(119 days)
Not Found
No
The summary describes a mechanical implant system for fracture stabilization and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implant designed to stabilize fractures in the femur, aiding in the treatment and healing process, which clearly aligns with the definition of a therapeutic device.
No
The device is an orthopedic implant (intramedullary nail) used for stabilization of bone fractures, not for diagnosing medical conditions.
No
The device description clearly states it is comprised of intramedullary nailing 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 Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes the Femoral Recon Nail System as an implantable device used for the surgical treatment of bone fractures in the femur. It is a physical device inserted into the body to stabilize bones.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples, detect biomarkers, or provide any diagnostic information about a patient's health status. Its function is purely therapeutic and structural.
The information provided aligns with a surgical implant used for orthopedic procedures, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for:
- Subtrochanteric fractures
- Ipsilateral neck/shaft fractures
- Femoral shaft fractures
- Impending pathologic fractures
- Malunions and nonunions
Product codes
HSB
Device Description
The Femoral Recon Nail (FRN) System is comprised of intramedullary nailing implants designed to provide stabilization of femoral shaft and neck fractures as well as system specific insertion instruments. The Femoral Recon Nail System offers nailing implants in two different designs which enable a Piriformis Fossa (PF) and a Greater Trochanter (GT) entry point for the insertion of the nailing implant in the femur. The implants are manufactured from Titanium alloy, are provided in a range of dimensions and in Left and Right-oriented versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral shaft and neck
Indicated Patient Age Range
adults and adolescents (12-21) in which the growth plates have fused.
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)
Fatigue testing of constructs with standard locking and recon locking as well as an analytical evaluation has been performed to compare the subject device DePuy Synthes Femoral Recon Nail System to the primary predicate device Synthes Lateral Entry Femoral Nail System. This information supports that the mechanical performance of the subject device is at least equivalent to that of the predicate device.
The devices also meet the specified endotoxin requirement of 20EU/device using the LAL test method.
Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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November 14, 2017
Synthes (USA) Products, LLC Alexander Zwahlen Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K172157
Trade/Device Name: DePuy Synthes Femoral Recon Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 17, 2017 Received: October 19, 2017
Dear Mr. Zwahlen:
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,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172157
Device Name
DePuy Synthes Femoral Recon Nail System
Indications for Use (Describe)
The Femoral Recon Nail System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for:
-
Subtrochanteric fractures
-
Ipsilateral neck/shaft fractures
-
Femoral shaft fractures
-
Impending pathologic fractures
-
Malunions and nonunions
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
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6 510(k) Summary
| Sponsor | DePuy Synthes
Alexander Zwahlen
1301 Goshen Parkway
West Chester, PA 19380
Phone: +41 32 720 41 04
Fax: +41 32 720 71 73 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | July 17, 2017 |
| Proprietary Name | DePuy Synthes Femoral Recon Nail System |
| Classification Name | Rod, Fixation, Intramedullary and Accessories |
| Classification | Class II
Regulation Number: 21 CFR 888.3020
Product Code: HSB |
| Predicate Devices | Primary Predicate Device:
Synthes Lateral Entry Femoral Nail System (K040336)
Additional Predicate Device:
Synthes Adolescent Lateral Entry Femoral Nail System (K070843)
Smith & Nephew Trigen Trochanteric Antegrade Nail (K040462) |
| Device Description | The Femoral Recon Nail (FRN) System is comprised of intramedullary nailing
implants designed to provide stabilization of femoral shaft and neck fractures as well
as system specific insertion instruments. The Femoral Recon Nail System offers
nailing implants in two different designs which enable a Piriformis Fossa (PF) and a
Greater Trochanter (GT) entry point for the insertion of the nailing implant in the
femur.
The implants are manufactured from Titanium alloy, are provided in a range of
dimensions and in Left and Right-oriented versions. |
| Indications for use | The Femoral Recon Nail System is intended for treatment of fractures in adults and
adolescents (12-21) in which the growth plates have fused. Specifically, the system
is indicated for:
- Subtrochanteric fractures
- Ipsilateral neck/shaft fractures
- Femoral shaft fractures
- Impending pathologic fractures
- Malunions and nonunions |
| Non-clinical
Performance Data | Fatigue testing of constructs with standard locking and recon locking as well as an
analytical evaluation has been performed to compare the subject device DePuy
Synthes Femoral Recon Nail System to the primary predicate device Synthes Lateral
Entry Femoral Nail System. This information supports that the mechanical
performance of the subject device is at least equivalent to that of the predicate
device.
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. |
| Substantial Equivalence | The proposed device has the same intended use as the predicate devices. The
proposed device has similar indications for use, are similar in design, material, and
fundamental technology as compared to the predicate devices. |
| | The mechanical testing and analytical evaluation included in this submission
demonstrate that: |
| | Any differences in technological characteristics of the predicate devices do not
raise any new questions of safety and effectiveness. |
| | The proposed 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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