(125 days)
Not Found
No
The summary describes a mechanical implant system and its components, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is an intramedullary nail system intended to stabilize fractures of the distal femur and femoral shaft, which is a structural support or fixation function, not a therapeutic one that would treat a disease or condition actively.
No
The device is an intramedullary nail system intended for stabilizing bone fractures, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly details physical components made of titanium alloys, stainless steel, and polyethylene, and the performance studies focus on mechanical properties of these materials and constructs.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that this device is a surgical implant (femoral nail and locking screws) used to stabilize bone fractures. It is a physical device implanted into the body, not used to test samples outside the body.
- Lack of IVD-related terms: The document does not mention any terms related to laboratory testing, analysis of biological samples, or diagnostic information derived from such testing.
Therefore, the DePuy Synthes Retrograde Femoral Nail Advanced System is a surgical device, not an In Vitro Diagnostic.
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
The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm are indicated for the static and dynamic interlocking of femoral, humeral and tibial nails.
Product codes
HSB, HWC
Device Description
The proposed Retrograde Femoral Nail Advanced System is being developed to address challenges associated with treating distal femur fractures with intramedullary nails. The system is modular in nature, incorporating several components to allow for the treatment of a variety of fracture patterns and 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 different bends which enable standard and periprosthetic entry points for the insertion of the nailing implant in the femur. The implants in this submission are manufactured from titanium alloys, stainless steel and polyethylene and are provided in a range of dimensions.
The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm feature a retaining screw head recess, additional shorter, rounded cutting flutes the ability to drive under power. The screws feature either a standard screw head or a low-profile screw head and are available with standard washers and nuts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur, femoral shaft, femoral, humeral, tibial nails
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 Performance Data:
The following analyses were conducted for the Retrograde Femoral Nail Advanced System
• Static Bend according to ASTM F1264
• Static Torsion according to ASTM F1264
• Dynamic Bend according to ASTM F1264
• Mechanical Static Construct
• Poly Inlay Screw Pull Out Test and Debris Evaluation
The following analyses were conducted for the DePuy Synthes Locking Screws for Medullary Nails, 5.0
• Torsional Properties according to ASTM F543
• Driving Torque & Axial Pushout according to ASTM F543
• Driving Torque according to ASTM F543
• Self-tapping Performance according to ASTM F543
• Finite Element Analysis for 3-Point Bending according to ASTM 1264
Other Additional Analysis:
• Endotoxin Testing was performed according to AAMI ST72
• MRI Conditional analysis has been performed to establish MR Conditional parameters for the subject implants however DePuy Synthes is choosing not to release these devices with MR Conditional labeling at this time
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)
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.
0
September 23, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Synthes (USA) Products, LLC Keith Knapp RA Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380 USA
Re: K201346
Trade/Device Name: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: August 20, 2020 Received: August 24, 2020
Dear Keith Knapp:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; 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 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,
For Michael Owens 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
510(k) Number (if known) K201346
Device Name
DePuy Synthes Retrograde Femoral Nail Advanced System DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
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
The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm are indicated for the static and dynamic interlocking of femoral, humeral and tibial nails.
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
Image /page/3/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol with three rings, followed by the company name in blue, and the tagline "People inspired" in a cursive font. The text "part of the Johnson & Johnson family of companies" is written in a smaller font below the company name.
5.
F 510(k) Summary
| Sponsor | DePuy Synthes
Keith Knapp
1301 Goshen Parkway
West Chester, PA 19380
Phone: +1-610-719-5942 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | May 19, 2020 |
| Proprietary Name | DePuy Synthes Retrograde Femoral Nail Advanced System
DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm |
| Device Common
Name | Rod, Fixation, Intramedullary And Accessories
Screw, Fixation, Bone |
| Classification Name | Intramedullary fixation rod.
Smooth or threaded metallic bone fixation fastener. |
| Classification | Class II
Regulation Number: 21 CFR 888.3020 & 888.3040
Product Code: HSB, HWC |
| Predicate Devices | Primary Predicate Devices:
Synthes Retrograde/Antegrade Femoral Nail (K033618)
Secondary Predicate Devices:
Synthes 4.0 and 5.0mm Locking Screws (K000089) |
| Device Description | The proposed Retrograde Femoral Nail Advanced System is being developed
to address challenges associated with treating distal femur fractures with
intramedullary nails. The system is modular in nature, incorporating several
components to allow for the treatment of a variety of fracture patterns and
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 different bends which enable
standard and periprosthetic entry points for the insertion of the nailing
implant in the femur. The implants in this submission are manufactured from
titanium alloys, stainless steel and polyethylene and are provided in a range
of dimensions.
The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm feature a
retaining screw head recess, additional shorter, rounded cutting flutes the
ability to drive under power. The screws feature either a standard screw head
or a low-profile screw head and are available with standard washers and nuts. |
| | The Retrograde Femoral Nail Advanced System is indicated to stabilize
fractures of the distal femur and femoral shaft, including: |
| Indications for use | - Supracondylar fractures, including those with intraarticular 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 non-unions |
| | The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm are indicated
for the static and dynamic interlocking of femoral, humeral and tibial nails. |
| Non-clinical
Performance Data | The following analyses were conducted for the Retrograde Femoral Nail
Advanced System
• Static Bend according to ASTM F1264
• Static Torsion according to ASTM F1264
• Dynamic Bend according to ASTM F1264
• Mechanical Static Construct
• Poly Inlay Screw Pull Out Test and Debris Evaluation
The following analyses were conducted for the DePuy Synthes Locking
Screws for Medullary Nails, 5.0
• Torsional Properties according to ASTM F543
• Driving Torque & Axial Pushout according to ASTM F543
• Driving Torque according to ASTM F543
• Self-tapping Performance according to ASTM F543
• Finite Element Analysis for 3-Point Bending according to ASTM 1264
Other Additional Analysis:
• Endotoxin Testing was performed according to AAMI ST72
• MRI Conditional analysis has been performed to establish MR
Conditional parameters for the subject implants however DePuy
Synthes is choosing not to release these devices with MR
Conditional labeling at this time |
| Clinical
Performance Data | Clinical testing was not necessary for the determination of substantial
equivalence. |
| Substantial
Equivalence | The proposed subject devices have the same intended uses as the predicate
devices. The proposed subject devices share similar or the same indications,
are similar in design, material, and fundamental technology with the
identified predicate devices. |
| | |
| The 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 | |
| In conclusion, the results of non-clinical performance data demonstrate that | |
| the subject device is substantially equivalent with the predicate devices. | |
4
Image /page/4/Picture/1 description: The image shows the logo for DePuy Synthes, which is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol with intersecting lines, followed by the text "DePuy Synthes" in a bold, dark blue font. To the right of the company name, the words "People inspired" are written in a cursive, light-colored font. The text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" is written in a smaller font below the company name.
5
Image /page/5/Picture/1 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo consists of a circular symbol to the left of the company name, which is written in a dark blue font. To the right of the company name, the phrase "People inspired" is written in a cursive font. The text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" is written in a smaller font below the company name.