(83 days)
Not Found
No
The 510(k) summary describes a standard bone plating system and does not mention any AI or ML components or capabilities. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is described as "Versalock Mini and Micro Plating System is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and foot," which indicates a medical purpose to treat or alleviate a disease or injury.
No.
The device is a plating system intended for fracture fixation and other orthopedic procedures, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical plates and screws made of titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and foot." This describes a surgical implant used directly on the patient's body to treat a physical condition.
- Device Description: The description details plates and screws made of titanium, designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status. IVDs are used for diagnosis, monitoring, or screening based on analysis of biological samples.
This device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
Versalock Mini and Micro Plating System is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and foot. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
Versalock Mini and Micro 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 are made from commercially pure titanium allov and the bone screws are manufactured from titanium alloy only. The plates range in thickness from 0.6 to 1.7 mm, and the screws range in diameter from 1.3 to 2.7 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture.
Versalock Mini and Micro Plating System are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the subject devices are demonstrated through mechanical testing of plates and screws according to ASTM F382, ASTM F3437 and ASTM F543, respectively. Based on submitted testing data, the subject device is equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 21, 2024
GM Dos Reis Industria e Comercio Ltda Guilherme Esteves Pontes Regulatory Affairs Analyst Avenida Pierre Simon de La Place, 600 Campinas, SP 13069320 Brazil
Re: K242596
Trade/Device Name: Versalock Mini and Micro 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: September 17, 2024 Received: September 17, 2024
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.
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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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, MS 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
Submission Number (if known)
Device Name
Versalock Mini and Micro Plating System
Indications for Use (Describe)
Versalock Mini and Micro Plating System is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and foot. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.
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)
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Image /page/4/Picture/1 description: The image shows the logo for GMREIS. The logo consists of a circular graphic on the left, with the letters "GMREIS" in a bold, sans-serif font to the right. Below the letters, there is a tagline that reads "Qualidade para Vida". The circular graphic is divided into two sections, with the top section being red and the bottom section being blue.
Premarket Notification 510(k) - FDA
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.
l. 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 Analyst Phone: +55 (19) 3765-9900 Email: qualidade4@gmreis.com.br Date prepared: August 30, 2024
II. Device Name:
Trade Name: | Versalock Mini and Micro Plating System |
---|---|
Common Name: | Plate, fixation, bone; Screw, fixation, bone |
Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances and Accessories |
Device Class: | II |
Product Codes: | HRS; HWC |
Regulation Number: | 21 CFR 888.3030; 21 CFR 888.3040 |
III. Predicate Devices:
Legally marketed devices to which we are claiming "Substantial Equivalence" are the following: Mini and Micro Fragments Reconstruction System - GMReis (K182718) (Primary predicate device); Mini and Micro Fragments Reconstruction System - Neofix (K142419) (Additional predicate device);
IV. Device Description:
Versalock Mini and Micro 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 are made from commercially pure titanium allov and the bone screws are manufactured from titanium alloy only. The plates range in thickness from 0.6 to 1.7 mm, and the screws
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Image /page/5/Picture/1 description: The image contains the logo for "GMREIS Qualidade para Vida". The logo consists of a circular graphic on the left, with a blue lower portion and a red upper portion. To the right of the graphic is the text "GMREIS" in a bold, blue font. Below "GMREIS" is the text "Qualidade para Vida" in a smaller, lighter blue font.
Premarket Notification 510(k) - FDA
range in diameter from 1.3 to 2.7 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture.
Versalock Mini and Micro Plating System are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.
V. Statement of Indications for Use of the Device:
Versalock Mini and Micro Plating System is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and foot. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.
VI. Comparison of Technological Characteristics with The Predicate Device:
The subject and predicate devices have the same basic design and intended use. Differences between them include additional models and indication. Both are packed using the same materials and are to be sterilized by the same methods. All of the subject device final finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared predicate devices in K182718, and therefore are substantially equivalent to the predicates with regard to materials and biocompatibility.
VII. Performance Data:
The performance of the subject devices are demonstrated through mechanical testing of plates and screws according to ASTM F382, ASTM F3437 and ASTM F543, respectively. Based on submitted testing data, the subject device is equivalent to the predicate devices.
VIII. Conclusions:
The Versalock Mini and Micro Plating System has the basic design features and intended use as the predicates. Any differences between them are considered minor and do not raise questions concerning safety or effectiveness. Based on the information provided, GMReis has determined that the proposed device is substantially equivalent to the predicate devices.