(56 days)
No
The device description and performance studies focus on mechanical properties and traditional surgical implants, with no mention of AI or ML.
Yes
This device is intended for internal bone fixation for fractures, fusions, osteotomies, and non-unions, which are therapeutic interventions.
No
This device is for internal bone fixation and reconstructive surgery, not for identifying or determining the nature of a disease or condition.
No
The device description explicitly states it consists of physical components (plates and screws made of titanium alloy or pure titanium) and describes their dimensions and materials. It also mentions mechanical testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Versalock Upper Limb Plating System is for "internal bone fixation for bone fractures, fusions, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, and ulna." This describes a surgical implant used to physically stabilize bones within the body.
- Device Description: The description details plates and screws made of titanium alloy or pure titanium, designed for trauma and reconstructive surgery. This further confirms its nature as a surgical implant.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on bodily samples.
The Versalock Upper Limb Plating System is a surgical implant used for orthopedic procedures, not an IVD.
N/A
Intended Use / Indications for Use
Versalock Upper Limb Plating System are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, and ulna.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
Versalock Upper Limb 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 titanium alloy or pure titanium. The plates range in thickness from 1.4 to 3.5 mm, and the screws range in diameter from 2.0 to 3.5 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture. Versalock Upper Limb Plating System are for single use and the devices are provided non-sterile. They must be 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
clavicle, scapula, olecranon, humerus, radius, and ulna
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 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.
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 shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 29, 2025
GM Dos Reis Industria e Comercio Ltda Guilherme Esteves Pontes Regulatory Affairs Analyst Avenida Pierre Simon de LaPlace. 600 Campinas, SP 13069320 Brazil
Re: K243740
Trade/Device Name: Versalock Upper Limb 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: December 2, 2024 Received: December 4, 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,
Thomas Mcnamara -S
For: Christopher Ferriera, 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Versalock Upper Limb Plating System
Indications for Use (Describe)
Versalock Upper Limb Plating System are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, and ulna.
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/0 description: The image shows the logo for GMREIS. The logo consists of a circular graphic on the left and the text "GMREIS" on the right. Below the text is the phrase "Qualidade para Vida". The circular graphic is blue and red.
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: December 2, 2024
II. Device Name:
| Trade Name: | Versalock Upper Limb 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: Fracture Plates (K123241) (Primary predicate device); Synthes (usa) Lcp Proximal Humerus Plates, Long (K041860) (Additional Predicate device) Mini and Micro Fragments Reconstruction System - GMReis (K182718) (Reference device); Cut Screw - Percutaneous Compression Screw (K230397) (Reference device). EXPERT - Joint Fixation System (K200332) (Reference device).
IV. Device Description:
Versalock Upper Limb 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 titanium alloy or pure titanium. The plates range in thickness from 1.4 to 3.5 mm, and the screws range in
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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Image /page/5/Picture/0 description: The image is a logo for GMREIS. The logo features a blue and red circular design on the left, with the text "GMREIS" in blue to the right. Below the text is the phrase "Qualidade para Vida" in a smaller font, also in blue. The logo appears to be for a company or organization that focuses on quality of life.
| K243740 | |
|---|---|
| Revision: | 00 |
| Sheet: | 2/2 |
diameter from 2.0 to 3.5 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture.
Versalock Upper Limb Plating System are for single use and the devices are provided non-sterile. They must be 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 Upper Limb Plating System are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, and ulna.
VI. Comparison of Technological Characteristics with The Predicate Device:
The subject, the predicate and the reference devices have the same basic design and intended use. Both are manufactured and 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 reference device in K182718, K230397 and K200332 and therefore are substantially equivalent to the predicates with regard to materials, packaging and biocompatibility. The subject and primary predicate are similar in design and are both manufactured in titanium alloy. The subject system is different because of its specific geometry and contains additional plate designs as compared to the cited predicate.
VII. Performance Data:
The performance of the subject devices are demonstrated through mechanical testing of plates and screws according to ASTM F382 and ASTM F543, respectively. Based on submitted testing data, the subject device is equivalent to the predicate devices.
VIII. Conclusions:
The subject devices has basic design features and intended use as the predicate. 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 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