Versalock Sterile Plating System

K262537 · GM Dos Reis Industria e Comercio Ltda. · HRS · Aug 19, 2026 · Orthopedic

Device Facts

• Record ID: K262537
• Device Name: Versalock Sterile Plating System
• Applicant: GM Dos Reis Industria e Comercio Ltda.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 19, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Versalock Sterile Plating System is intended for fracture fixation, arthrodesis, reconstruction, osteotomy fixation and non-unions of the hand, wrist, forearm, clavicle, scapula, olecranon, humerus, proximal tibia, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Device Story

Versalock Sterile Plating System consists of metallic bone plates and screws; used for fracture fixation, arthrodesis, reconstruction, osteotomy, and non-unions in various anatomical regions (hand, wrist, forearm, clavicle, scapula, olecranon, humerus, proximal tibia, foot, ankle). Implants provide mechanical stabilization of bone segments; locking mechanism beneficial for osteopenic bone. Used in clinical/surgical settings by orthopedic surgeons. System provided sterile by ethylene oxide (EO) to facilitate surgical workflow. Output is physical stabilization of bone; clinical decision-making based on surgeon assessment of fracture/reconstruction needs. Benefits include restoration of skeletal alignment and support for bone healing.

Clinical Evidence

No clinical data included. Performance demonstrated through mechanical testing according to standards and predicate comparison.

Technological Characteristics

Materials: Titanium alloy (ASTM F136) and pure titanium (ASTM F67). Plate thickness: 0.6-4.0 mm. Screw diameter: 1.3-3.5 mm. Sterilization: Ethylene oxide (EO). Design: Locking plate/screw system for bone fixation.

Indications for Use

Indicated for adults requiring fracture fixation, arthrodesis, reconstruction, osteotomy fixation, or non-union treatment in the hand, wrist, forearm, clavicle, scapula, olecranon, humerus, proximal tibia, foot, and ankle; includes treatment of fractures in osteopenic bone.

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

• Super Upper Limbs Versalock Plating System (K260390)
• Versalock Mini and Micro Plating System (K242596)
• GMReis Ankle Plating System (K242998)
• Versalock Upper Limb Plating System (K243740)
• Mini and Micro Fragments Reconstruction System – GMReis (K182718)
• Versalock Proximal Tibial Plating System (K261406)

Submission Summary (Full Text)

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**FDA** U.S. FOOD & DRUG
ADMINISTRATION

August 19, 2026

GM Dos Reis Industria e Comercio Ltda.
Guilherme Esteves Pontes
Regulatory Affairs Specialist
Avenida Pierre Simon De La Pl., 600
Campinas, SP 13069320
Brazil

Re: K262537

Trade/Device Name: Versalock Sterile 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: July 22, 2026

Received: July 23, 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.

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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K262537 - Guilherme Esteves Pontes

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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), 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 regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K262537 - Guilherme Esteves Pontes

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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, 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. | K262537 | ? |
| Please provide the device trade name(s). | | ? |
| Versalock Sterile Plating System | | |
| Please provide your Indications for Use below. | | ? |
| The Versalock Sterile Plating System is intended for fracture fixation, arthrodesis, reconstruction, osteotomy fixation and non-unions of the hand, wrist, forearm, clavicle, scapula, olecranon, humerus, proximal tibia, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. | | |
| Please select the types of uses. | ☑ 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 | K262537 |
| --- | --- | --- |
| | | Page 1 of 3 |

### 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: [phone]

Email: [e-mail]

Date prepared: July 22, 2026

### II. Device Name:

Trade Name: Versalock Sterile 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 / 21 CFR 888.3040

### III. Predicate Devices:

Legally marketed device to which we are claiming “Substantial Equivalence” are the following:

K260390 - Super Upper Limbs Versalock Plating System (Primary Predicate Device)

K242596 - Versalock Mini and Micro Plating System (Additional Predicate Device)

K242998 - GMReis Ankle Plating System (Additional Predicate Device)

K243740 - Versalock Upper Limb Plating System (Additional Predicate Device)

K182718 - Mini and Micro Fragments Reconstruction System – GMReis (Additional Predicate Device)

K261406 - Versalock Proximal Tibial Plating System (Additional 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: [phone], Email: [e-mail]

Website: www.gmreis.com.br

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| GMREIS Qualidade para Vida | Premarket Notification 510(k) - FDA | K26XXXX |
| --- | --- | --- |
| | | Page 2 of 3 |

#### IV. Device Description:

The Versalock Sterile Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates and screws are made from commercial titanium alloy and pure titanium. The plates range in thickness from 0.6 to 4.0 mm, and the screws range in diameter from 1.3 to 3.5 mm.

Versalock Plating System implants are manufactured with the following raw materials:

- Titanium Alloy Ti6Al4V according to ASTM F136
- Pure Titanium according to ASTM F67

#### V. Reason for 510(k) submission:

This Special 510(k) premarket notification is submitted to obtain clearance for the Versalock Sterile Plating System as an option sterile by EO to the plates and screws cleared under K260390, K242596, K242998, K243740, K182718 and K261406.

#### VI. Statement of Indications for Use of the Device:

The Versalock Sterile Plating System is intended for fracture fixation, arthrodesis, reconstruction, osteotomy fixation and non-unions of the hand, wrist, forearm, clavicle, scapula, olecranon, humerus, proximal tibia, foot and ankle. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

#### VII. Comparison of Technological Characteristics with The Predicate Devices:

The subject device is substantially equivalent in indications and design principles to the following predicate devices:

K260390 - Super Upper Limbs Versalock Plating System

K242596 - Versalock Mini and Micro Plating System

K242998 - GMReis Ankle Plating System

K243740 - Versalock Upper Limb Plating System

K182718 - Mini and Micro Fragments Reconstruction System – GMReis

K261406 - Versalock Proximal Tibial Plating System

The subject and predicate device have the same intended use and the same 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.

GM dos Reis Industria e Comercio Ltda.

Pierre Simon de Laplace Ave., 600, Block 3F9677

Techno Park, Campinas, SP, Brazil, Zip Code 13069320

Phone: [phone], Email: [e-mail]

Website: www.gmreis.com.br

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|  GMREISQualidade para Vida | Premarket Notification 510(k) - FDA | K26XXXX |
| --- | --- | --- |
| | | Page 3 of 3 |

### VIII. Performance Data:

The subject device components possess the same technological characteristics as the predicate devices.

### IX. Conclusions:

As was established in this submission, the subject Versalock Sterile 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: [phone], Email: [e-mail]

Website: www.gmreis.com.br