(262 days)
No
The device description and intended use focus on mechanical fixation components (plates, sutures, meshes) and surgical instruments. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on mechanical testing, not algorithmic performance.
Yes.
The device is intended to provide fixation during the healing process following various injuries, which is a therapeutic function.
No
The device is intended for fracture repair and fixation during the healing process, not for diagnosing conditions.
No
The device description explicitly states it is composed of physical medical devices like plates, surgical sutures, surgical meshes, and a guidewire, all made of specific materials. It also mentions associated instruments. This indicates a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in vivo (within the body) for fracture repair and fixation of bone and soft tissue. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is composed of metallic plates, surgical sutures, and surgical meshes, which are implanted into the body. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the EXPERT - Joint Fixation System is a surgical implant used for orthopedic procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EXPERT - 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 Mini EXPERT, EXPERT Knotless and EXPERT Knotless Dual are intended to provide fixation during the healing process following:
Mini EXPERT
When used for fixation of bone, the Mini EXPERT is intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair, such as:
-
Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
-
Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
-
Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the ligament at the base of the thumb metacarpal by providing stabilization between the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
EXPERT Knotless and EXPERT Knotless Dual
Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
Product codes
HTN
Device Description
The EXPERT – Joint Fixation System is available in three models. Each model is composed of different medical devices (i.g. plates, surgical suture) assembled together for the purpose of use as a set. Each set is composed of plates from different sizes and shapes made of Titanium Alloy (ASTM F136) associated with non-absorbable surgical sutures and/or surgical meshes made of an Ultra-High Molecular Weight Polyethylene (UHMWPE).
The metallic components are manufactured by GM dos Reis Indústria e Comércio Ltda and the nonabsorbable Surgical Sutures and Surgical Suture Meshes are purchased in bulk from River Point Medical (K100006).
Each EXPERT model comes with a transient use guidewire accessory in the same package. The guidewire is made of Stainless Steel (ASTM F138) to aid in the EXPERT - Joint Fixation System placement.
In order to promote a correct placement of EXPERT – Joint Fixation System, GMReis has also available a range of instruments (class I exempt) to serve the surgeon such as drill bits, drill guides, plier, among others. GMReis recommends the use of these instruments in order to ensure the compatibility with the subject devices and promote the success of the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Metaphyseal and periarticular bone fragments of dorsal distal radioulnar ligament (DRUL), Tarsometatarsal (TMT) injury, foot soft tissue, Lisfranc injury (Midfoot Reconstruction), Carpal Metacarpal (CMC) joint, base of the thumb metacarpal, syndesmosis, ankle
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)
The performance of the subject devices compared with the predicate devices are demonstrated through mechanical testing. No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K090107, K061925, K043248, K111032
Reference Device(s)
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
October 29, 2020
GM dos Reis Industria e Comercio Ltda % Graziela Brum Regulatory Affairs Specialist PR Servicos Regulatorios Administrativos Ltda Rua Alice Alem Saadi, 855/2402 Ribeirao Preto, 14096-570 Brazil
Re: K200332
Trade/Device Name: EXPERT - 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: September 29, 2020 Received: October 2, 2020
Dear Graziela Brum:
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.
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
1
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 mediation-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,
Laura C. Rose, Ph.D. 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
510(k) Number (if known) K200332
Indications for Use (Describe)
EXPERT - Joint Fixation System
The EXPERT - 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 Mini EXPERT, EXPERT Knotless and EXPERT Knotless Dual are intended to provide fixation during the healing process following:
Mini EXPERT
When used for fixation of bone, the Mini EXPERT is intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair, such as:
-
Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
-
Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
-
Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the ligament at the base of the thumb metacarpal by providing stabilization between the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
EXPERT Knotless and EXPERT Knotless Dual
Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
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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510(k) Summary
ADMINISTRATIVE INFORMATION
| Labels | Values |
|---|---|
| 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 |
| Prepared by | Janine Treter and Graziela Brum Passarini Regulatory Affairs PR Serviços Regulatórios Administrativos Ltda E-Mail: graziela@rapassarini.com.br Telephone +55 (16) 3421-8488 |
| Submission date | 29/Sep/2020 |
DEVICE NAME AND CLASSIFICATION
| Labels | Values |
|---|---|
| Trade/ Proprietary Name | EXPERT - Joint Fixation System |
| Common Name | Washer, Bolt Nut |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories |
| Product Code | HTN |
| Classification Regulation | 21 CFR 888.3030, Class II |
| Review Panel | Orthopedic |
PREDICATE DEVICE INFORMATION
| Labels | Values |
|---|---|
| Predicate Devices | K090107 - Mini TightRope - Arthrex, Inc. K061925- Mini TightRopeTM Repair Kit - Arthrex, Inc. K043248 - Arthrex TightRope™ Syndesmosis Devices, Arthrex, Inc. K111032 - CMC Cable FIX - Instratek, Inc. |
| Reference Devices | K100006 - Polyester Non-absorbable Surgical Suture, Polyblend Non- absorbable Surgical Suture, Silk Non-absorbable Surgical Suture, Polypropylene Surgical Suture, Nylon Non-absorbable Surgical Suture, Riverpoint Medical K180626 - Pedimax II - Pedicular Screw Spinal System - GM dos Reis Industria E Comercio Ltda K182718 - Mini and Micro Fragments Reconstruction System - GMReis - GM dos Reis Industria E Comercio Ltda |
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INDICATIONS FOR USE
The EXPERT – 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 Mini EXPERT, EXPERT Knotless and EXPERT Knotless Dual are intended to provide fixation during the healing process following:
Mini EXPERT
When used for fixation of bone-to-bone, the Mini EXPERT is intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair, such as:
-
Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;
-
Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
-
Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the reconstruction of the ligament at the base of the thumb metacarpal by providing stabilization between the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
EXPERT Knotless and EXPERT Knotless Dual
Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
DEVICE DESCRIPTION
The EXPERT – Joint Fixation System is available in three models. Each model is composed of different medical devices (i.g. plates, surgical suture) assembled together for the purpose of use as a set. Each set is composed of plates from different sizes and shapes made of Titanium Alloy (ASTM F136) associated with non-absorbable surgical sutures and/or surgical meshes made of an Ultra-High Molecular Weight Polyethylene (UHMWPE).
The metallic components are manufactured by GM dos Reis Indústria e Comércio Ltda and the nonabsorbable Surgical Sutures and Surgical Suture Meshes are purchased in bulk from River Point Medical (K100006).
Each EXPERT model comes with a transient use guidewire accessory in the same package. The guidewire is made of Stainless Steel (ASTM F138) to aid in the EXPERT - Joint Fixation System placement.
In order to promote a correct placement of EXPERT – Joint Fixation System, GMReis has also available a range of instruments (class I exempt) to serve the surgeon such as drill bits, drill guides, plier, among others. GMReis recommends the use of these instruments in order to ensure the compatibility with the subject devices and promote the success of the procedure.
5
The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the following predicate devices:
K090107 - Mini TightRope - Arthrex, Inc. K061925- Mini TightRope™ Repair Kit - Arthrex, Inc.. K043248 - Arthrex TightRope™ Syndesmosis Devices, Arthrex, Inc. K111032 - CMC Cable FIX - Instratek, Inc.
The subject device and the 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 method. Any differnce in the technological characteristics do not raise new issues of safety or efficacy.
Biocompatibility of the titanium alloy plates are supported by the reference devices K180626 and K182718. Biocompatibility of the UHMWPE surgical sutures are supported by the reference devices K100006. Biocompatibility of the stainless steel of the guide wire are supported for the following test reports: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity and Materialmediated Pyrogenicity Testing according the FDA guidance entitled Use of International Standard ISO 10993-1,"Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" dated June 16, 2016 according to the device categorization and contacting profile. Pyrogenicity monitoring according to AAMI/ANSI ST72 meeting pyrogen limit specifications.
The subject devices are provided sterile and have shelf life of 3 years. Ethylene oxide sterilization validation was performed according to ISO 11135.
The performance of the subject devices compared with the predicate devices are demonstrated through mechanical testing. No clinical data were included in this submission.
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.