(88 days)
No
The document describes a mechanical fixation system made of titanium and UHMWPE sutures, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is designed to provide fixation during the healing process, acting as a support structure for bones, ligaments, and tendons after injury or repair, rather than directly treating a disease or therapeutic condition.
No
The device is described as a "Flexible Joint Fixation System" intended for "fracture repair" and "fixation during the healing process." It is a biomechanical structure designed to simulate a support pillar distributing tensions, not to diagnose medical conditions.
No
The device description explicitly states the device is manufactured from titanium alloy and UHMWPE, indicating it is a physical implant and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- EXPERT - Flexible Joint Fixation System Function: The description clearly states that this device is a surgical implant used for fixation during the healing process of fractures and ligament/tendon repairs. It is a physical structure implanted within the body to provide support.
The intended use, device description, and anatomical sites all point to a device used in vivo (within the body) for structural support, not for analyzing biological samples in vitro.
N/A
Intended Use / Indications for Use
The EXPERT - Flexible Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting. The EXPERT - Flexible Joint Fixation System are intended to provide fixation during the healing process following:
EXPERT FAST - SYNDESMOSIS and EXPERT FAST DUAL:
Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
EXPERT ACL and EXPERT ACL II:
Fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, these models are offered for Anterior Cruciate Ligament (ACL) Repair.
EXPERT FAST - CORACOID PLATE and EXPERT FAST- AC:
Specifically, these models are intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
Product codes
HTN
Device Description
The EXPERT - Flexible Joint Fixation System was designed for fixation, being used as a biomechanical structure to simulate a support pillar distributing the tensions in the suture wire or tape. The plates are manufactured in titanium alloy conforming to ASTM F136. The sutures are manufactured from UHMWPE.
The devices are sold sterile and are single use. The EXPERT - Flexible Joint Fixation System is a line extension to the EXPERT - Joint Fixation System consisting of new models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, bone to bone, soft tissue to bone, ligament, tendon, Anterior Cruciate Ligament (ACL), acromioclavicular
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)
Based on submitted testing data, the proposed EXPERT - Flexible Joint Fixation System is equivalent to the Arthrex ACL TightRope (K100652) and TightRopeTM Acromioclavicular (K052776) predicate devices. This predicates equivalence supports the inclusion of the proposed indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EXPERT - Joint Fixation System (K200332), ACL TightRope (K100652), TightRopeTM Acromioclavicular (AC) Device (K052776)
Reference Device(s)
Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors (K223114)
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.
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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, 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.
October 1, 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: K242311
Trade/Device Name: EXPERT - Flexible Joint Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: July 29, 2024 Received: August 5, 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 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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Indications for Use
Submission Number (if known)
Device Name
EXPERT - Flexible Joint Fixation System
Indications for Use (Describe)
The EXPERT - Flexible Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and castina. The EXPERT - Flexible Joint Fixation System are intended to provide fixation during the healing process following:
EXPERT FAST - SYNDESMOSIS and EXPERT FAST DUAL:
Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
EXPERT ACL and EXPERT ACL II:
Fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, these models are offered for Anterior Cruciate Ligament (ACL) Repair.
EXPERT FAST - CORACOID PLATE and EXPERT FAST- AC:
Specifically, these models are intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
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.
K242311 510(k) Summary Premarket Notification 510(k) - FDA
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: July 29, 2024
II. Device Name:
| Trade Name: | EXPERT - Flexible Joint Fixation System |
|---|---|
| Common Name: | Washer, Bolt Nut |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories |
| Device Class: | II |
| Product Codes: | HTN |
| Regulation Number: | 21 CFR 888.3030 |
III. Predicate Devices:
Legally marketed devices to which we are claiming "Substantial Equivalence" are the following: EXPERT - Joint Fixation System (K200332) (Primary predicate device): ACL TightRope (K100652) (Additional predicate device); TightRope™ Acromioclavicular (AC) Device (K052776) (Additional predicate device); Suture Anchors - HTA Headless Titanium Anchor and ZIP Anchors (K223114) (Reference device).
IV. Device Description:
The EXPERT - Flexible Joint Fixation System was designed for fixation, being used as a biomechanical structure to simulate a support pillar distributing the tensions in the suture wire or tape. The plates are manufactured in titanium alloy conforming to ASTM F136. The sutures are manufactured from UHMWPE.
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 has a circular design on the left side with a red and blue color scheme. To the right of the circular design is the text "GMREIS" in a bold, blue font. Below the text "GMREIS" is the text "Qualidade para Vida" in a smaller, blue font.
K242311 510(k) Summary Premarket Notification 510(k) - FDA
The devices are sold sterile and are single use. The EXPERT - Flexible Joint Fixation System is a line extension to the EXPERT - Joint Fixation System consisting of new models.
V. Statement of Indications for Use of the Device:
The EXPERT - Flexible Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting. The EXPERT - Flexible Joint Fixation System are intended to provide fixation during the healing process following:
EXPERT FAST - SYNDESMOSIS and EXPERT FAST DUAL:
Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
EXPERT ACL and EXPERT ACL II:
Fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, these models are offered for Anterior Cruciate Ligament (ACL) Repair.
EXPERT FAST - CORACOID PLATE and EXPERT FAST- AC:
Specifically, these models are intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
VI. Comparison of Technological Characteristics with The Predicate Device:
The proposed device is a line extension to the predicate device. The proposed and predicate devices have the same basic design, intended use, packaging, shelf life, biocompatibility profile, materials, and sterilization. Differences between the proposed device and the predicate include additional models and indications. The proposed EXPERT - Flexible Joint Fixation System is substantially equivalent to the predicate device in which the basic design features and intended use are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise new or different questions concerning safety or effectiveness.
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Image /page/6/Picture/0 description: The image contains the logo for GMREIS. 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 blue, with the tagline "Qualidade para Vida" (Quality for Life) underneath in a smaller font.
K242311 510(k) Summary Premarket Notification 510(k) - FDA
VII. Performance Data:
Based on submitted testing data, the proposed EXPERT - Flexible Joint Fixation System is equivalent to the Arthrex ACL TightRope (K100652) and TightRopeTM Acromioclavicular (K052776) predicate devices. This predicates equivalence supports the inclusion of the proposed indications.
VIII. Conclusions:
The EXPERT - Flexible Joint Fixation System is substantially equivalent to the predicate device in which the basic design features and intended use are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise and different questions concerning safety or effectiveness. Based on the indications for use, technological characteristics, and the summary of data submitted. GMReis has determined that the proposed device is substantially equivalent to the currently marketed predicate device.