(258 days)
No
The device description and intended use are solely focused on mechanical fixation components (plates, screws, cables) for bone fractures. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
No
Explanation: The device is intended for temporary internal fixation and stabilization of fractures and osteotomies of the femur, which is a structural rather than a therapeutic function. It provides mechanical support for healing, but does not directly treat a disease or condition in a therapeutic manner.
No
The device is described as a system of plates, screws, and a cerclage cable intended for "temporary internal fixation and stabilization of fractures and osteotomies of the femur," which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is composed of plates, screws, a cerclage cable, and related devices, all of which are physical hardware components made of titanium alloy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "temporary internal fixation and stabilization of fractures and osteotomies of the femur." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details plates, screws, and cables designed to be implanted into bone for structural support.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or support the body's structure. This device is a surgical implant.
N/A
Intended Use / Indications for Use
The Versalock Periprosthetic Femur Plates is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the femur, including:
- · Periprosthetic fractures
- Comminuted fractures
- Supracondylar fractures
- Trochanteric fractures
- · Fractures in normal and osteopenic bone
- Non-unions and Malunions.
Product codes
HRS, JDP, HWC, JDQ
Device Description
The purpose of this submission is to obtain marketing clearance for the Versalock Periprosthetic Femur Plates System which is composed of plates, screws and, a cerclage cable and related device.
The subject devices are designed for the treatment of femur fractures, particularly, periprosthetic femur fractures. The plates are available in the following design-types to be used according to the fracture location: Proximal and Distal Femur Periprosthetic Plates, Trochanteric Periprosthetic Plates and Condylar Femur Plates.
The plates are for use with the subject device screws to fix them to the bone. The following compatible screws are available for this purpose: Cortical Screws, Versalock Variable Angle Locking Screws, Versalock Variable Angle Screws, Versalock Variable Angle Cannulated Screws and Versalock Variable Angle Periprosthetic Screw. The Trochanteric Plate Fastening Screw is to connect one plate to another when a Trochanteric Periprosthetic Plates is used. The Versalock Spacer Screw is threaded into the plate hole prior to plate insertion to act as a spacer providing no contact between the plate and the bone surface.
The Gama Cable is a cerclage cable indicated to provide fixation and/or stabilization of the bone when it is not possible the usage of any screw. The Gama Cable related devices are the Gama Cable Lock and the Versalock Connector Screw. During the installation of the Gama Cable Lock is crimped to lock the movement of the cable, maintaining the tensioning applied while the Versalock Connector Screw , which holds the cable to the plate and set the proper cable routing position. The Gama Cable and related devices are used in conjunction with the Proximal or Distal Femur Periprosthetic Plates, or Condylar Femur Plates
The subject devices are made of made of titanium alloy (ASTM F136) with exception of the Gama Cable Lock which it is made of commercially pure titanium (ASTM F67). All the subject devices are coloredanodized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.
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)
Biocompatibility was established through a risk assessment following ISO 10993-1.
The performance of the subject device plates was demonstrated through static and dynamic testing according to ASTM F382.
The performance of the subject screws was demonstrated through mechanical testing according to ASTM F543.
The performance of the cerclage cable was demonstrated through mechanical testing according to ASTM F2180 and system construct testing.
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K082527, K110354, K151907, K081759, K061211, K151716, K100111, K161616, K042695, K162124, K182718
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 8, 2021
GM dos Reis Industria e Comercio Ltda % Janine Treter Regulatory Affairs Specialist PR Servicos Regulatorios Administrativos Ltda Rua Alice Alem Saadi, 855/2402 Ribeirao Preto, Sao Paulo 14096-570 Brazil
Re: K201728
Trade/Device Name: Versalock Periprosthetic Femur Plates System-GMReis Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, JDP, HWC, JDQ Dated: January 22, 2021 Received: January 29, 2021
Dear Janine Treter:
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 (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 located 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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201728
Device Name
Versalock Periprosthetic Femur Plates System - GMReis
Indications for Use (Describe)
The Versalock Periprosthetic Femur Plates is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the femur, including:
- · Periprosthetic fractures
- Comminuted fractures
- Supracondylar fractures
- Trochanteric fractures
- · Fractures in normal and osteopenic bone
- Non-unions and Malunions.
Type of Use (Select one or both, as applicable)|X 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 PRAStaff(@fda.hhs.gov
"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."
3
and accessories; Smooth or threaded metallic bone fixation
21 CFR 888.3030, 21 CFR 888.3040, 21 CFR 888.3010
fastener; Bone fixation cerclage.
HRS, JDP, HWC, JDQ
Orthopedic
| 510(k) Summary | |
|---|---|
| ADMINISTRATIVE INFORMATION | |
| Sponsor/Manufacturer Name | GM dos Reis Indústria e Comércio Ltda |
| Avenida Pierre Simon de La Place 600 | |
| Campinas, São Paulo, Brazil 13069-320 | |
| Telephone: +55 (19) 3765-9900 | |
| Contact person: Paula Oliveira, Quality Manager | |
| Submission contact | Graziela Brum |
| Regulatory Affairs Specialist | |
| Passarini Regulatory Affairs | |
| PR Serviços Regulatórios Administrativos Ltda | |
| E-Mail: graziela@rapassarini.com.br | |
| Telephone +55 (47) 3804 0075 | |
| Preparer | Janine Treter and Graziela Brum |
| Regulatory Affairs Specialist | |
| Passarini Regulatory Affairs | |
| PR Serviços Regulatórios Administrativos Ltda | |
| E-Mail: graziela@rapassarini.com.br | |
| Telephone +55 (47) 3804 0075 | |
| Date Prepared | 05/march/2021 |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | Versalock Periprosthetic Femur Plates System - GMReis |
| Common Name | Plate, Fixation, Bone; Condylar Plate Fixation Implant; Screw, |
| Fixation, Bone; Cerclage, Fixation. | |
| Classification Name | Single/multiple component metallic bone fixation appliances |
Product Code
Review Panel
Classification Regulation
4
PREDICATE DEVICE INFORMATION
| Primary Predicate Device | K120772 - NCB Periprosthetic Trochanter Plates and Screws and NCB Cable Button for NCB Polyaxial Locking Plate - Zimmer, GmbH |
|---|---|
| Reference Devices | K082527- Zimmer® Universal Locking System: 3.5 mm Locking Plates and Screw (Tivanium® Ti-6A1-4V Alloy, CP Grade Titanium) - Zimmer, Inc. |
| K110354- Synthes 4.5mm VA-LCP Curved Condylar Plate System - Synthes (USA) | |
| K151907 - Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm - Zimmer, Inc. | |
| K081759 - NCB® Polyaxial Locking Plate System, Proximal Humeral Plates and Zimmer® Universal Locking System; 3.5mm Tivanium® Ti-6A1-4V Alloy Locking Screws - Zimmer, GmbH | |
| K061211- NCB® Plating System - Zimmer, GmbH | |
| K151716- Cable-Ready® Cable Grip System: Cable-Ready® Bone Plate System - Zimmer, Inc. | |
| K100111- NCB® Periprosthetic Femur Polyaxial Locking Plate System - Zimmer, Inc. | |
| K161616- DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw - Zimmer, GmbH | |
| K042695 Single/multiple component metallic bone fixation appliances and accessories, Smooth threaded metallic bone fixation fastener - Zimmer, GmbH | |
| K162124 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins - Depuy Synthes | |
| K182718 - Mini and Micro Fragments Reconstruction System – GMReis |
INDICATIONS FOR USE
The Versalock Periprosthetic Femur Plates System – GMReis is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the femur, including:
- Periprosthetic fractures
- . Comminuted fractures
5
- Supracondylar fractures
- . Trochanteric fractures
- Fractures in normal and osteopenic bone
- . Non-unions and Malunions
DEVICE DESCRIPTION
The purpose of this submission is to obtain marketing clearance for the Versalock Periprosthetic Femur Plates System which is composed of plates, screws and, a cerclage cable and related device.
The subject devices are designed for the treatment of femur fractures, particularly, periprosthetic femur fractures. The plates are available in the following design-types to be used according to the fracture location: Proximal and Distal Femur Periprosthetic Plates, Trochanteric Periprosthetic Plates and Condylar Femur Plates.
The plates are for use with the subject device screws to fix them to the bone. The following compatible screws are available for this purpose: Cortical Screws, Versalock Variable Angle Locking Screws, Versalock Variable Angle Screws, Versalock Variable Angle Cannulated Screws and Versalock Variable Angle Periprosthetic Screw. The Trochanteric Plate Fastening Screw is to connect one plate to another when a Trochanteric Periprosthetic Plates is used. The Versalock Spacer Screw is threaded into the plate hole prior to plate insertion to act as a spacer providing no contact between the plate and the bone surface.
The Gama Cable is a cerclage cable indicated to provide fixation and/or stabilization of the bone when it is not possible the usage of any screw. The Gama Cable related devices are the Gama Cable Lock and the Versalock Connector Screw. During the installation of the Gama Cable Lock is crimped to lock the movement of the cable, maintaining the tensioning applied while the Versalock Connector Screw , which holds the cable to the plate and set the proper cable routing position. The Gama Cable and related devices are used in conjunction with the Proximal or Distal Femur Periprosthetic Plates, or Condylar Femur Plates
The subject devices are made of made of titanium alloy (ASTM F136) with exception of the Gama Cable Lock which it is made of commercially pure titanium (ASTM F67). All the subject devices are coloredanodized.
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.
6
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the following predicate device:
K120772 - NCB Periprosthetic Trochanter Plates and Screws and NCB Cable Button for NCB Polyaxial Locking Plate - Zimmer, GmbH
The subject and predicate devices have equivalent intended use and equivalent technological characteristics. The subject and predicate devices are all manufactured from identical or equivalent materials and share equivalent design characteristics. The subject and predicate devices encompass equivalent physical dimensions and are to be sterilized by identical or equivalent method. Any difference in the technological characteristics do not raise new issues of safety or efficacy.
Biocompatibility was established through a risk assessment following ISO 10993-1.
The performance of the subject device plates was demonstrated through static and dynamic testing according to ASTM F382.
The performance of the subject screws was demonstrated through mechanical testing according to ASTM F543.
The performance of the cerclage cable was demonstrated through mechanical testing according to ASTM F2180 and system construct testing.
No clinical data were included in this submission.
The subject devices are provided non-sterile and have no expiration date defined.
CONCLUSION
The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate devices.