Versalock Proximal Tibial Plating System
Device Facts
| Record ID | K261406 |
|---|---|
| Device Name | Versalock Proximal Tibial Plating System |
| Applicant | GM Dos Reis Industria e Comercio Ltda. |
| Product Code | HRS · Orthopedic |
| Decision Date | Jul 21, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Versalock Proximal Tibial Plating System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and nonunions in the proximal tibia.
Device Story
Versalock Proximal Tibial Plating System consists of titanium alloy locking plates and screws designed for internal bone fixation. Used by orthopedic surgeons in clinical settings for stabilization of proximal tibial fractures, fusions, osteotomies, and nonunions. System features variable fixation angle screws; plates range from 3.5 to 4.0 mm thickness; screws have 3.5 mm diameter. Surgeon selects appropriate plate/screw configuration based on patient anatomy and fracture pattern to achieve rigid fixation. Output is mechanical stabilization of bone segments, facilitating healing. Device is purely mechanical; no software or electronic components.
Clinical Evidence
Bench testing only. Mechanical testing performed according to ASTM F382 and ASTM F543; all tests met predetermined acceptance criteria. No clinical data included.
Technological Characteristics
Materials: Titanium alloy. Sensing/Actuation: None (mechanical fixation). Energy Source: None. Dimensions: Plates 3.5-4.0 mm thick; screws 3.5 mm diameter. Connectivity: None. Sterilization: Not specified. Standards: ASTM F382 (metallic bone plates), ASTM F543 (metallic bone screws).
Indications for Use
Indicated for internal bone fixation for bone fractures, fusions, osteotomies, and nonunions in the proximal tibia in adolescents (12-22 years) and adults (22+ years).
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
- Arthrex Fracture System (K112437)
- AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System (K202489)
Reference Devices
- Mini and Micro Fragments Reconstruction System - GMReis (K182718)
- Versalock Upper Limb Plating System (K243740)
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
July 21, 2026
GM Dos Reis Industria e Comercio Ltda.
Guilherme Esteves Pontes
Regulatory Affairs Specialist
Avenida Pierre Simon De Laplace, 600
Campinas, SP 13069320
Brazil
Re: K261406
Trade/Device Name: Versalock Proximal Tibial 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, HWC
Dated: April 29, 2026
Received: April 29, 2026
Dear Guilherme Esteves Pontes:
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.
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
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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), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (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 ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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
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regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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
2026.07.21 16:44:24 -04'00'
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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# 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. | | K261406 | ? |
| --- | --- | --- | --- |
| Please provide the device trade name(s). | | | ? |
| Versalock Proximal Tibial Plating System | | | |
| Please provide your Indications for Use below. | | | ? |
| The Versalock Proximal Tibial Plating System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and nonunions in the proximal tibia. | | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? |
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GMREIS
Qualidade para Vida
Premarket Notification 510(k) - FDA
# Section 5 - 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.
# I. Submitter:
GM Dos Reis Industria e Comercio Ltda
Avenida Pierre Simon de La Place 600
Campinas, São Paulo, Brazil 13069-320
Guilherme Esteves Pontes, Regulatory Affairs Specialist
Telephone: +55 (19) 3765-9900
Email: qualidade4@gmreis.com.br
Date prepared: April 29, 2026
# II. Device Name:
Trade Name: Versalock Proximal Tibial Plating System
Common Name: Plate, fixation, bone / Screw, fixation, bone
Classification Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories / Smooth or threaded metallic bone fixation fastener
Device Class: II
Product Codes: HRS/HWC
Regulation Number: 21 CFR 888.3030/888.3040
# III. Predicate Devices:
Legally marketed device to which we are claiming “Substantial Equivalence” are the following:
Arthrex Fracture System (K112437) (Primary Predicate Device)
Mini and Micro Fragments Reconstruction System - GMReis (K182718) (Reference Device)
AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System (K202489) (Additional
Predicate Device)
Versalock Upper Limb Plating System (K243740) (Reference Device)
GM dos Reis Industria e Comercio Ltda.
Pierre Simon de Laplace Ave., 600, Block 3F9677
Techno Park, Campinas, SP, Brazil, Zip Code 13069320
Phone: +551937659900, Email: gmreis@gmreis.com.br
Website: www.gmreis.com.br
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GMREIS
Qualidade para Vida
Premarket Notification 510(k) - FDA
# IV. Device Description:
The Versalock Proximal Tibial Plating System is a system composed of locking plates and screws with variable fixation angle for the synthesis of the tibial bones. The bone plates and screws are made from titanium alloy. The plates range in thickness from 3.5 to 4.0 mm, and the screws have the diameter of 3.5 mm.
# V. Statement of Indications for Use of the Device:
The Versalock Proximal Tibial Plating System is intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and nonunions in the proximal tibia.
# VI. Comparison of Technological Characteristics with The Predicate Device:
The subject device is substantially equivalent in indications and design principles to the following predicate device:
K112437 - Arthrex Fracture System - Arthrex
The subject and predicate device have equivalent intended use and equivalent technological characteristics. Both devices are manufactured from identical materials and share equivalent design characteristics as well as physical dimensions. Any difference in technological characteristics do not raise new issues of safety or efficacy. The performance of the subject device was demonstrated through mechanical testing according to standards and predicate comparison. No clinical data were included in this submission.
# VII. Performance Data:
Mechanical testing was performed according to ASTM F382 and ASTM F543 and all tests confirmed that the product met the predetermined acceptance criteria.
# VIII. Conclusions:
As was established in this submission, the subject Versalock Proximal Tibial Plating System are equivalent to the predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to have the same technological characteristics, intended use, indications for use, material composition, anatomical region, multiple sizes, and basic design features compared to its predicate devices. Any differences between the subject and the predicate devices are considered minor and do not raise different questions of safety or effectiveness. Based on the information provided, GMReis has determined that the proposed device is substantially equivalent to the predicate device.
GM dos Reis Industria e Comercio Ltda.
Pierre Simon de Laplace Ave., 600, Block 3F9677
Techno Park, Campinas, SP, Brazil, Zip Code 13069320
Phone: +551937659900, Email: gmreis@gmreis.com.br
Website: www.gmreis.com.br
