Who is the manufacturer of DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System?

DePuy Synthes filed the 510(k) submission for DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System (K201959).

What is the FDA product code for DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate 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 2.7mm VA LCP Clavicle Hook Plate System?

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

What are the predicate devices for DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System?

Synthes 3.5mm LCP Clavicle Hook Plates (K061753).

Who can help prepare an FDA 510(k) submission like DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate 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 2.7mm VA LCP Clavicle Hook Plate System

K201959 · DePuy Synthes · HRS · Sep 11, 2020 · Orthopedic

Device Facts

Record ID	K201959
Device Name	DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
Applicant	DePuy Synthes
Product Code	HRS · Orthopedic
Decision Date	Sep 11, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is a metallic bone fixation device used for lateral clavicle fractures and acromioclavicular joint dislocations. The system comprises plates (long, short, button configurations) available in stainless steel or titanium, along with non-implantable templates for size selection. Surgeons perform open reduction internal fixation (ORIF) in a healthcare facility, using the plates to stabilize bone segments. The plates feature Variable Angle (VA) Locking and Compression (LCP) technology, allowing screw insertion at up to 15° angulation for angular stable fixation. The device includes suture/K-wire holes and bending notches (long plates) to facilitate intra-operative contouring. By providing rigid fixation, the system supports bone healing and joint stability, benefiting patients by restoring anatomical alignment and function.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including mechanical performance testing of constructs, MR compatibility assessment, endotoxin testing (LAL method, 20EU/device), and biocompatibility evaluation per ISO 10993-1.

Technological Characteristics

Materials: 316L stainless steel and commercially pure titanium. Design: Pre-contoured plates with tapered tips and rounded shaft-profile. Features: VA LCP technology (15° angulation), Combi holes, suture/K-wire holes, bending notches. Sterilization: Gamma irradiation for sterile configurations. Connectivity: None (mechanical implant).

Indications for Use

Indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint in patients requiring open reduction internal fixation.

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

Synthes 3.5mm LCP Clavicle Hook Plates (K061753)

Related Devices

K061753 — SYNTHES (USA) CLAVICLE HOOK PLATES · Synthes (Usa) · Aug 4, 2006
K201321 — DePuy Synthes 2.7mm VA LCP Clavicle Plate System · DePuy Synthes · Jul 24, 2020
K031677 — SYNTHES (USA) CALVICLE HOOK PLATE · Synthes (Usa) · Aug 21, 2003
K101536 — 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM · Synthes (Usa), LLC · Sep 15, 2010
K140259 — VARIAX CLAVICLE HOOK PLATE · Stryker Trauma AG · Apr 1, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ September 11, 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 and Human Services logo. To the right of that is the FDA logo, which is 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. DePuy Synthes % Georgina Mueller Regulatory Affairs Specialist II Synthes GmbH Luzernstrasse 21 Zuchwil. SO 4528 Switzerland Re: K201959 Trade/Device Name: 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: July 7, 2020 Received: July 14, 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. 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 {1}------------------------------------------------ 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, for - Shumaya Ali, M.P.H. 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) ### K201959 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) > 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 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." FORM FDA 3881 (7/17) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ # 5 510(k) Summary | Sponsor | DePuy Synthes Georgina Mueller 1301 Goshen Parkway West Chester, PA 19380 Phone: +41 61 965 63 14 | | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared | September 3, 2020 | | | Proprietary Name | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | | | Classification Name | Single/multiple component metallic bone fixation appliances and accessories | | | Classification | Class II Regulation Number: 21 CFR 888.3030 Product Code: HRS | | | Predicate device | Synthes 3.5mm LCP Clavicle Hook Plates (Synthes USA Clavicle Hook Plate; K061753) | | | Device Description | 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. | | | 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 and predicate devices are compared below. The range of plate lengths, thickness and hook depths of the subject devices are similar to those offered in the predicate devices. The subject plate hooks are angulated, whereas the predicate plate hooks are not. The materials of both the subject and predicate devices are the same with plates offered in stainless steel and titanium (i.e. 316L and commercially pure titanium). The subject and predicate plates have varying screw holes; in number, type and diameter. Subject and predicate plates feature Locking and Compression Technology (LCP) and subject plates additionally feature Variable Angle (VA) technology to allow insertion of screws up to 15° angulation in addition to nominal angulation, whereas the predicate plates feature Locking Technology (LCP) only at nominal angulation. The subject plates have Variable Angle locking and Combi holes whereas the predicate plates have Locking holes and Combi holes. The subject plate screw holes are 2.7mm diameter whereas the predicate plate screw holes are 3.5mm diameter. All plates are compatible with Cortex Screws to ensure axial and plate-to-bone compression and with screws using locking technology to ensure angular stable fixation. Additional compatible screw types vary for subject (VA Locking, Metaphyseal) and predicate (Locking, Cancellous) plates, as do the screw diameters for subject plates (2.7mm) and predicate plates (3.5mm and 4.0mm). | | | | | Subject plates feature Suture / K-wire holes, whereas these are not featured in the • predicate plates. | | | | Both subject and predicate plates are pre-contoured to accommodate for anatomical differences, are available as mirrored plates dedicated for the left and right clavicle and are designed to allow intra-operative contouring. | | | | Plates have a rounded shaft-profile to reduce prominence and feature tapered tips • (edges) to facilitate plate insertion. Subject plates (long version only) feature notches to facilitate plate bending, whereas the predicate plates do not feature notches. | | Non-clinical Performance Data | | Mechanical performance testing of constructs has been performed to compare the subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates to the predicate DePuy Synthes 3.5mm LCP Clavicle Hook Plates. This data supports that the mechanical performance of the subject devices is at least equivalent to that of the predicate devices. | | | | A magnetic resonance compatibility assessment has been performed to establish MR Conditional parameters for the subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates. | | | | Endotoxin testing has been performed according to the LAL test method to establish that the sterile subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates meet the specified endotoxin requirement of 20EU/device. | | | | Biocompatibility evaluation and testing has been performed in accordance with ISO 10993-1 and it is concluded that the subject DePuy Synthes 2.7mm VA LCP Clavicle Hook Plates are biologically safe when used as intended. | | Clinical Performance Data | | Clinical testing was not necessary for the determination of substantial equivalence. | | Substantial Equivalence | | Both the subject and the predicate devices are intended for 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 for both subject and predicate are sterilized by gamma irradiation. | | | | The subject devices have the same indications as the predicate 3.5mm LCP Clavicle Hook Plates (K061753). | | | | 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 devices compared to the predicate devices do not raise any new issues of safety and effectiveness. | | | | It is concluded that the information provided herein supports substantial equivalence of the subject devices. | {4}------------------------------------------------