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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Versalock Periprosthetic Femur Plates System - GMReis. This document outlines the regulatory submission for a medical device and, as such, does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, many of the requested sections related to clinical studies, sample sizes for test and training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance will not be available in this document.

Here's a breakdown of the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of explicit acceptance criteria with specific numerical targets. Instead, it states that performance was demonstrated through mechanical testing according to established ASTM standards. The "performance" in this context refers to the device's mechanical integrity and functionality, rather than a clinical outcome.

Acceptance Criteria (Standard Adherence)	Reported Device Performance (Demonstrated Adherence)
Adherence to ASTM F382 for plates (static and dynamic testing)	Performance of subject device plates was demonstrated through static and dynamic testing according to ASTM F382.
Adherence to ASTM F543 for screws (mechanical testing)	Performance of subject screws was demonstrated through mechanical testing according to ASTM F543.
Adherence to ASTM F2180 for cerclage cable (mechanical testing)	Performance of the cerclage cable was demonstrated through mechanical testing according to ASTM F2180.
System construct testing for cerclage cable	Performance of the cerclage cable was demonstrated through system construct testing.
Biocompatibility established via risk assessment following ISO 10993-1	Biocompatibility was established through a risk assessment following ISO 10993-1.
Equivalence in indications for use, design principles, materials, physical dimensions, and sterilization method to predicate device	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.
No new issues of safety or efficacy raised by technological differences	Any difference in the technological characteristics do not raise new issues of safety or efficacy.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. This document describes mechanical testing of physical device components, not a study involving patient data or a "test set" in the context of AI/diagnostic device performance. The sample sizes would refer to the number of plates, screws, and cables tested in the lab. This specific number is not provided, though it would typically be defined by the ASTM standards.
Data Provenance: Not applicable. The data comes from internal mechanical testing, not patient data from a specific country or collected retrospectively/prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth as typically defined for diagnostic AI/clinical studies (e.g., expert consensus on images, pathology results) is not relevant to this type of device submission. The "ground truth" here is the adherence to mechanical engineering standards, which is determined by test procedures and measurement against those standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for the reasons stated above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not a diagnostic AI device, and therefore, an MRMC study is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a physical medical implant device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical performance (mechanical testing), the "ground truth" is adherence to established engineering standards (ASTM F382, ASTM F543, ASTM F2180) and a risk assessment based on biocompatibility standards (ISO 10993-1).
For the substantial equivalence claim, the "ground truth" is the characteristics of the predicate device, which the subject device is compared against.

8. The sample size for the training set:

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. There is no training set.

Summary

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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.

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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

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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)

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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 LtdaAvenida Pierre Simon de La Place 600Campinas, São Paulo, Brazil 13069-320Telephone: +55 (19) 3765-9900Contact person: Paula Oliveira, Quality Manager
Submission contact	Graziela BrumRegulatory Affairs SpecialistPassarini Regulatory AffairsPR Serviços Regulatórios Administrativos LtdaE-Mail: graziela@rapassarini.com.brTelephone +55 (47) 3804 0075
Preparer	Janine Treter and Graziela BrumRegulatory Affairs SpecialistPassarini Regulatory AffairsPR Serviços Regulatórios Administrativos LtdaE-Mail: graziela@rapassarini.com.brTelephone +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

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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

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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 devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.

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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.

Regulation Number and Section

§ 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.