Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries for internal fixation of discontinued bone structures. The product are not to be used in conjunction with other bone fixation implants, like plates. The surgical sutures and tapes are made of UHMWPE (ultra-high molecular weight polyethylene), the needles are made in AISI300 steel series, according to the standard ASTM F899 and cerclage is assembled on an ABS loader, additional instruments may be used as well. Those materials are identical to those used in other cleared GMReis devices like the reference device cleared under K223114. It is provided in sterile condition sterilized by Ethylene Oxide.

AI/ML Overview

Based on the provided FDA 510(k) clearance letter for the Stitch Cerclage - Suture System, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is an FDA 510(k) clearance letter, which means the device has already been cleared. This letter summarizes the regulatory decision and mentions that studies were performed, but it does not contain the detailed study protocols, results, or data itself. Therefore, I will extract all available information and explicitly state when information is not present in this document.

Acceptance Criteria and Device Performance Study Summary

The acceptance criteria for this device are largely implied through the comparison to a predicate device and the successful completion of specified mechanical tests. The performance study focused on demonstrating substantial equivalence to the predicate device, particularly in mechanical properties relevant to its intended use as a bone fixation cerclage.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Material Equivalence: Made of materials safe and equivalent to predicate devices.	The device is made of UHMWPE (ultra-high molecular weight polyethylene) for sutures/tapes and AISI300 steel series for needles, which are identical to those used in other cleared GMReis devices (Reference Device K223114) and are considered equivalent to the predicate device.
Design Equivalence: Shares equivalent design characteristics with predicate devices.	The device has “equivalent design characteristics as well as physical dimensions” compared to the predicate. Minor differences "do not raise new issues of safety or efficacy."
Mechanical Performance: Performance is comparable or superior to the predicate device in relevant mechanical tests (chemical composition, creep, tension static, fatigue).	Performance was demonstrated through mechanical testing (chemical composition, creep test, tension static, and fatigue tests). The specific results are not provided in this document, but the conclusion states: "We therefore consider the subject device equivalent to its predicate device in the mechanical tests performed." The methodology was based on the article "Cerclage Performance Analysis – a Biomechanical Comparison of Different Techniques and Materials", L. M. Hägerich, et al, Musculoskeletal Disorders (2022).
Sterility: Provided in a sterile condition via a validated method.	The device is provided in sterile condition, sterilized by Ethylene Oxide, which is a common and accepted sterilization method.
Biocompatibility: Materials are biocompatible for implantation.	While not explicitly detailed as a separate test, the use of UHMWPE and AISI300 steel, which are "identical to those used in other cleared GMReis devices" and are common in medical devices, implies that their biocompatibility has been previously established and met.
Substantial Equivalence: Overall device is substantially equivalent to legally marketed predicate devices in terms of indications for use, technological characteristics, and safety/effectiveness.	The submission concludes that the device is "substantially equivalent" to the predicate in "intended use, indications for use, material composition, anatomical region, multiple sizes, and basic design features." The mechanical testing supported this claim, with no new issues of safety or effectiveness identified.

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes (e.g., number of test specimens, number of cycles for fatigue) used for the mechanical testing. It mentions "chemical composition, creep test, tension static and fatigue tests."
Data Provenance: The studies were conducted by the manufacturer, GM Dos Reis Industria e Comercio Ltda, which is based in Campinas, Brazil. The data is based on mechanical testing, not clinical data, and therefore is not characterized as retrospective or prospective in the usual clinical sense. It's laboratory-based performance data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For this type of mechanical device clearance, "ground truth" is established through engineering standards, validated test methodologies, and comparison to the known performance of predicate devices.
The document does not mention the use of human experts (like radiologists) for "ground truth" establishment as would be common for AI/imaging device clearances. The "experts" involved would be engineering and quality control personnel at the manufacturer and potentially external testing laboratories, ensuring compliance with test methodologies.

4. Adjudication Method for the Test Set

Since this is a mechanical device performance study, no explicit "adjudication method" in the sense of clinician consensus on medical images is applicable or mentioned. The "adjudication" is inherent in the adherence to established mechanical testing protocols and statistical analysis of the results to demonstrate equivalence to the predicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This type of study is specifically relevant for imaging devices or AI algorithms where human readers' performance is being evaluated or augmented. The Stitch Cerclage Suture System is a physical medical device, not an imaging or AI diagnosis system.
The document explicitly states: "No clinical data were included in this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This concept pertains to AI algorithms. The Stitch Cerclage Suture System is a physical product and does not have an "algorithm-only" performance component.

7. Type of Ground Truth Used

The "ground truth" for this device type is established through objective, quantifiable mechanical properties and material composition, compared against established industry standards (where available) or the performance of a legally marketed predicate device.
Specifically, the study compared "chemical composition, creep test, tension static and fatigue tests" to information from a published article ("Cerclage Performance Analysis – a Biomechanical Comparison of Different Techniques and Materials", L. M. Hägerich, et al, Musculoskeletal Disorders (2022)) and to the predicate device.

8. Sample Size for the Training Set

Not applicable / Not mentioned. This device is a physical product, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process would involve internal validation and verification activities, but this is distinct from training an AI model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI "training set," there is no ground truth established for one. The "ground truth" for the device's design and manufacturing is derived from engineering principles, relevant material standards (e.g., ASTM F899 for steel), and performance expectations set by the predicate device.

Summary

FDA 510(k) Clearance Letter - Stitch Cerclage Suture System

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August 14, 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: K243905
Trade/Device Name: Stitch - Cerclage Suture System
Regulation Number: 21 CFR 888.3010
Regulation Name: Bone Fixation Cerclage
Regulatory Class: Class II
Product Code: JDQ
Dated: July 16, 2025
Received: July 16, 2025

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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K243905 - Guilherme Esteves Pontes Page 2

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 (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 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-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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K243905 - Guilherme Esteves Pontes Page 3

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, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K243905

Device Name
Stitch Cerclage - Suture Tapes

Indications for Use (Describe)
Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries as bone fixation cerclage, specifically:

Sternotomy indications including the "rewiring" of osteomized sternums;
Repair of long bone fractures due to trauma or reconstruction.

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)

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
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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."

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K243905 - Stitch Cerclage - Suture Tapes

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

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, Senior Regulatory Affairs Analyst
Telephone: +55 (19) 3765‐9900
Email: guilherme.qualidade@gmreis.com.br
Date prepared: December 16, 2024

II. Device Name:

Trade Name: Stitch Cerclage - Suture Tapes
Common Name: Cerclage, Fixation
Classification Name: Bone fixation cerclage
Device Class: II
Product Codes: JDQ
Regulation Number: 21 CFR 888.3010

III. Predicate Devices:

Legally marketed device to which we are claiming "Substantial Equivalence" are the following:
Arthrex FiberTape and TigerTape Cerclage Sutures - Arthrex (K221485) (Predicate Device)
Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors - GMReis (K223114) (Reference Device)
EXPERT - Joint Fixation System (K200332) (Reference Device)

IV. Device Description:

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K243905 - Stitch Cerclage - Suture Tapes

ABS loader, additional instruments may be used as well. Those materials are identical to those used in other cleared GMReis devices like the reference device cleared under K223114. It is provided in sterile condition sterilized by Ethylene Oxide.

V. Statement of Indications for Use of the Device:

Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries as bone fixation cerclage, specifically:

Sternotomy indications including the "rewiring" of osteomized sternums;
Repair of long bone fractures due to trauma or reconstruction.

VI. Comparison of Technological Characteristics with The Predicate Device:

The subject device is substantially equivalent in indications and design principles to the following predicate device: K221485 - Arthrex FiberTape and TigerTape Cerclage Sutures - Arthrex Inc.

The subject and predicate device have equivalent intended use and equivalent 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 literature and predicate comparison. No clinical data were included in this submission. The subject device is provided sterile by Ethylene Oxide method.

VII. Performance Data:

The chemical composition, creep test, tension static and fatigue tests conducted with the products were based on the article "Cerclage Performance Analysis – a Biomechanical Comparison of Different Techniques and Materials", L. M. Hägerich, et al, Musculoskeletal Disorders (2022) and compared to the predicate device. The methodology of this literature was used because there is no international standard in the ISO – International Standardization Organization nor in the ASTM – American Standardization for Testing and Materials for testing these types of products. We therefore consider the subject device equivalent to its predicate device in the mechanical tests performed.

VIII. Conclusions:

As was established in this submission, the subject Stitch Cerclage - Suture Tapes are substantially equivalent to the predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics, intended use, indications for use, material composition, anatomical region, multiple sizes, and basic design features

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K243905 - Stitch Cerclage - Suture Tapes

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.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.