(343 days)
Not Found
No
The device description focuses on mechanical components and their function in stabilizing bones. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies are mechanical tests, not studies evaluating algorithmic performance.
Yes
The device is used to stabilize broken or deformed bones, facilitate fusions of joints and bones, and correct deformities, which are all therapeutic interventions for medical conditions.
No.
The "Revolution External Plating System" is a device used for stabilizing bones and correcting deformities, and its indications for use and device description do not involve diagnosing any medical conditions. It is a treatment device, not a diagnostic one.
No
The device description explicitly details physical components such as plates, struts, half-pins, and wires, which are hardware used for external fixation.
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 taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Revolution External Plating System is a mechanical device used to stabilize and correct broken or deformed bones. It is surgically implanted or attached externally to the patient's limb. It does not analyze any biological samples.
The device's function is entirely focused on providing structural support and facilitating the healing or correction of bone issues directly on the patient's body.
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 (comma separated list FDA assigned to the subject device)
KTT
Device Description
Revolution 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.
A plating system consists of a stacked welded plate module and a footplate. These two plates are connected by four super-struts attached by the surgeon to give the best support for the patient. Once assembled, the module is attached to the patient's limb with half-pins or wires. The halfpins are threaded pins with a buttress thread form. Half pins come in three sizes, 4mm, 5mm, and 6mm. Half pins comes in 215mm overall length, but various thread lengths to encompass the size of the bone. Wires come In 1.8mm in diameter and come in 400mm overall lengths. They're meant for traction to the bone. These are inserted through or to the bone and attached to the frame to create a stable construction patient's limb thereby allowing the surgeon to correct or repair the patient's indications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones (hand, foot, long-bone), tibial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following mechanical tests were completed on the subject device per ASTM F1541:
- Connector static axial grip testing
- Connector static torsion grip testing
- Ring static in-plane compression testing
- Strut static axial compression testing
- Construct dynamic axial compression testing
The results of this non-clinical testing show that the strength of the Revolution External Plating System is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K071394, K053472, K152171, K970748, K112218, K031181, K140463
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
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May 29, 2019
New Standard Device DBA Metalogix % Nathan Wright Engineer & Regulatory Specialist Empirical Consulting LLC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K181630
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: April 25, 2019 Received: April 29, 2019
Dear Nathan Wright:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181630
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) |
|---|
| Research Use (Part 21 CFR 821 Subpart B) For The Contact Lens (21 CFR 821 Subpart C) |
| > Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
| Submitter's Name: | New Standard Device DBA Metalogix |
|---|---|
| Submitter's Address: | 4766 Research Drive |
| San Antonio Texas 78240 | |
| USA | |
| Submitter's Telephone: | (210)492-1511 |
| Contact Person: | Nathan Wright, MS |
| Empirical Consulting LLC | |
| 719-351-0248 | |
| Date Summary was Prepared: | 18 Jun 2018 |
| Trade or Proprietary Name: | Revolution External Plating System |
| Common or Usual Name: | External fixator |
| Classification: | Class II per 21 CFR §888.3030 Device Classification |
| Product Code: | KTT |
| Classification Panel: | Orthopedic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
Revolution 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
The indications for use for the Revolution External Plating System are similar to that of the predicate devices.
TECHNOLOGICAL CHARACTERISTICS
Revolution 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.
4
A plating system consists of a stacked welded plate module and a footplate. These two plates are connected by four super-struts attached by the surgeon to give the best support for the patient. Once assembled, the module is attached to the patient's limb with half-pins or wires. The halfpins are threaded pins with a buttress thread form. Half pins come in three sizes, 4mm, 5mm, and 6mm. Half pins comes in 215mm overall length, but various thread lengths to encompass the size of the bone. Wires come In 1.8mm in diameter and come in 400mm overall lengths. They're meant for traction to the bone. These are inserted through or to the bone and attached to the frame to create a stable construction patient's limb thereby allowing the surgeon to correct or repair the patient's indications.
When used with other components this device stabilizes open and/or unstable fractures of long bones including intracapsular, intertrochanteric, supracondylar. It is also used for joint fusions and limb lengthening of deformity corrections which involve cutting the bone. Revolution External Plating System is made from material that conforms to ASTM standards. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar between the subject and predicates:
- . Indications for Use
- . Materials of manufacture
- Structural support mechanism ●
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K071394 | SBI RingFIX™ System | Small Bone Innovations | Primary |
| K053472 | Hoffmann® II MRI External | ||
| Fixation System | Howmedical | ||
| Osteonics Corp | Secondary | ||
| K152171 | Orthofix TL-HEX True Lok | ||
| Hexapod System (TL-HEX) | Orthofix Srl | Secondary | |
| K970748 | Taylor Spatial Frame External | ||
| Fixation System | Smith & | ||
| Nephew Inc. | Secondary | ||
| K112218 | Ace-Fischer® External Fixation | ||
| System | DePuy | ||
| Orthopaedics, | |||
| Inc. | Secondary | ||
| K031181 | External Fixation Systems | Smith & | |
| Nephew, Inc. | Secondary | ||
| K140463 | Integra External Fixation System | Ascension | |
| Orthopedics | Secondary |
| Table 5-1 Predicate Devices |
|---|
| ----------------------------- |
PERFORMANCE DATA
The following mechanical tests were completed on the subject device per ASTM F1541:
5
- Connector static axial grip testing ●
- Connector static torsion grip testing .
- Ring static in-plane compression testing .
- Strut static axial compression testing ●
- Construct dynamic axial compression testing ●
The results of this non-clinical testing show that the strength of the Revolution External Plating System is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Revolution External Plating System is substantially equivalent to the predicate device.