(90 days)
Not Found
No
The summary describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a fixation system for patellar fractures, aiding in bone healing rather than directly delivering a therapeutic substance or energy.
No
The device is described as a system for fixation and stabilization of patellar fractures, comprising implants and templates, indicating it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is comprised of implants and templates, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation and stabilization of patellar fractures." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is comprised of implants (plates and screws) that are surgically placed on the patella. This is a medical device used for treatment, not for analyzing biological samples.
- No mention of in vitro testing: The description focuses on mechanical testing of the implants and MR compatibility, not on any tests performed on biological specimens.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a fracture.
N/A
Intended Use / Indications for Use
The DePuy Synthes Variable Angle Locking Patella Plating System is indicated for the fixation and stabilization of patellar fractures in normal and osteopenic bone in skeletally mature patients.
Product codes
HRS
Device Description
The DePuy Synthes Variable Angle Locking Patella Plating System is comprised of implants which will be placed on the anterior surface of the fractured patella to provide fixation during bone healing. The system offers three plate configurations, in two sizes, to provide fixation for various patella fracture patterns and are available in implant grade stainless steel and titanium.
The system also consists of sterile, non-implantable templates that correspond to the implants. Templates are intended to help determine proper sizing and help predict contoured shape of the implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patellar fractures
Indicated Patient Age Range
skeletally mature patients
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)
Testing of constructs (plate with screws) under static and dynamic loading conditions have been performed to compare the proposed DePuy Synthes Variable Angle Locking Patella Plating System to the predicate device. This information supports that the mechanical performance of the subject devices is at least non-inferior to that of the predicate device.
Magnetic Resonance compatibility testing has been performed to establish MR Conditional parameters for the subject DePuy Synthes Variable Angle Locking Patella Plating System.
Endotoxin testing has been performed using to the LAL test method to establish that the subject DePuy Synthes Variable Angle Locking Patella Plating System meet the specified endotoxin requirement of 20 EU/device.
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
§ 888.3030 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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September 9, 2020
Image /page/0/Picture/1 description: The image shows 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 consists of 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 Enrico Gindro Regulatory Affairs Specilaist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K201578
Trade/Device Name: DePuy Synthes Variable Angle Locking Patella Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: June 8, 2020 Received: June 11, 2020
Dear Enrico Gindro:
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 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
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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 - Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
DePuy Synthes Variable Angle Locking Patella Plating System
Indications for Use (Describe)
The DePuy Synthes Variable Angle Locking Patella Plating System is indicated for the fixation and stabilization of patellar fractures in normal and osteopenic bone in skeletally mature patients.
| 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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K201578 - 510(k) Summary
| Sponsor | DePuy Synthes
Enrico Gindro
1301 Goshen Parkway
West Chester, PA 19380
Phone: +41 79 912 73 59 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date prepared | August 7, 2020 |
| Proprietary name | DePuy Synthes Variable Angle Locking Patella Plating System |
| Classification name | Single/multiple component metallic bone fixation appliances and
accessories |
| Classification | Class II |
| | Regulation Number: 21 CFR 888.3030 |
| | Product Code: HRS |
| Primary predicate
device | Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System
(K100776) |
| Device description | The DePuy Synthes Variable Angle Locking Patella Plating System is
comprised of implants which will be placed on the anterior surface of the
fractured patella to provide fixation during bone healing. The system
offers three plate configurations, in two sizes, to provide fixation for
various patella fracture patterns and are available in implant grade
stainless steel and titanium.
The system also consists of sterile, non-implantable templates that
correspond to the implants. Templates are intended to help determine
proper sizing and help predict contoured shape of the implant. |
| Indications for use | The DePuy Synthes Variable Angle Locking Patella Plating System is
indicated for the fixation and stabilization of patellar fractures in normal
and osteopenic bone in skeletally mature patients. |
| Contraindications | No contraindications specific to these devices. |
| Comparison to
predicate | The subject device has the same intended use as the predicate device.
The indications of the subject system are a subset of the indications of
the predicate device. |
| | The subject devices and the predicate device are metallic plates with a
low profile design intended for bone fracture fixation. Both subject and
predicate device are anatomically contoured plates and are compatible
with the same screw types. |
| | The subject devices present the following features that are not found in
the predicate device: |
| | • Subject devices are offered in a range of configurations and sizes
to accommodate patient anatomy and surgical need, whereas the
predicate device is available in a single configuration to be shaped
intraoperatively |
| | • Additional footprints shaped to the patellar anatomy to minimize
cutting time in the OR |
| | • The core plate curvature is spherical in nature based on patellar
anatomy to minimize intraoperative contouring time |
| | The subject devices are made from Stainless Steel (316L) or Commercially
Pure Titanium, while the predicate device is made from Stainless Steel
(316L) or Titanium Alloy (TAN). |
| | It can be concluded that features of the subject device are substantially
equivalent to the predicate device based on the similarities in intended
use and design. |
| Non-clinical
performance data | Testing of constructs (plate with screws) under static and dynamic
loading conditions have been performed to compare the proposed
DePuy Synthes Variable Angle Locking Patella Plating System to the
predicate device. This information supports that the mechanical
performance of the subject devices is at least non-inferior to that of the
predicate device. |
| | Magnetic Resonance compatibility testing has been performed to
establish MR Conditional parameters for the subject DePuy Synthes
Variable Angle Locking Patella Plating System. |
| | Endotoxin testing has been performed using to the LAL test method to
establish that the subject DePuy Synthes Variable Angle Locking Patella
Plating System meet the specified endotoxin requirement of
20 EU/device. |
| Clinical
performance data | Clinical testing was not necessary for the determination of substantial
equivalence. |
| Substantial
equivalence | The subject device has the same intended use compared to the
predicate device.
The non-clinical performance data as well as the comparison of design
features included in this premarket notification demonstrate that any
differences in technological characteristics of the subject device
compared to the predicate device do not raise any new questions of
safety and effectiveness.
It is concluded that the information provided herein supports
substantial equivalence of the subject devices. |
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