(100 days)
The DePuy Synthes 2.4/2.7 mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long is intended for intra- and extra-articular fractures, osteotomies, nonunions of the distal radius, with or without extension into the radial diaphysis in adults and adolescents (12-21) where the growth plates have fused or will not be crossed, and the following adolescent distal radius fractures:
- Intra-articular fractures exiting the epiphysis
- Intra-articular fractures exiting the metaphysis
- Physeal crush injuries
- Any injuries which cause growth arrest to the distal radius.
The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long will be available in stainless steel and titanium. The head of the plate will remain the same as the existing 2.4mm VA-LCP Two-Column Volar Distal Radius Plate (K102694) and will therefore allow the use of the existing guide block for these plates. The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long will come in 3 different lengths (7 shaft holes, 10 shaft holes and 13 shaft holes). To accommodate different patient anatomy, the plate with 7 shaft holes will be available with three different plate head widths (Standard, Narrow and Wide). The 10 shaft hole and the 13 shaft hole plate will only be released with the Standard plate head width and additionally they feature a curvature in the shaft. All plates will feature left- and right-specific designs and will be offered in sterile packed only.
The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plates, Extra-Long are designed to accept existing 2.4mm Variable Angle Locking Screws, 2.4mm Cortex Screws, 2.4mm Locking Screws, 1.8mm VA Buttress Pins and 1.8mm Locking Buttress Pins in the plate head holes. In the plate shaft, existing 2.4mm Cortex Screws, 2.7mm Cortex Screws, 2.4mm Variable Angle Locking Screws, 2.7mm Variable Angle Locking Screws, 2.4mm Locking Screws, and 2.7mm Locking Screws can be inserted.
This 510(k) premarket notification is for a medical device called the "DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long". It is a metallic bone fixation appliance and accessories. This document does not describe the acceptance criteria or studies for an AI/ML device. It focuses on the substantial equivalence of a physical medical implant to existing predicate devices through mechanical and biocompatibility testing. Therefore, I cannot provide the requested information.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2017
DePuy Synthes Joanna Rieder Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K163046
Trade/Device Name: DePuy Synthes 2.4/2.7mm Va Lcp Two-column Volar Distal Radius Plate, Extra-long 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: January 10, 2017 Received: January 11, 2017
Dear Joanna Rieder:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163046
Device Name
DePuy Synthes 2.4/2.7 mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long
Indications for Use (Describe)
INDICATIONS
The DePuy Synthes 2.4/2.7 mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long is intended for intra- and extra-articular fractures, osteotomies, nonunions of the distal radius, with or without extension into the radial diaphysis in adults and adolescents (12-21) where the growth plates have fused or will not be crossed, and the following adolescent distal radius fractures:
- Intra-articular fractures exiting the epiphysis
- Intra-articular fractures exiting the metaphysis
- Physeal crush injuries
- Any injuries which cause growth arrest to the distal radius.
Type of Use (Select one or both, as applicable)X 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/0 description: The image shows the logo for DePuy Synthes, a company that is part of the Johnson & Johnson family of companies. The logo features a symbol of two overlapping circles in gold, followed by the company name "DePuy Synthes" in blue. Underneath the company name, it says "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in smaller letters. To the right of the company name, the phrase "People inspired" is written in a cursive font.
510(k) Summary
Date Prepared: February 9, 2017
| Sponsor: | DePuy SynthesJoanna Rieder1301 Goshen ParkwayWest Chester, PA 19380Office: +41 32 720 41 17Fax +41 32 720 71 73 |
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| ProprietaryName: | DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long |
| Classification: | Classification: Class IIRegulation Number: 21 CRF §888.3030Product Code: HRS |
| PredicateDevice | 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES (K102694) |
| ReferencePredicate | SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM (K063049) |
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Image /page/4/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 features a gold-colored abstract symbol on the left, followed by the company name in blue. To the right of the company name, the phrase "People inspired" is written in a cursive font.
| DeviceDescription: | The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal RadiusPlate, Extra-Long will be available in stainless steel and titanium. The head ofthe plate will remain the same as the existing 2.4mm VA-LCP Two-ColumnVolar Distal Radius Plate (K102694) and will therefore allow the use of theexisting guide block for these plates. The DePuy Synthes 2.4/2.7mm VA-LCPTwo-Column Volar Distal Radius Plate, Extra-Long will come in 3 differentlengths (7 shaft holes, 10 shaft holes and 13 shaft holes). To accommodatedifferent patient anatomy, the plate with 7 shaft holes will be available withthree different plate head widths (Standard, Narrow and Wide). The 10 shafthole and the 13 shaft hole plate will only be released with the Standard platehead width and additionally they feature a curvature in the shaft. All plates willfeature left- and right-specific designs and will be offered in sterile packed only.The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal RadiusPlates, Extra-Long are designed to accept existing 2.4mm Variable AngleLocking Screws, 2.4mm Cortex Screws, 2.4mm Locking Screws, 1.8mm VAButtress Pins and 1.8mm Locking Buttress Pins in the plate head holes. In theplate shaft, existing 2.4mm Cortex Screws, 2.7mm Cortex Screws, 2.4mmVariable Angle Locking Screws, 2.7mm Variable Angle Locking Screws,2.4mm Locking Screws, and 2.7mm Locking Screws can be inserted. |
|---|---|
| Indications forUse: | The DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar Distal RadiusPlate, Extra-Long is intended for intra- and extra-articular fractures,osteotomies, nonunions and malunions of the distal radius, with or withoutextension into the radial diaphysis in adults and adolescents (12-21) where thegrowth plates have fused or will not be crossed, such as:- Intra-articular fractures exiting the epiphysis- Intra-articular fractures exiting the metaphysis- Physeal crush injuries- Any injuries which cause growth arrest to the distal radius |
| Comparison toPredicate: | The proposed DePuy Synthes 2.4/2.7mm VA-LCP Two-Column Volar DistalRadius Plate, Extra-Long has similar indications, in comparison to the predicatedevices.The features of the subject device are substantially equivalent to the predicatedevices based on the similarities in intended use and design, where the newdevice can additionally treat fractures with extension to the radial shaft.Mechanical testing demonstrates substantial equivalence of the subject deviceto the predicates devices in regards to mechanical strength. In addition theintended use, manufacturing methods, packaging, and sterilization of thepredicates compared to the subject devices are identical. The subject device andpredicate devices are made from stainless steel (316L) or commercially puretitanium (CP4) |
| SubstantialEquivalence: | Functional and mechanical testing demonstrate that the proposed DePuySynthes 2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long is comparable in mechanical and functional properties to the predicatedevices. |
| Worst case plates were tested to assess the mechanical performance of thenewly developed implants. The defined worst cases were tested under static anddynamic loading conditions and were then compared to the predicate devices: | |
| Four Point Bending Test was performed to access the mean static and medianfatigue strength for non-contoured and contoured subject plates and evaluatethe plate shaft performance. The new plates performed better than the predicatedevice. | |
| Construct (plate with screws) axial bending was performed to access the plateconstruct strength and evaluate the plate head performance. The new platesperformed better than the predicate device. | |
| Torque Through Testing was performed to assess the mechanical properties ofthe plate to screw interface. | |
| Biocompatibility testing was performed to demonstrate that the DePuy Synthes2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long isbiocompatible. | |
| LAL testing has been performed to establish that the subject device meets thespecified 20EU/device limit. | |
| Based on the aforementioned mechanical testing, the subject DePuy Synthes2.4/2.7mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long issubstantially equivalent to the predicate device. |
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Image /page/5/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 tagline "People inspired" in a handwritten-style font. The text "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" is located underneath the company name in a smaller font.
§ 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.