The DePuy Synthes 2.7mm VA LCP Clavicle Plate System is indicated for fixation of fractures, and nonunions of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

Device Description

The DePuy Synthes 2.7mm VA LCP Clavicle Plate System consists of lateral, shaft and medial plates designed for temporary fixation, correction or stabilization of clavicle bones. The subject plates are available in various sizes in both sterile and non-sterile configurations and are available in stainless steel and titanium alloy. The system also consists of non-implantable templates that correspond to the implants. Templates are intended for implant size selection and are available in non-sterile.

The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System consists of the plate types Long, Short and Button which can be used to treat simple and complex clavicle fractures including malunions, non- unions and isolated ligamentous injuries of the AC joint. The subject plates are available in three hook depths, in left- and right-side versions, in both sterile and non-sterile configurations and are available in stainless steel and titanium. The system also consists of non- implantable templates that correspond to the implants. Templates are intended for implant size selection and are available non-sterile.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for two medical devices: the DePuy Synthes 2.7mm VA LCP Clavicle Plate System and the DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive studies in the way a novel device might.

Therefore, the document explicitly states that "Non-clinical performance data was not necessary for the determination of substantial equivalence" and "Clinical testing was not necessary for the determination of substantial equivalence". This means there are no acceptance criteria, device performance data, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance studies described in this document.

The basis for clearance is that the subject devices (DePuy Synthes 2.7mm VA LCP Clavicle Plate System and DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System) are substantially equivalent to previously cleared predicate devices (K201321 and K201959, respectively). The manufacturer asserts that the design, features, and specifications (technological characteristics) of the subject devices remain unchanged compared to their respective predicate devices. Any differences (e.g., additional contraindications or sterile/non-sterile options for the hook plate system) are argued not to raise new questions of safety and effectiveness.

In summary, this document does not contain the information requested about acceptance criteria and a study proving device performance because such studies were deemed unnecessary for a 510(k) submission based on substantial equivalence.

Summary

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December 16, 2020

DePuy Synthes % Georgina Mueller Regulatory Affairs Specialist II Synthes GmbH Luzernstrasse 21 Zuchwil. SO 4528 Switzerland

Re: K203414

Trade/Device Name: DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate 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: November 16, 2020 Received: November 19, 2020

Dear Georgina Mueller:

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.

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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 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,

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203414

Device Name

DePuy Synthes 2.7mm VA LCP Clavicle Plate System

Indications for Use (Describe)

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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Indications for Use

510(k) Number (if known) K203414

Device Name

DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System

Indications for Use (Describe)

The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

Type of Use (Select one or both, as applicable)

ü Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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| X 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.

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."

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510(k) Summary

DePuy Synthes 2.7mm VA LCP Clavicle Plate System

Sponsor	DePuy SynthesGeorgina Mueller1301 Goshen ParkwayWest Chester, PA 19380Phone: +41 61 965 63 14
Date Prepared	November 16, 2020
Proprietary Name	DePuy Synthes 2.7mm VA LCP Clavicle Plate System
Classification Name	Single/multiple component metallic bone fixation appliances andaccessories
Classification	Class IIRegulation Number: 21 CFR 888.3030Product Code: HRS
Predicate device	DePuy Synthes 2.7mm VA LCP Clavicle Plate System (K201321)
Device Description	The DePuy Synthes 2.7mm VA LCP Clavicle Plate System consists oflateral, shaft and medial plates designed for temporary fixation,correction or stabilization of clavicle bones. The subject plates areavailable in various sizes in both sterile and non-sterile configurationsand are available in stainless steel and titanium alloy. The system alsoconsists of non-implantable templates that correspond to the implants.Templates are intended for implant size selection and are available innon-sterile.
Indications for use	Fixation of fractures, osteotomies, and non-unions of the clavicle inadults, and in both adolescents (12-18 years) and transitionaladolescents (18-21 years), in which the clavicular growth plates havefused or in which the growth plates will not be crossed by the platesystem.
Technological Characteristics	The design, features, and specifications of the subject device remainunchanged compared to the previously cleared version of this devicecleared via K201321 (predicate device).
Non-clinical PerformanceData	Non-clinical performance data was not necessary for the determinationof substantial equivalence.
Clinical Performance Data	Clinical testing was not necessary for the determination of substantialequivalence.
Substantial Equivalence	The following subject device characteristics remain unchangedcompared to the previously cleared version of these devices(predicate):- Intended for the use in temporary fixation, correction or stabilizationof clavicle bones during open reduction internal fixation (ORIF)performed by surgeons within a health care facility. Plates areavailable sterile and non-sterile. Sterile plates are sterilized bygamma irradiation.- Indicated for fixation of fractures, osteotomies, and non-unions ofthe clavicle in adults, and in both adolescents (12-18 years) andtransitional adolescents (18-21 years), in which the claviculargrowth plates have fused or in which the growth plates will not becrossed by the plate system.- Design, features, and specifications (technological characteristics)The subject devices have added contraindications compared to thepredicate devices which has no contraindications. The differences incontraindications of the subject devices compared to the predicatedevices do not raise any new questions of safety and effectiveness.It is concluded that the information provided herein supports substantialequivalence of the subject devices.

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DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System

Sponsor	DePuy SynthesGeorgina Mueller1301 Goshen ParkwayWest Chester, PA 19380Phone: +41 61 965 63 14
Date Prepared	November 16, 2020
Proprietary Name	DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
Classification Name	Single/multiple component metallic bone fixation appliances andaccessories
Classification	Class IIRegulation Number: 21 CFR 888.3030Product Code: HRS
Predicate device	DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System (K201959)
Device Description	The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate Systemconsists of the plate types Long, Short and Button which can be used
	to treat simple and complex clavicle fractures including malunions, non- unions and isolated ligamentous injuries of the AC joint. The subject plates are available in three hook depths, in left- and right-side versions, in both sterile and non-sterile configurations and are available in stainless steel and titanium. The system also consists of non- implantable templates that correspond to the implants. Templates are intended for implant size selection and are available non-sterile.
Indications for use	The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
Technological Characteristics	The design, features, and specifications of the subject device remain unchanged compared to the previously cleared version of this device cleared via K201959 (predicate device).
Non-clinical PerformanceData	Non-clinical performance data was not necessary for the determination of substantial equivalence.
Clinical Performance Data	Clinical testing was not necessary for the determination of substantial equivalence.
Substantial Equivalence	The following subject device characteristics remain unchanged compared to the previously cleared version of these devices (predicate): Intended for the use in fixation of the clavicle and the acromioclavicular joint during open reduction internal fixation (ORIF) performed by surgeons within a health care facility. Subject plates are available sterile and nonsterile, whereas the predicate plates are available sterile only. Sterile plates are sterilized by gamma irradiation. Indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. Design, features, and specifications (technological characteristics) The subject devices have revised contraindications compared to the compared to the predicate device. The differences in contraindications of the subject devices compared to the predicate devices 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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Regulation Number and Section

§ 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.