral head; femur
Indicated Patient Age Range
adults and adolescents (12-21)
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)
Non-clinical Performance Data:
Static bending, cyclic fatigue and rotational resistance testing of constructs has been performed to compare the subject DePuy Synthes Femoral Neck System to the Predicate device Dynamic Hip Screw System. This information supports that the mechanical performance of the subject system is at least equivalent to that of the Predicate device.
Magnetic Resonance compatibility testing has been performed to establish MR Conditional parameters for the subject DePuy Synthes Femoral Neck System.
The devices also meet the specified endotoxin requirement of 20EU/device using the LAL test method.
Clinical Performance Data:
Clinical testing was not necessary for the determination of substantial equivalence.
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.
Synthes Dynamic Hip Screw System (K791619), Omega 3 System (K062066)
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.
Synthes Titanium Limited Contact Dynamic Hip Screw (Ti.LC-DHS) Implant System (K953607), DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws (K161616), DePuy Synthes 2.4 mm Cannulated Screws (K161616), DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws (K161616), DePuy Synthes 4.5 mm Cannulated Screws (K161616), DePuy Synthes 6.5 mm Cannulated Screws (K161616), DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws (K161616), DePuy Synthes 1.5 mm Headless Compression Screws (K161616), DePuy Synthes 2.4 mm Headless Compression Screws (K161616), DePuy Synthes 3.0 mm Headless Compression Screws (K161616), DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw (K161616)
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
§ 888.3030 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
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 Synthes |
| Ana Sala Roca | |
| Luzernstrasse 21 | |
| 4528 Zuchwil, Switzerland | |
| Phone: +41 32 720 45 73 | |
| Fax: +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 II |
| Regulation Number: 21 CFR 888.3030 | |
| Product 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) Implant | |
| System (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 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. | |
| Indications for Use | 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. | |
| Non-clinical | |
| Performance Data | Static bending, cyclic fatigue and rotational resistance testing of constructs has been |
| performed to compare the subject DePuy Synthes Femoral Neck System to the | |
| Predicate device Dynamic Hip Screw System. This information supports that the | |
| mechanical performance of the subject system is at least equivalent to that of the | |
| Predicate device. | |
| Magnetic Resonance compatibility testing has been performed to establish MR | |
| Conditional parameters for the subject DePuy Synthes Femoral Neck System. | |
| The devices also meet the specified endotoxin requirement of 20EU/device using the | |
| LAL test method. | |
| Clinical | |
| Performance Data | Clinical testing was not necessary for the determination of substantial equivalence. |
| The subject system has similar intended use as the Predicate devices. The | |
| indications of the subject system are a subset of the indications of the Predicate | |
| devices. | |
| Comparison to | |
| Predicate | The subject system, like the Predicate devices, is a fixed-angle fixation device |
| that allows for controlled collapse of the femoral head. These systems are modular | |
| systems applied through a standard lateral approach and fixed on the lateral cortex | |
| of the femur. Systems are available sterile. | |
| The subject system presents several technological characteristics that are not | |
| found in the Predicate devices: | |
| ● In contrast to the Predicate devices, the plates of the subject system are | |
| available with a one hole design. | |
| ● When compared to the Predicate devices, the subject system features an | |
| additional fixation point in the femoral head by design. In addition, the | |
| sliding component of the subject system comprises two interlocked parts | |
| instead of one. | |
| ● While the Subject device is made from Titanium Alloy (TiAl6Nb7), the | |
| Predicate devices are made from Stainless Steel (316L). | |
| Mechanical testing demonstrates substantial equivalence of the Subject device to the | |
| Predicate DHS device in regards to mechanical strength. Furthermore, the subject | |
| system and the reference device (K953607), both used in the same anatomical | |
| location 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 of | |
| fixation in the femoral head and result in a construct configuration that occupies a | |
| similar volume and position in the femoral neck and head. | |
| It can be concluded that features of the Subject device are substantially equivalent to | |
| the 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 and | |
| fundamental technology as compared to the Predicate devices. The raw material | |
| type 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 not | |
| raise 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 substantial | |
| equivalence. |
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