(251 days)
No
The 510(k) summary describes a mechanical external fixation system and does not mention any AI or ML components or functionalities.
Yes
The device is described as an external open ring fixation system used to stabilize fractures, perform fusions, and correct bone deformities, which are all therapeutic interventions.
No
This device is an external plating system used for the treatment and stabilization of broken or deformed bones, and for bone fusions and corrections. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it is an "external open ring fixation system" and mentions "components," indicating it is a physical hardware device used for bone stabilization and correction. The performance studies also refer to "performance testing (ASTM F1541, and torque to failure testing)," which are tests typically performed on physical medical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Revolution External Plating System is described as an "external open ring fixation system" used to stabilize broken or deformed bones. It is applied to the body to provide structural support and facilitate healing.
- Intended Use: The intended uses listed all involve the treatment of bone fractures, fusions, and deformities within the body.
The device is a surgical implant/external fixation system, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones:
- Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures
- Fusions of the joints and bone (hand, foot, long-bone)
- Correction of bone or soft tissue deformities
- Correction of segmental or non-segmental bone, soft tissue defects or bone loss
- Neutralization of fractures stabilized with limited internal fixation
- Adult and Pediatric subgroups except newborns
Product codes
KTT
Device Description
The Revolution External Plating System is an external open ring fixation system to provide stability for long bone fractures, limb lengthening, and correction of bone deformities all at a distance from the operative focus. When used with other components, this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones (complex proximal and/or distal tibial fractures, hand, foot, long-bone)
Indicated Patient Age Range
Adult and Pediatric subgroups except newborns
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
Performance testing (ASTM F1541, and torque to failure testing) was completed to support the modifications to the system and demonstrate its substantial equivalence to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
May 30, 2024
New Standard Device DBA Metalogix % Danielle Besal Principal Consultant MRC Global 9085 E Mineral Circle Suite 110 Centennial, Colorado 80112
Re: K233025
Trade/Device Name: Revolution External Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: September 22, 2023 Received: September 22, 2023
Dear Danielle Besal:
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 (OS) 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.
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-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).
2
Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Lixin Liu-S" in a simple, sans-serif font. The text is black and appears to be against a white background. The name is likely a person's name, with "Lixin Liu" being the first and last name, and "-S" potentially being an initial or suffix.
Lixin Liu, PhD Assistant Director DHT6A: Division of Joint Arthroplasty 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
Revolution External Plating System
Indications for Use (Describe)
The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones:
- Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures
- · Fusions of the joints and bone (hand, foot, long-bone)
- · Correction of bone or soft tissue deformities
- · Correction of segmental or non-segmental bone, soft tissue defects or bone loss
- · Neutralization of fractures stabilized with limited internal fixation
- · Adult and Pediatric subgroups except newborns
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
Revolution External Plating System K233025 May 30, 2024
| Company: | New Standard Device dba Metalogix
4766 Research Dr
San Antonio, TX 78240 |
|--------------------|--------------------------------------------------------------------------------------------------------|
| Primary Contact: | Danielle Besal
Principal Consultant MRC Global
901.827.8670
Danielle.Besal@askmrcglobal.com |
| Company Contact: | Ben Coburn
CEO Metalogix
833.659.2019 |
| Trade Name: | Revolution External Plating System |
| Common Name: | External fixation system |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3030 Single/multiple component metallic bone fixation
appliances and accessories |
| Product Code: | KTT |
| Panel: | Orthopedic |
| Predicate Device: | K181630 Revolution External Plating System |
| Reference Device: | K152171 Orthofix TL-HEX True Lok Hexapod System |
Device Description:
The Revolution External Plating System is an external open ring fixation system to provide stability for long bone fractures, limb lengthening, and correction of bone deformities all at a distance from the operative focus. When used with other components, this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar, or condylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone.
Indications for Use:
The Revolution External Plating System is indicated for treatment of a variety of broken or deformed bones:
- Stabilizes open and/or unstable fracture of complex proximal and/or distal tibial fractures
- Fusions of the joints and bone (hand, foot, long-bone)
- Correction of bone or soft tissue deformities
- Correction of segmental or non-segmental bone, soft tissue defects or bone loss
- Neutralization of fractures stabilized with limited internal fixation
- Adult and pediatric subgroups except newborns
Substantial Equivalence Discussion:
The subject Revolution External Plating System is a modification to the predicate Revolution External Plating System (K181630) and includes design and material changes to individual system components and introduction of new welded tibial block constructs, and Z-post components. The subject system is similar in indications for use, materials, and design to the predicate system (K181630). Testing
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has demonstrated that performance of the subject devices is equivalent to that of the predicate and the reference device, and thus, the differences in geometry versus the predicate do not raise different questions of safety and effectiveness.
Performance Testing:
Performance testing (ASTM F1541, and torque to failure testing) was completed to support the modifications to the system and demonstrate its substantial equivalence to the predicate device.
Conclusion:
The subject Revolution External Plating System is substantially equivalent to the predicate Revolution External Plating System (K181630).