(27 days)
Not Found
No
The summary describes a mechanical implant system for fracture fixation and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is an intramedullary system for fracture fixation, which is a surgical implant rather than a therapeutic device that administers therapy or treatment.
No
The device, the MICRONAIL® Intramedullary Distal Radius System, is intended for "fixation of unstable distal radius fractures," indicating it is a therapeutic or surgical device, not a diagnostic one.
No
The device description explicitly states it consists of physical components (radial nail, cortical bone screws, buttress pins, and buttress screws) made from titanium alloy, indicating it is a hardware-based medical device.
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, or tissue) to provide information about a person's health.
- Device Description: The MICRONAIL® Intramedullary Distal Radius System is a system of implants (radial nail, screws, pins) made of titanium alloy. These are surgically implanted into the bone to fix fractures.
- Intended Use: The intended use is for the fixation of unstable distal radius fractures. This is a surgical procedure, not a diagnostic test performed on a sample.
- Lack of Diagnostic Function: The device itself does not perform any diagnostic testing on biological samples. It is a therapeutic device used to stabilize a fracture.
The information provided clearly describes a surgical implant system used for fracture fixation, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MICRONAIL® Intramedullary Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:
• Joint destruction and/or subluxation visible on x-ray;
- · Failed fracture fixation with or without bone graft;
- · Osteotomy and repair of distal radius malunion with or without bone graft;
- · Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone;
- · Comminuted articular fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with or with or with or without an external fixator.
Product codes
HSB
Device Description
The MICRONAIL™ Distal Radius System was cleared (K040938) as a system consisting of a radial nail, cortical bone screws, buttress pins, and buttress screws. All components are manufactured from titanium alloy, Ti 6Al-4V-ELI. Changes to the subject devices include changes made to the radial nail, buttress screws, and cortical bone screws and availability of sterile and non-sterile devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
distal radius
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
Mechanical testing, including Static Bending Strength, as well as FEA analysis has shown that the performance of the subject screw is statistically equivalent or greater than the predicate screw.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Incorporated Ms. Jeanine Redden Regulatory Affairs Director 1023 Cherry Road Memphis, Tennessee 38117
February 10, 2015
Re: K150073
Trade/Device Name: MICRONAIL® Distal Radius System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 8, 2015 Received: January 14, 2015
Dear Ms. Redden:
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Jeanine Redden
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/Resourcesfor You/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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K150073
Device Name MICRONAIL® Distal Radius System
Indications for Use (Describe)
The MICRONAL® Intramedulary Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:
• Joint destruction and/or subluxation visible on x-ray;
- · Failed fracture fixation with or without bone graft;
- · Osteotomy and repair of distal radius malunion with or without bone graft;
- · Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone;
- · Comminuted articular fractures of the articular surface, severely comminuted extra-articular fractures, and
fractures in which reduction has been lost following fixation with or with or with or without an external fixator.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Expiration Date: January 31, 2017 See PRA Statement on last page.
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K150073 Page 1 of 2
Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
901 867 9971 wmt.com
Image /page/4/Picture/4 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, to the left of the word "WRIGHT" in red, sans-serif font. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray, sans-serif font. The logo is clean and modern, with a focus on the company name and a tagline that emphasizes quality.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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 MICRONAIL™ Distal Radius System.
| 1. Submitted By: | Wright Medical Technology, Inc. 1023 Cherry Rd. Memphis, TN 38117 |
|---|---|
| Date: | February 9, 2015 |
| Contact Person: | Jeanine Redden Director, Regulatory Affairs Phone: 901.867.4522 Fax: 901.687.4190 jeanine.redden@wmt.com |
| 2. Proprietary Name: | MICRONAIL TM Distal Radius System |
| Common Name: | Intramedullary fixation rod |
| Classification Name and Reference: | 21 CFR 888.3020- Class II |
| Device Product Code, Device Panel: | HSB - Orthopedic |
3. Predicate Device:
K040938 Radial Nail System
Device Description 4.
The MICRONAIL™ Distal Radius System was cleared (K040938) as a system consisting of a radial nail, cortical bone screws, buttress pins, and buttress screws. All components are manufactured from titanium alloy, Ti 6Al-4V-ELI. Changes to the subject devices include changes made to the radial nail, buttress screws, and cortical bone screws and availability of sterile and non-sterile devices.
5
5. Intended Use
The MICRONAIL® Intramedullary Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:
- · Joint destruction and/or subluxation visible on x-ray;
- · Failed fracture fixation with or without bone graft;
- · Osteotomy and repair of distal radius malunion with or without bone graft;
- · Displaced or non-displaced fracture which may or may not involve angulation or fragmentation of bone;
- · Comminuted articular fractures, shearing fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.
Technological Characteristics Comparison 6.
The MICRONAIL™ Distal Radius System and the legally marketed predicate Radial Nail System have identical indications, utilize the same instrumentation, and are identical in material. Sterilization methods have been updated to reflect the addition of products that are provided sterile.
7. Substantial Equivalence- Non-Clinical Evidence
Mechanical testing, including Static Bending Strength, as well as FEA analysis has shown that the performance of the subject screw is statistically equivalent or greater than the predicate screw.
8. Substantial Equivalence- Clinical Evidence
N/A
9. Substantial Equivalence- Conclusions
The design characteristics of the subject devices 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 systems and are substantially equivalent.