DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System

K254093 · Synthes GmbH · Mar 10, 2026 · OR

Device Facts

• Record ID: K254093
• Device Name: DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System
• Applicant: Synthes GmbH
• Decision Date: Mar 10, 2026
• Decision: SESE
• Submission Type: Traditional
• Attributes: Therapeutic

Intended Use

The VOLT™ Medial Distal Femur 3.5 Plating System is indicated for internal fixation of isolated medial condylar fractures as a standalone fixation device. For all other distal femur fractures, corrective osteotomies, non-unions, or malunions, it is indicated for use as an adjunct to primary fixation. The VOLT™ Medial Distal Femur 3.5 Plating System is intended for adults and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.

Device Story

System consists of stainless steel anatomic plates with variable angle screw holes; used for internal bone fixation in distal femur. Plates accept 3.5mm locking, 3.5mm cortical, and 4.0mm cancellous screws. Operated by orthopedic surgeons in clinical/surgical settings. Provides mechanical stabilization of fractures, osteotomies, or non-unions to facilitate bone healing. Device is single-use and supplied sterile.

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 anatomic plates with variable angle screw holes; compatible with 3.5mm locking, 3.5mm cortical, and 4.0mm cancellous screws. MR Conditional. Sterile, single-use.

Indications for Use

Indicated for adults and adolescents (12-21 years) with fused growth plates or unfused plates not compromised by fixation; used for internal fixation of isolated medial condylar fractures (standalone) or as adjunct for other distal femur fractures, corrective osteotomies, non-unions, or malunions.

Predicate Devices

• DePuy Synthes VOLT Small Fragment Plating System (K233665)
• Synthes (USA) 3.5 and 4.5 mm Locking Compression Plate System with Expanded Indications (K082807)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 10, 2026

Synthes GmbH
Gengqiao Peng
Senior Regulatory Affairs Specialist
Luzernstrasse 21
Zuchwil, SO 4528
Switzerland

Re: K254093
Trade/Device Name: DePuy Synthes VOLT™ Medial Distal Femur 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: December 19, 2025
Received: December 19, 2025

Dear Gengqiao Peng:

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) K254093 | |
| Device Name DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System | |
| Indications for Use (Describe) The VOLT™ Medial Distal Femur 3.5 Plating System is indicated for internal fixation of isolated medial condylar fractures as a standalone fixation device. For all other distal femur fractures, corrective osteotomies, non-unions, or malunions, it is indicated for use as an adjunct to primary fixation. The VOLT™ Medial Distal Femur 3.5 Plating System is intended for adults and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation. | |
| 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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K254093 - Page 1 of 2

510(K) SUMMARY

| Sponsor | Synthes GmbH,
Luzernstrasse 21
4528 Zuchwil,
Switzerland |
| --- | --- |
| Contact | Gengqiao Peng
Senior Regulatory Affairs Specialist
T: [phone]
E: [e-mail] |
| Alternate Contact | Joanna Buttler
Manager Regulatory Affairs
T: [phone]
E: [e-mail] |
| Date Prepared | December 16, 2025 |
| Proprietary Name | DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification | Class II
Regulation Numbers: 21 CFR
§888.3030 Product Codes: HRS |
| Predicate Device | Primary Predicate Device:
• K233665 - DePuy Synthes VOLT Small Fragment Plating System

Additional Predicate Device:
• K082807 – Synthes (USA) 3.5 and 4.5 mm Locking Compression Plate System with Expanded Indications |
| Device Description | The DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System is a family of implantable devices consisting of 3.5mm anatomic Medial Distal Femur plates with variable angle screw holes. These plates are available in Stainless Steel, supplied sterile, and intended for single use only. These plates accept VOLT™ Stainless Steel screws, including VOLT™ 3.5 mm locking, 3.5 mm cortical, and 4.0 mm cancellous screws. |

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| Indications for Use | The VOLT™ Medial Distal Femur 3.5 Plating System is indicated for internal fixation of isolated medial condylar fractures as a standalone fixation device. For all other distal femur fractures, corrective osteotomies, non-unions, or malunions, it is indicated for use as an adjunct to primary fixation.

The VOLT™ Medial Distal Femur 3.5 Plating System is intended for adults and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation. |
| --- | --- |
| 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 yield load.
• Magnetic Resonance compatibility testing has been performed to establish MR Conditional parameters for the subject VOLT™ Medial Distal Femur 3.5 Plating System. |
| Clinical Performance Data | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial Equivalence | The subject devices have the same 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. |

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