DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System

K260069 · Synthes GmbH · HRS · Mar 9, 2026 · Orthopedic

Device Facts

• Record ID: K260069
• Device Name: DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System
• Applicant: Synthes GmbH
• Product Code: HRS · Orthopedic
• Decision Date: Mar 9, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System is indicated for internal fixation of proximal tibia fractures in adults and adolescents (12-21 years) where growth plates have fused. VOLT Proximal Tibia Plates: Indicated for fractures of the proximal end segment of the tibia. VOLT Proximal Tibia Plates, Long: Indicated for fractures of the proximal end segment of the tibia with or without extension into the diaphysis.

Device Story

System comprises stainless steel 3.5-mm contoured plates with variable angle screw holes; intended for stabilization and internal fixation of proximal tibia fractures. Used in healthcare facilities by surgeons. Device provides mechanical support for bone healing; output is physical stabilization of fracture site. Includes non-implantable accessories: guide blocks, sizing templates, and trays. Benefits patient through rigid fixation of bone segments to facilitate healing.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance testing, including computational finite element analysis (static bending construct test) and MR compatibility testing.

Technological Characteristics

Stainless steel 3.5-mm contoured plates with variable angle screw holes. Single-use. Includes non-implantable guide blocks, sizing templates, and trays. MR Conditional. Mechanical fixation principle.

Indications for Use

Indicated for internal fixation of proximal tibia fractures in adults and adolescents (12-21 years) with fused growth plates. Includes fractures of the proximal end segment of the tibia, with or without extension into the diaphysis.

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 VOLT Small Fragment Plating System (K233665)
• Synthes LCP Proximal Tibia Plate (K011978)
• Synthes (USA) 3.5/4.5mm LCP Medial Proximal Tibia Plates (K050646)
• Synthes (USA) 3.5mm LCP Posteromedial Proximal Tibia Plates (K082624)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 9, 2026

Synthes GmbH
Enrico Gindro, PhD
Senior Regulatory Affairs Program Lead
Luzernstrasse 21
Zuchwil, SO 4528
Switzerland

Re: K260069
Trade/Device Name: DePuy Synthes VOLT™ Proximal Tibia 3.5 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: January 9, 2026
Received: January 9, 2026

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 (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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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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 13485 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 Medical Device File (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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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services [phone] EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K260069 | |
| Device Name DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System | |
| Indications for Use (Describe) The DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System is indicated for internal fixation of proximal tibia fractures in adults and adolescents (12-21 years) where growth plates have fused. VOLT Proximal Tibia Plates: Indicated for fractures of the proximal end segment of the tibia. VOLT Proximal Tibia Plates, Long: Indicated for fractures of the proximal end segment of the tibia with or without extension into the diaphysis. | |
| 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 [e-mail] | |
| "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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K260069 - Page 1 of 2

# 510(K) SUMMARY

| Sponsor | Synthes GmbH
Luzernstrasse 21
4528 Zuchwil (SO)
Switzerland |
| --- | --- |
| Contact | Enrico Gindro, PhD
Senior Regulatory Affairs Program Lead
T: [phone]
E: [e-mail] |
| Alternate Contact | Oliver Steiner, PhD
Director Regulatory Affairs
T: [phone]
E: [e-mail] |
| Date Prepared | January 09, 2026 |
| Proprietary Name | DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories;
Smooth or threaded metallic bone fixation fastener |
| Classification | Class II
Regulation Number: 21 CFR §888.3030
Product Code: HRS |
| Predicate Device | Primary predicate:
• K233665 – DePuy Synthes VOLT Small Fragment Plating System
Additional predicates:
• K011978 – Synthes LCP Proximal Tibia Plate
• K050646 – Synthes (USA) 3.5/4.5mm LCP Medial Proximal Tibia Plates
• K082624 – Synthes (USA) 3.5mm LCP Posteromedial Proximal Tibia Plates |
| Device Description | The DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System comprises implantable devices intended for the stabilization and internal fixation of proximal tibia fractures. The system offers five families of stainless steel 3.5-mm contoured plates with variable angle screw holes. Plates within the VOLT™ Proximal Tibia 3.5 Plating System are available in various lengths, sterile or non-sterile, and are single-use only. The system also includes non-implantable, dedicated guide blocks, sizing templates, and trays as accessories for use with the implants. |
| Indications for Use | The DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System is indicated for internal fixation of proximal tibia fractures in adults and adolescents (12-21 years) where growth plates have fused.
VOLT Proximal Tibia Plates:
Indicated for fractures of the proximal end segment of the tibia.
VOLT Proximal Tibia Plates, Long:
Indicated for fractures of the proximal end segment of the tibia with or without extension into the diaphysis. |
| Contraindications | No contraindications specific to these devices. |

510(k) VOLT Proximal Tibia 3.5 Plating System

510(k) Summary

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K260069 - Page 2 of 2

| 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 moment and stiffness. Additionally, Magnetic Resonance compatibility testing has been performed to establish MR Conditional parameters for the subject VOLT^{TM} Proximal Tibia 3.5 Plating System. |
| --- | --- |
| Clinical Performance Data | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial Equivalence | The subject devices share the same intended use and similar indications as the predicate devices. The subject and predicate devices are metallic orthopedic plates intended for bone fracture fixation and are similar in design and fundamental technology. Both the subject and predicate devices are made from the same material and are intended for use by surgeons in a healthcare facility.
The non-clinical performance data and analytical evaluations included in this premarket notification demonstrate that any differences in technological characteristics between the subject devices and the predicate devices do not raise 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 demonstrate the substantial equivalence of the subject devices to their predicate devices. |

510(k) VOLT Proximal Tibia 3.5 Plating System
510(k) Summary
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