(90 days)
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.
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.
Here's an analysis of the provided FDA 510(k) summary regarding the DePuy Synthes Variable Angle Locking Patella Plating System:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating non-inferiority of the subject device (DePuy Synthes Variable Angle Locking Patella Plating System) compared to a predicate device (Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System (K100776)) through mechanical testing.
| Acceptance Criteria (Implicit) | Reported Device Performance Statement |
|---|---|
| Mechanical Performance: The subject devices (plate with screws) must demonstrate mechanical performance that is at least non-inferior to the predicate device under static and dynamic loading conditions. | "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." |
| MR Compatibility: The subject device must establish MR Conditional parameters, indicating safe use in specific Magnetic Resonance environments. | "Magnetic Resonance compatibility testing has been performed to establish MR Conditional parameters for the subject DePuy Synthes Variable Angle Locking Patella Plating System." |
| Endotoxin Content: The subject device must meet specified endotoxin requirements (e.g., 20 EU/device). | "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." |
| Substantial Equivalence: Features of the subject device should not raise new questions of safety and effectiveness compared to the predicate device, based on similarities in intended use and design, and non-clinical performance data. | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the mechanical performance testing (e.g., number of plates/screws tested). It mentions "testing of constructs (plate with screws)," implying multiple test units.
- Test Set Sample Size: Not explicitly stated for mechanical testing.
- Data Provenance: The tests are described as "non-clinical performance data," indicating laboratory-based testing rather than patient data. The country of origin for the data is not specified, but the sponsor is Synthes (USA) Products, LLC in Pennsylvania, USA. The data is prospective as it was generated to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation is based on non-clinical, mechanical, and safety (MR compatibility, endotoxin) testing, not on clinical interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation is based on non-clinical, objective measurements rather than expert review of clinical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There was no MRMC comparative effectiveness study done. This device is a medical implant (bone fixation system) and not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a mechanical implant, not software or an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is primarily based on:
- Engineering Standards and Measurements: For mechanical performance (e.g., force, displacement, fatigue life), MR compatibility parameters, and endotoxin levels, the "ground truth" is defined by established engineering and safety standards, test methodologies, and measurable physical properties.
- Predicate Device Performance: The primary comparison is against the mechanical performance of a legally marketed predicate device, which serves as a benchmark for expected performance and safety.
8. The sample size for the training set
This information is not applicable as there is no mention of a "training set" in the context of this mechanical device's evaluation. It is not an AI/machine learning product.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this mechanical device.
{0}------------------------------------------------
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
{1}------------------------------------------------
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
{2}------------------------------------------------
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
PSC Publishing Services (301) 443-6740
EF
{3}------------------------------------------------
Image /page/3/Picture/0 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 design, the company name in blue, and the phrase "People inspired" in a light brown script font. The text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" is in a smaller font below the company name.
K201578 - 510(k) Summary
| Sponsor | DePuy SynthesEnrico Gindro1301 Goshen ParkwayWest Chester, PA 19380Phone: +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 andaccessories |
| Classification | Class II |
| Regulation Number: 21 CFR 888.3030 | |
| Product Code: HRS | |
| Primary predicatedevice | 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 iscomprised of implants which will be placed on the anterior surface of thefractured patella to provide fixation during bone healing. The systemoffers three plate configurations, in two sizes, to provide fixation forvarious patella fracture patterns and are available in implant gradestainless steel and titanium.The system also consists of sterile, non-implantable templates thatcorrespond to the implants. Templates are intended to help determineproper sizing and help predict contoured shape of the implant. |
| Indications for use | The DePuy Synthes Variable Angle Locking Patella Plating System isindicated for the fixation and stabilization of patellar fractures in normaland osteopenic bone in skeletally mature patients. |
| Contraindications | No contraindications specific to these devices. |
| Comparison topredicate | The subject device has the same intended use as the predicate device.The indications of the subject system are a subset of the indications ofthe predicate device. |
| The subject devices and the predicate device are metallic plates with alow profile design intended for bone fracture fixation. Both subject andpredicate device are anatomically contoured plates and are compatiblewith the same screw types. | |
| The subject devices present the following features that are not found inthe predicate device: | |
| • Subject devices are offered in a range of configurations and sizesto accommodate patient anatomy and surgical need, whereas thepredicate device is available in a single configuration to be shapedintraoperatively | |
| • Additional footprints shaped to the patellar anatomy to minimizecutting time in the OR | |
| • The core plate curvature is spherical in nature based on patellaranatomy to minimize intraoperative contouring time | |
| The subject devices are made from Stainless Steel (316L) or CommerciallyPure 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 substantiallyequivalent to the predicate device based on the similarities in intendeduse and design. | |
| Non-clinicalperformance data | Testing of constructs (plate with screws) under static and dynamicloading conditions have been performed to compare the proposedDePuy Synthes Variable Angle Locking Patella Plating System to thepredicate device. This information supports that the mechanicalperformance of the subject devices is at least non-inferior to that of thepredicate device. |
| Magnetic Resonance compatibility testing has been performed toestablish MR Conditional parameters for the subject DePuy SynthesVariable Angle Locking Patella Plating System. | |
| Endotoxin testing has been performed using to the LAL test method toestablish that the subject DePuy Synthes Variable Angle Locking PatellaPlating System meet the specified endotoxin requirement of20 EU/device. | |
| Clinicalperformance data | Clinical testing was not necessary for the determination of substantialequivalence. |
| Substantialequivalence | The subject device has the same intended use compared to thepredicate device.The non-clinical performance data as well as the comparison of designfeatures included in this premarket notification demonstrate that anydifferences in technological characteristics of the subject devicecompared to the predicate device do not raise any new questions ofsafety and effectiveness.It is concluded that the information provided herein supportssubstantial equivalence of the subject devices. |
{4}------------------------------------------------
{5}------------------------------------------------
§ 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.