The VOLT™ Ankle Trauma 2.7/3.5 Plating System is intended for internal fixation/stabilization of bone fragments of distal tibia & distal fibula for adults and adolescents (12-21 years) where growth plates have fused.

VOLT™ Calcaneus 2.7 Plating System

The VOLT™ Calcaneus 2.7 Plating System is indicated for fractures, non-unions and deformity corrections in the calcaneus

The VOLT™ Calcaneus 2.7 Plating System is intended for internal fixation/stabilization of bone fragments of distal tibia & distal fibula for adults and adolescents (12-21 years) where growth plates have fused.

Device Description

VOLT™ Ankle Trauma 2.7/3.5 Plating System

The VOLT™ Ankle Trauma 2.7/3.5 Plating System is a family of implantable devices consisting of 2.7mm, 2.7mm/3.5mm and 3.5 mm anatomic and non-anatomic plates with variable angle screw holes. The plates of this system are available in Stainless Steel. Plates within the VOLT™ Ankle Trauma 2.7/3.5 Plating System are available non-sterile and are single-use only.

VOLT™ Calcaneus 2.7 Plating System

The VOLT™ Calcaneus 2.7 Plating System is a family of implantable devices consisting of 2.7mm anatomic plates with variable angle screw holes. The plates of this system are available in Stainless Steel. Plates within the VOLT™ Calcaneus 2.7 Plating System are available non-sterile and are single-use only.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - VOLT™ Ankle Trauma and Calcaneus Plating Systems

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March 2, 2026

Synthes GmbH
Brendan Daly
Senior Regulatory Affairs Program Lead
Luzernstrasse 21
Zuchwil, SO 4528
Switzerland

Re: K254054
Trade/Device Name: VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 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: December 15, 2025
Received: December 17, 2025

Dear Mr. Daly:

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 (the 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 available 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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K254054 - Brendan Daly
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K254054 - Brendan Daly
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assistance/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,

CHRISTOPHER FERREIRA -S

Christopher Ferreira, M.S.
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

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K254054

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.	K254054

Please provide the device trade name(s).

VOLT™ Ankle Trauma 2.7/3.5 Plating System;
VOLT™ Calcaneus 2.7 Plating System

Please provide your Indications for Use below.

VOLT™ Ankle Trauma 2.7/3.5 Plating System

The VOLT™ Ankle Trauma 2.7/3.5 Plating System is indicated for fractures, non-unions and deformity corrections in the distal tibia and distal fibula.

VOLT™ Calcaneus 2.7 Plating System

The VOLT™ Calcaneus 2.7 Plating System is indicated for fractures, non-unions and deformity corrections in the calcaneus

Please select the types of uses (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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510(K) SUMMARY OF THE VOLT™ Ankle Trauma 2.7/3.5 Plating System & VOLT™ Calcaneus 2.7 Plating System

Sponsor	Synthes GmbH, Luzernstrasse 21, 4528 Zuchwil, Switzerland.
Contact	Brendan Daly, PhDSenior Regulatory Affairs Program LeadT: +41 76 516 35 26E: bdaly3@its.jnj.com
Alternate Contact	Oliver Steiner, PhDDirector Regulatory AffairsT: +41 79 229 31 83E: osteiner@its.jnj.com
Date Prepared	December 15, 2025
Proprietary Name	VOLT™ Ankle Trauma 2.7/3.5 Plating SystemVOLT™ Calcaneus 2.7 Plating System
Classification Name	Single component metallic bone fixation appliances and accessories
Classification	Class IIRegulation Numbers: 21 CFR §888.3030Product Codes: HRS
Predicate Device	All predicates are considered as primary predicates as this is a bundled traditional 510(k) submission.Primary Predicate Devices:• K011335 - Synthes One-Third Tubular DCL Plate• K991407 - Synthes Locking Calcaneal Plates• K063049 - Synthes (USA) Modular Mini Fragment LCP System• K211051 - DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates
Device Description	VOLT™ Ankle Trauma 2.7/3.5 Plating SystemThe VOLT™ Ankle Trauma 2.7/3.5 Plating System is a family of implantable devices consisting of 2.7mm, 2.7mm/3.5mm and 3.5 mm anatomic and non-anatomic plates with variable angle screw holes. The plates of this system are available in Stainless Steel. Plates within the VOLT™ Ankle Trauma 2.7/3.5 Plating System are available non-sterile and are single-use only.VOLT™ Calcaneus 2.7 Plating SystemThe VOLT™ Calcaneus 2.7 Plating System is a family of implantable devices consisting of 2.7mm anatomic plates with variable angle screw holes. The

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	plates of this system are available in Stainless Steel. Plates within the VOLT™ Calcaneus 2.7 Plating System are available non-sterile and are single-use only.
Indications for Use	VOLT™ Ankle Trauma 2.7/3.5 Plating SystemThe VOLT™ Ankle Trauma 2.7/3.5 Plating System is indicated for fractures, non-unions and deformity corrections in the distal tibia and distal fibula.The VOLT™ Ankle Trauma 2.7/3.5 Plating System is intended for internal fixation/stabilization of bone fragments of distal tibia & distal fibula for adults and adolescents (12-21 years) where growth plates have fused.VOLT™ Calcaneus 2.7 Plating SystemThe VOLT™ Calcaneus 2.7 Plating System is indicated for fractures, non-unions and deformity corrections in the calcaneusThe VOLT™ Calcaneus 2.7 Plating System is intended for internal fixation/stabilization of bone fragments of distal tibia & distal fibula for adults and adolescents (12-21 years) where growth plates have fused.
Contraindications	No contraindications specific to these devices.
Non-Clinical Performance Testing	To demonstrate the safety and efficacy of the subject devices and support the substantial equivalence to their predicates, the following testing was performed:• Computational Finite Element Analysis simulating a mechanical static bending construct test, demonstrated subject plates were non-inferior regarding their bending strength.• Magnetic Resonance compatibility testing has been performed to establish MR Conditional parameters for the subject VOLT™ Ankle Trauma 2.7/3.5 Plating System & VOLT™ Calcaneus 2.7 Plating System.• Biocompatibility testing including Cytotoxicity, Sensitization, Irritation, Acute Systemic & Pyrogenicity, Subacute/Subchronic, Genotoxicity, Implantation, Chronic & Carcinogenicity Testing• Reprocessing (disinfection, cleaning and resterilization) of Non-Sterile devices
Summary of Technological Characteristics	The subject devices are an iteration on prior DePuy Synthes plating systems. Hence, the subject devices have the same technological characteristics in terms of design, material, and fundamental technology as that of the predicate devices.

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	The plates are offered in similar shapes, number of holes, accepted screw sizes, and are in the same materials as that of the predicate devices.However, there are some differences:1. Dimensions: • The different dimensions allow more targeted screw placement and is expected to be a more stable construct than their predicate devices.2. 2.7 / 3.5mm VOLT™ Locking Hole: • The locking hole technology present on the VOLT™ plates is the VOLT™ Locking Hole.
Clinical Performance Data	Clinical testing was not necessary for the determination of substantial equivalence.
Substantial Equivalence	The subject devices have a similar intended use and similar indications as their predicate devices. Additionally, the subject devices are an iteration on prior DePuy Synthes plating systems and are therefore similar in terms of design, material, and fundamental technology.The non-clinical performance data and analytic evaluations 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. The proposed devices are at least as safe and effective as the predicate devices.
Conclusion	It is concluded that the information provided demonstrates the substantial equivalence of the subject devices to their predicate devices.

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.