(106 days)
DePuy Synthes Femoral Recon Nail System (K172157)
No
The summary describes a system of physical implants and instruments for fracture fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "intramedullary nail" and "locking screws" intended for "temporary fixation and stabilization of tibia" to treat various fractures, malunions, and nonunions, which are all forms of therapy.
No
The described devices are implants (intramedullary nails and locking screws) used for the treatment and fixation of fractures, not for diagnosing conditions.
No
The device description explicitly states that the system is comprised of intramedullary nails, locking screws, end caps implants, and system-specific insertion instruments, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of fractures in adolescents by providing temporary fixation and stabilization of the tibia. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as intramedullary nails, locking screws, and insertion instruments. These are all physical implants and tools used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue), detect diseases or conditions, or provide information for diagnosis.
The device is a surgical implant system used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Tibial Nail Advanced implants are intended for treatment of fractures in adolescents (12-21) in which the growth plates have fused. Specifically, the implants are indicated for:
- · Open and closed proximal and distal tibial fractures
- Open and closed tibial shaft fractures
- · Tibial malunions and nonunions
DePuy Synthes Locking Screws are used for the static and dynamic interlocking of femoral, humeral and tibial nails.
Product codes (comma separated list FDA assigned to the subject device)
JDS, HWC
Device Description
DePuy Synthes Tibial Nail Advanced System:
The DePuy Synthes Tibial Nail Advanced System is a system comprised of intramedullary nails, locking screws, end caps implants, as well as system-specific insertion instruments. The Tibial Nail Advanced System is intended to be used for temporary fixation and stabilization of tibia. This system enables three different surgical approaches for the insertion of the nailing implant in the tibia: suprapatellar, parapatellar, and infrapatellar. The implants are manufactured from titanium alloys and provided in a range of dimensions to match individual patient anatomy. The intramedullary nailing implants are cannulated and can be inserted over a reaming rod. The nailing implants are offered in a range of proximal and distal shaft diameters and lengths to accommodate patient anatomy and surgical need related to the specific fracture patterns and locations. The nails will be manufactured from titanium alloy (Ti-6Al-4V) and polyetherketone (PEEK).
DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm:
The DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm have a diameter of 5 mm available in lengths ranging from 26 up to 120 mm and a diameter of 4 mm available in lengths ranging from 18 up to 80 mm. These implantable devices are fully threaded at the shaft and are self-tapping. The locking screws feature either a standard screw head or a low-profile screw head. The screws are made from titanium alloy (Ti-6Al-7Nb).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial, femoral, humeral
Indicated Patient Age Range
adolescents (12-21) in which the growth plates have fused
Intended User / Care Setting
Prescription Use
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 assessments used to characterize the subject device:
- LAL testing to demonstrate that the subject device meets the 20 EU/device limit set forth in FDA guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," dated January 21, 2016, when sterilized utilizing gamma radiation
- Biocompatibility assessment per FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," dated June 16, 2016
- Proximal and distal locking static torsion test of the construct according to ASTM F1264-16 A2.1.7
- MRI testing in accordance with standards ASTM F2052-14, ASTM F2213-06, ASTM F2182-11a, and ASTM F2119-07
Subject nailing implants were also evaluated against Synthes (USA) Tibial Nail System Ex (K040762):
- Static 4-point bending test of the nail shaft according to ASTM F1264-16 A1
- Torsion testing of the nail shaft according to ASTM F1264-16 A2
- Dynamic 4-point bending test of the nail shaft according to ASTM-16 A3
Subject locking screws were also evaluated against Synthes 4.0 and 5.0mm Locking Screws (K000089):
- Engineering analysis on static and cyclic 3-point bending of the locking screws according to ASTM F1264-16 A4
- Torsional properties of the locking screws according to ASTM F543-17 A1
- Driving torque of the locking screws according to ASTM F543-17 A2
- Driving torque and axial push out strength of the locking screws according to ASTM F543-17 A2 and A3
- Self-tapping performance of the locking screws according to ASTM F543-17 A4
This information supports that the performance of the subject device is substantially equivalent to that of the predicate device.
Clinical performance data was not deemed 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 (USA) Tibial Nail System Ex (K040762), Synthes 4.0 and 5.0 mm Locking Screws (K000089)
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.
DePuy Synthes Femoral Recon Nail System (K172157)
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.
0
Build Correspondence
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September 3, 2020
Synthes (USA) Products, LLC Pol Grebol Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380 USA
Re: K201336
Trade/Device Name: DePuy Synthes Tibial Nail Advanced System DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDS, HWC Dated: July 31, 2020 Received: August 3, 2020
Dear Pol Grebol:
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.
1
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 (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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-DICE website the assistance/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) K201336
Device Name
DePuy Synthes Tibial Nail Advanced System DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm
Indications for Use (Describe)
DePuy Synthes Tibial Nail Advanced System:
The Tibial Nail Advanced implants are intended for treatment of fractures in adolescents (12-21) in which the growth plates have fused. Specifically, the implants are indicated for:
- · Open and closed proximal and distal tibial fractures
- Open and closed tibial shaft fractures
- · Tibial malunions and nonunions
DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm:
DePuy Synthes Locking Screws are used 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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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 graphic to the left of the company name, which is written in a dark blue, sans-serif font. Below the company name, the text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" is written in a smaller, red font.
510(k) Summary
| Sponsor | DePuy Synthes
Pol Fort Grèbol
1301 Goshen Parkway
West Chester, PA 19380
Phone: +41 76 371 52 69
Fax: +41 32 720 71 73 |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | May 18, 2020 |
| Proprietary Name | DePuy Synthes Tibial Nail Advanced System
DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm |
| Classification Product
Code | JDS - Single/multiple component metallic bone fixation appliances and accessories
HWC - Smooth or threaded metallic bone fixation fastener |
| Device Classification
Name | Nail, Fixation, Bone
Screw, Fixation, Bone |
| Regulation Number /
Description | 21 CFR § 888.3030 - Single/multiple component metallic bone fixation appliances
and accessories
21 CFR § 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Device Classification | Class II |
| Predicate Devices | Primary Predicate Device:
Synthes (USA) Tibial Nail System Ex (K040762)
Additional Predicate Device:
Synthes 4.0 and 5.0 mm Locking Screws (K000089)
Reference Device:
DePuy Synthes Femoral Recon Nail System (K172157) |
| Device Description | DePuy Synthes Tibial Nail Advanced System:
The DePuy Synthes Tibial Nail Advanced System is a system comprised of
intramedullary nails, locking screws, end caps implants, as well as system-specific
insertion instruments. The Tibial Nail Advanced System is intended to be used for
temporary fixation and stabilization of tibia. This system enables three different
surgical approaches for the insertion of the nailing implant in the tibia: suprapatellar.
parapatellar, and infrapatellar. The implants are manufactured from titanium alloys
and provided in a range of dimensions to match individual patient anatomy.
The intramedullary nailing implants are cannulated and can be inserted over a
reaming rod. The nailing implants are offered in a range of proximal and distal shaft |
| | |
| | diameters and lengths to accommodate patient anatomy and surgical need related to
the specific fracture patterns and locations. The nails will be manufactured from
titanium alloy (Ti-6Al-4V) and polyetherketone (PEEK).
DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm:
The DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm have a
diameter of 5 mm available in lengths ranging from 26 up to 120 mm and a diameter
of 4 mm available in lengths ranging from 18 up to 80 mm. These implantable
devices are fully threaded at the shaft and are self-tapping. The locking screws
feature either a standard screw head or a low-profile screw head. The screws are
made from titanium alloy (Ti-6Al-7Nb). |
| Indications for Use | DePuy Synthes Tibial Nail Advanced System:
The Tibial Nail Advanced implants are intended for treatment of fractures in adults
and adolescents (12-21) in which the growth plates have fused. Specifically, the
implants are indicated for:
Open and closed proximal and distal tibial fractures Open and closed tibial shaft fractures Tibial malunions and nonunions
DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm:
DePuy Synthes Locking Screws are used for the static and dynamic interlocking of
femoral, humeral and tibial nails.
DePuy Synthes Tibial Nail Advanced System: |
| Comparison of
Technological
Characteristics with the
Predicate Device | Device comparison demonstrated that the DePuy Synthes Tibial Nail Advanced
System is substantially equivalent to the previsouly cleared Synthes (USA) Tibial
Nail System Ex (K040762) regarding intended use, indications for use,
technological characteristics (design features, material and performance) as well as
operating principle. At a high level, the subject device and predicate devices are
based on the following same technological elements:
Intramedulary nailing implants to provide fracture fixation and stabilization of the tibia Nail and screw design (length, diameter, shape) Nails, locking screws, and end caps manufactured from titanium alloys Hole configurations in proximal and distal part of nail Same locking options |
| Non-clinical
Performance Data | DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm: |
| | Device comparison demonstrated that the DePuy Synthes Locking Screws for
Medullary Nails, 4.0 and 5.0 mm is substantially equivalent to the previsouly cleared
Synthes 4.0 and 5.0 mm Locking Screws (K000089) regarding intended use,
indications for use, technological characteristics (design features, material and
performance) as well as operating principle. At a high level, the subject device and
predicate devices are based on the following same technological elements: |
| | Stabilization of intramedullary nail-bone construct Design (length, diameter, thread profile) Manufactured from titanium alloy Used for proximally and distally locking of nail-bone construct |
| | DePuy Synthes Tibial Nail Advanced System: |
| | The following non-clinical assessments were used to characterize the subject device
as a system: |
| | LAL testing to demonstrate that the subject device meets the 20 EU/device limit
set forth in FDA guidance document "Submission and Review of Sterility
Information in Premarket Notification (510(k)) Submissions for Devices
Labeled as Sterile," dated January 21, 2016, when sterilized utilizing gamma
radiation Biocompatibility assessment per FDA guidance document Use of International
Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process," dated June 16, 2016 Proximal and distal locking static torsion test of the construct according to
ASTM F1264-16 A2.1.7 MRI testing in accordance with standards ASTM F2052-14, ASTM F2213-06,
ASTM F2182-11a, and ASTM F2119-07 |
| | Subject nailing implants were also evaluated against Synthes (USA) Tibial Nail
System Ex (K040762): |
| | Static 4-point bending test of the nail shaft according to ASTM F1264-16 A1 Torsion testing of the nail shaft according to ASTM F1264-16 A2 Dynamic 4-point bending test of the nail shaft according to ASTM-16 A3 |
| | DePuy Synthes Locking Screws for Medullary Nails, 4.0 and 5.0 mm: |
| | Subject locking screws were also evaluated against Synthes 4.0 and 5.0mm Locking
Screws (K000089): |
| | Engineering analysis on static and cyclic 3-point bending of the locking screws
according to ASTM F1264-16 A4 |
| | Torsional properties of the locking screws according to ASTM F543-17 A1 Driving torque of the locking screws according to ASTM F543-17 A2 Driving torque and axial push out strength of the locking screws according to ASTM F543-17 A2 and A3 Self-tapping performance of the locking screws according to ASTM F543-17 A4 This information supports that the performance of the subject device is substantially equivalent to that of the predicate device. |
| Clinical
Performance Data | Clinical performance data was not deemed necessary for the determination of substantial equivalence. |
| | The proposed devices have the same intended use their predicate devices.
Additionally, the devices have similar indications for use, design principles, materials, and fundamental technology as compared to the predicate devices. |
| Substantial Equivalence | 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 |
| Conclusion | In conclusion, the results of non-clinical performance data demonstrate that the subject device is substantially equivalent with the predicate devices. |
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Image /page/4/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 graphic on the left and the company name on the right. The company name is in a dark blue font, and the words "PART OF THE" and "Johnson-Johnson FAMILY OF COMPANIES" are in a smaller, red font below the company name.
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Image /page/5/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 graphic on the left and the company name on the right. The company name is in a dark blue font, and the words "PART OF THE" and "Johnson-Johnson FAMILY OF COMPANIES" are in a smaller, red font below the company name.
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Image /page/6/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 graphic to the left of the company name. The company name is written in a dark blue font, with "DePuy" on the first line and "Synthes" on the second line. Below the company name is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller, red font.