(56 days)
No
The summary describes a mechanical plating system for bone fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an implantable plate system designed to provide fixation and stabilization for patellar fractures to aid bone healing, not to treat a disease or condition itself.
No
The device is a surgical implant designed for fixation and stabilization of patellar fractures, not for diagnosing conditions.
No
The device description explicitly states it is comprised of "single-use, sterile implants" and "sterile, non-implantable templates," which are physical hardware components.
Based on the provided information, 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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The DePuy Synthes Variable Angle Locking Patella Plating System is described as a system of implants (plates and screws) and templates used for the fixation and stabilization of patellar fractures. These are physical devices that are surgically placed within the body.
- Intended Use: The intended use is for the fixation and stabilization of patellar fractures, which is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant system, not a diagnostic tool that analyzes biological samples.
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 single-use, sterile implants which will be placed on the lateral rim and on the anterior surface of the fractured patella to provide fixation during bone healing. The system offers both a small and a large plate to provide fixation for various patella fracture patterns. The subject plates are available sterile and are manufactured from implant grade stainless steel or 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
Mechanical testing of constructs (plate with screws) under static and dynamic loading conditions have been performed to demonstrate that the proposed DePuy Synthes Variable Angle Locking Patella Plating System performs substantially equivalent to the predicate and reference 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 testing was not necessary for the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
DePuy Synthes Variable Angle Locking Patella Plating System (K201578)
Reference Device(s)
Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System (K100776)
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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April 8, 2021
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Synthes (USA) Products, LLC Enrico Gindro Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K210408
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: February 10, 2021 Received: February 11, 2021
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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (0S) 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 mediation-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,
Shumaya Ali -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Stereotaxic. Trauma and Restorative Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210408
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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510(k) Summary
| Sponsor | DePuy Synthes
Enrico Gindro
1301 Goshen Parkway
West Chester, PA 19380
Phone: +41 79 912 73 59 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date prepared | February 10, 2021 |
| 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 | DePuy Synthes Variable Angle Locking Patella Plating System (K201578) |
| Reference 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 single-use, sterile implants which will be placed on the
lateral rim and on the anterior surface of the fractured patella to provide
fixation during bone healing. The system offers both a small and a large
plate to provide fixation for various patella fracture patterns. The subject
plates are available sterile and are manufactured from implant grade
stainless steel or 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 | Intended use, indications for use, basic design features, technology,
screw type compatibility, and sterility of the subject plates are identical
to the predicate cleared under K201578. |
| | The subject device is placed along the lateral rim of the patella with a
portion of the plate extending across the anterior surface of the patella,
whereas the predicate is placed on the anterior surface of the patella
with a portion of the plate extending to the rim of the patella. Compared
to the predicate device the subject plates offer additional screw holes to
provide bi-cortical fixation along the lateral rim of the patella and fewer
fixation points on the anterior portion of the plate. |
| | 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 | Mechanical testing of constructs (plate with screws) under static and
dynamic loading conditions have been performed to demonstrate that
the proposed DePuy Synthes Variable Angle Locking Patella Plating
System performs substantially equivalent to the predicate and reference
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. |
| | Based on the indications for use, technological characteristics, and the
summary of data submitted, DePuy Synthes has determined that the
proposed device is substantially equivalent to the currently marketed
predicate device. |
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