(258 days)
Not Found
No
The summary describes a mechanical implant system for stabilizing bone fractures and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to stabilize fractures of the distal femur and femoral shaft, which directly treats a medical condition (fractures).
No
This device is an implantable medical device (femoral nail) used for stabilizing fractures, not for diagnosing medical conditions.
No
The device description explicitly states it is a modular system incorporating several components made from titanium alloys, stainless steel, and polyethylene, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for stabilizing fractures of the distal femur and femoral shaft. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a modular system of implants (nails, screws, etc.) made from titanium alloys, stainless steel, and polyethylene. These are materials used for surgical implants, not for testing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing. IVDs are typically used in laboratories or point-of-care settings for diagnostic purposes.
Therefore, the DePuy Synthes Retrograde Femoral Nail Advanced System is a surgical implant used for orthopedic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including:
- Supracondylar fractures, including those with intra-articular extension
- Combination of ipsilateral condylar and diaphyseal fractures
- Ipsilateral femur/tibia fractures
- Femoral fractures in multiple trauma patients
- Periprosthetic fractures
- Fractures in the morbidly obese
- Fractures in osteoporotic bone
- Impending pathologic fractures
- Malunions and nonunions
Product codes
HSB, HWC
Device Description
The DePuy Synthes Retrograde Femoral Nail Advanced System was developed to address challenges associated with treating distal femur fractures with intramedullary nails. The modular system incorporates several components to a variety of fracture patterns including those in the presence of previously implanted devices such as the femoral components of a total knee arthroplasty (periprosthetic). The nailing implants are available in two distal bend configurations which enable standard and periprosthetic entry points for the insertion of the femur. The nailing system implants are manufactured from titanium alloys, stainless steel and polyethylene and are provided in a range of dimensions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur, femoral shaft
Indicated Patient Age Range
Not Found
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 testing was performed on the subject RFN-A with the inlay removed, in order to adequately assess substantial equivalence against the predicate RFN-A (as provided, with the inlay). A non-inferior change to screw cut through was observed when testing the subject RFN-A with the inlay removed, vs. the predicate RFN-A as provided, with the inlay.
Additionally, the RFN-A Nail without inlay + Locking Attachment Washer (LAW) construct demonstrated a higher superior peak cutout force when subjected to static loading in a foam model compared to the RFN-A Nail without inlay + locking screws construct.
Additionally, MR testing was performed to substantiate the MR Conditional claim for the RFN-A Nail.
The tests results meet established acceptance criteria to support the substantial equivalence determination of the subject device with the inlay removed vs. the predicate RFN-A with the inlay.
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.
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
August 1, 2024
Image /page/0/Picture/1 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Depuy Synthes Rebecca Reiter Senior Regulatory Affairs Program Lead 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K233696
Trade/Device Name: DePuy Synthes Retrograde Femoral Nail Advanced System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: July 3, 2024 Received: July 3, 2024
Dear Rebecca Reiter:
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.
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" (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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve
1
changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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.
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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Farzana
Digitally signed by
Farzana Sharmin -S
Sharmin -S Date: 2024.08.01
10:29:27 -04'00'
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
2
Indications for Use
Submission Number (if known)
Device Name
DePuy Synthes Retrograde Femoral Nail Advanced System
Indications for Use (Describe)
The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including:
- Supracondylar fractures, including those with intra-articular extension
- Combination of ipsilateral condylar and diaphyseal fractures
- Ipsilateral femur/tibia fractures
- Femoral fractures in multiple trauma patients
- Periprosthetic fractures
- Fractures in the morbidly obese
- Fractures in osteoporotic bone
- 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)
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3
510(k) #: K233696
510(k) Summary
Prepared on: 2024-07-30
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Depuy Synthes | |||
|---|---|---|---|---|
| Applicant Address | 1301 Goshen Parkway West Chester PA 19380 United States | |||
| Applicant Contact Telephone | +1-610-719-1268 | |||
| Applicant Contact | Mrs. Rebecca Reiter | |||
| Applicant Contact Email | rreiter@its.jnj.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | DePuy Synthes Retrograde Femoral Nail Advanced System | |||
| Common Name | Intramedullary fixation rod | |||
| Classification Name | Rod, Fixation, Intramedullary And Accessories | |||
| Regulation Number | 888.3020 | |||
| Product Code(s) | HSB, HWC | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System | HSB | ||
| K033618 | Synthes Retrograde/Antegrade Femoral Nail | HSB | ||
| Device Description Summary | 21 CFR 807.92(a)(4) |
The DePuy Synthes Retrograde Femoral Nail Advanced System was developed to address challenges associated with treating distal femur fractures with intramedullary nails. The modular system incorporates several components to a variety of fracture patterns including those in the presence of previously implanted devices such as the femoral components of a total knee arthroplasty (periprosthetic). The nailing implants are available in two distal bend configurations which enable standard and periprosthetic entry points for the insertion of the femur. The nailing system implants are manufactured from titanium alloys, stainless steel and polyethylene and are provided in a range of dimensions.
Intended Use/Indications for Use
The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femoral shaft, including:
- Supracondylar fractures, including those with intra-articular extension
- Combination of ipsilateral condylar and diaphyseal fractures
- Ipsilateral femur/tibia fractures
- Femoral fractures in multiple trauma patients
- Periprosthetic fractures
- Fractures in the morbidly obese
- Fractures in osteoporotic bone
- Impending pathologic fractures
21 CFR 807.92(a)(5)
4
Indications for Use Comparison
The subject DePuy Synthes Retrograde Femoral Nail Advanced System has the same intended use, indications for use and principles of operation, and similar technological characteristics as compared to the predicate and reference between the subject device and the predicate is the option to remove the prior to intraoperative placement. This added option does not present any new concerns of safety or effectiveness as compared to the predicate device cleared under K201346 and reference device cleared under K033618. Thus, the DePuy Synthes Retrograde Femoral Nailing Advanced System is substantially equivalent to the DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0mm (K201346).
Technological Comparison
21 CFR 807.92(a)(6)
The subject Retrograde Femoral Nailing Advanced (RFN-A) System has the same intended use, indications for use and principles of operation, and similar technological characteristics as compared to the predicate and reference between the subject device and the predicate is the option to remove the polymer intraoperative placement. This added option does not present any new concerns of safety or effectiveness as compared to the predicate device cleared under K201346. Thus, the DePuy Synthes RFN-A System is substantially equivalent to the DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0mm (K201346).
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical testing was performed on the subject RFN-A with the inlay removed, in order to adequately assess substantial equivalence against the predicate RFN-A (as provided, with the inlay). A non-inferior change to screw cut through was observed when testing the subject RFN-A with the inlay removed, vs. the predicate RFN-A as provided, with the inlay.
Additionally, the RFN-A Nail without inlay + Locking Attachment Washer (LAW) construct demonstrated a higher superior peak cutout force when subjected to static loading in a foam model compared to the RFN-A Nail without inlay + locking screws construct.
Additionally, MR testing was performed to substantiate the MR Conditional claim for the RFN-A Nail.
The tests results meet established acceptance criteria to support the substantial equivalence determination of the subject device with the inlay removed vs. the predicate RFN-A with the inlay.