Who is the manufacturer of DePuy Synthes Variable Angle Locking Patella Plating System?

Synthes (USA) Products, LLC filed the 510(k) submission for DePuy Synthes Variable Angle Locking Patella Plating System (K210408).

What is the FDA product code for DePuy Synthes Variable Angle Locking Patella Plating System?

HRS. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for DePuy Synthes Variable Angle Locking Patella Plating System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DePuy Synthes Variable Angle Locking Patella Plating System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DePuy Synthes Variable Angle Locking Patella Plating System

K210408 · Synthes (USA) Products, LLC · HRS · Apr 8, 2021 · Orthopedic

Device Facts

Record ID	K210408
Device Name	DePuy Synthes Variable Angle Locking Patella Plating System
Applicant	Synthes (USA) Products, LLC
Product Code	HRS · Orthopedic
Decision Date	Apr 8, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

System consists of single-use, sterile metallic plates and non-implantable templates; used for fixation/stabilization of patellar fractures. Plates placed on lateral rim and anterior surface of fractured patella to provide fixation during bone healing. Available in small and large sizes to accommodate various fracture patterns. Operated by surgeons in clinical settings. Templates assist in sizing and contouring. Output is physical stabilization of bone fragments; aids clinical decision-making by providing structural support for healing. Benefits patient through fracture stabilization.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including mechanical testing of constructs (static/dynamic loading), MR compatibility testing, and endotoxin testing (LAL method, <20 EU/device).

Technological Characteristics

Materials: implant-grade stainless steel or titanium. Form factor: small/large plates with variable angle locking screw holes. Connectivity: none. Sterilization: sterile. Principle: mechanical bone fixation via locking plates and screws.

Indications for Use

Indicated for fixation and stabilization of patellar fractures in normal and osteopenic bone in skeletally mature patients.

Regulatory Classification

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.

Predicate Devices

DePuy Synthes Variable Angle Locking Patella Plating System (K201578)

Reference Devices

Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot / Midfoot System (K100776)

Related Devices

K201578 — DePuy Synthes Variable Angle Locking Patella Plating System · Synthes (USA) Products, LLC · Sep 9, 2020
K203408 — Summit Patella Plating System · Endeavor Orthopaedics, LLC · Jul 30, 2021
K192217 — NCB Plating System Distal Femur and Proximal Tibia · Zimmer GmbH · Sep 13, 2019
K152000 — SMV Scientific Bone Plate and Screw System · Smv Scientific · Nov 25, 2015
K993106 — SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES) · Smith & Nephew, Inc. · Dec 9, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) ### 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 gegarding 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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ # 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. | {4}------------------------------------------------