(265 days)
Not Found
No
The summary describes a mechanical external fixator and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for stabilizing fractures, fusions, and corrective osteotomies, which are therapeutic interventions.
No
The device description indicates it is a surgical tool used for stabilizing fractures, fusions, and corrective osteotomies, not for diagnosing conditions.
No
The device description clearly describes a physical external fixator, which is a hardware device used to stabilize bones. It is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Rx-Fix external fixator is a mechanical device used to stabilize bones externally. It is applied directly to the patient's body to support and align fractures.
- Intended Use: The intended use is to stabilize fractures, fusions, and corrective osteotomies. This is a therapeutic and structural function, not a diagnostic one based on analyzing bodily samples.
The information provided clearly describes a surgical implant/device used for structural support and stabilization of bones, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Rx-Fix external fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with/ length discrepancies, fusions and corrective osteotomies. The selection of the appropriate type of fixator is left to the discretion of the surgeon, according to the type of fracture and patient's anatomy.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The subject RX-FIX Minirail External Fixator is a stable solution for fractures and for lengthening of small bones. It is used for comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. The RX-FIX allows for variable pin placement in transverse and frontal planes to simplify external fixation applications on several surgical procedures including: fusions, corrective osteotomies, and fracture fixation. The pin clamp allows for both compression and distraction of the pins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot or hand
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)
Substantial Equivalence Non-Clinical Evidence N/A
Substantial Equivalence Clinical Evidence N/A
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.
K051017: R-X-FIX Eternal Fixator
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2015
Wright Medical Technology, Incorporated Leslie Fitch, Ph.D. Senior Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K150640
Trade/Device Name: RX-FIX Mini Rail External Fixator 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: October 23, 2015 Received: October 26, 2015
Dear Dr. Fitch:
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. 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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150640
Device Name RX-FIX Mini Rail External Fixator
Indications for Use (Describe)
The Rx-Fix external fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies. The selection of the appropriate type of fixator is left to the discretion of the type of fracture and patient's and patient's anatomy.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Headquarters Wright Medical Technology, Inc.
023 Cherry Road Memphis, TN 3811
901 867 997
wmt.com
510(K) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the RX-FIX Minirail External Fixator.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|------------------------------------|------------------------------------------------------------------------------------------------------------|
| Date: | March 6, 2015 |
| Contact Person: | Leslie Fitch, PhD
Senior Regulatory Affairs Specialist
Office: (901) 867-4120
Fax: (901) 867-4190 |
| (a)(2). Proprietary Name: | RX-FIX Minirail External Fixator |
| Common Name: | External Fixation System |
| Classification Name and Reference: | 21 CFR 888.3030 – Class II |
| Device Product Code, Device Panel: | KTT, Orthopedic |
| (a)(3). Predicate Devices: | K051017: R-X-FIX Eternal Fixator |
(a)(4). Device Description
The subject RX-FIX Minirail External Fixator is a stable solution for fractures and for lengthening of small bones. It is used for comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. The RX-FIX allows for variable pin placement in transverse and frontal planes to simplify external fixation applications on several surgical procedures including: fusions, corrective osteotomies, and fracture fixation. The pin clamp allows for both compression and distraction of the pins.
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(a)(5). Intended Use
The Rx-Fix external fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with/ length discrepancies, fusions and corrective osteotomies. The selection of the appropriate type of fixator is left to the discretion of the surgeon, according to the type of fracture and patient's anatomy.
(a)(6). Technological Characteristics Comparison
RX-FIX Minirail External Fixator System is technologically substantially equivalent to predicate devices in material and design.
- (b)(1). Substantial Equivalence Non-Clinical Evidence N/A
- (b)(2). Substantial Equivalence Clinical Evidence N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k). the subject devices can be expected to perform at least as well as the predicate device.