(87 days)
Not Found
No
The description focuses on mechanical components and their function in external fixation, with no mention of AI/ML terms or capabilities.
Yes
The device is used to secure the foot and tibia and provides compression or distraction, which are therapeutic actions aimed at treating various foot pathologies and injuries.
No
The device description indicates it is an external fixation system used for compression or distraction in the foot and securng the tibia, suggesting a therapeutic or supportive function rather than diagnosing conditions. The 'Intended Use / Indications for Use' lists various surgical-related procedures (e.g., arthrodesis, trauma reconstruction) which are typically treated, not diagnosed, by such a device.
No
The device description explicitly states it uses "a series of pins and wires" and a "boot," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the SIDEKICK® EZ FRAME™ External Fixation System is a system of pins, wires, and a boot used for external fixation of the foot and tibia. This is a surgical device used directly on the patient's body for structural support and stabilization.
- Intended Use: The intended uses listed (arthrodesis, trauma, reconstruction) are all surgical procedures performed on the patient's body.
There is no mention of analyzing biological specimens or providing diagnostic information based on such analysis.
N/A
Intended Use / Indications for Use
- Triple arthrodesis
- Isolated rearfoot arthrodesis
- Midfoot arthrodesis
- Comminuted trauma
- Diabetic Charcot reconstruction
- Most foot pathology not requiring fixation above the ankle
Product codes (comma separated list FDA assigned to the subject device)
KTT, HTY, JEC
Device Description
The SIDEKICK® EZ FRAME™ External Fixation System uses a series of pins and wires for compression or distraction in the foot and uses a boot to secure the tibia. The system is adjustable to accommodate variations in patient anatomy. The SIDEKICK® EZ FRAME™ External Fixation System is compatible with the SIDEKICK® FREEDOM External Fixation System (K043289) components, and these components provide additional fixation options in the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, tibia, ankle
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)
Not Found
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.
K043289 E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT
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.
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
APR 0 5 2013
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 SIDEKICK® EZ FRAME™ External Fixation System.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
5677 Airline Road
Arlington, TN 38002 |
|------------------------------------|-------------------------------------------------------------------------------|
| Date: | January 4, 2013 |
| Contact Person: | Ryan Bormann
Regulatory Affairs Specialist II
(901) 867-4409 |
| (a)(2). Proprietary Name: | SIDEKICK® EZ FRAME™ External Fixation
System |
| Common Name: | External Fixation Device |
| Classification Name and Reference: | 21 CFR 888.3030 - Class II |
| Device Product Code, Device Panel: | KTT, Appliance, Fixation, Nail/Blade/Plate
Combination, Multiple Component |
| (a)(3). Predicate Device: | K043289 E-Z FRAME EXTERNAL SURGICAL
SUPPORT BOOT |
(a)(4). Device Description
The SIDEKICK® EZ FRAME™ External Fixation System uses a series of pins and wires for compression or distraction in the foot and uses a boot to secure the tibia. The system is adjustable to accommodate variations in patient anatomy. The SIDEKICK® EZ FRAME™ External Fixation System is compatible with the SIDEKICK® FREEDOM External Fixation System (K043289) components, and these components provide additional fixation options in the system.
(a)(5). INTENDED USE
- · Triple arthrodesis
- · Isolated rearfoot arthrodesis
- · Midfoot arthrodesis
- · Comminuted trauma
- · Diabetic Charcot reconstruction
- · Most foot pathology not requiring fixation above the ankle
1
(a)(6). Technological Characteristics Comparison
The subject device operates in the same method as the predicate.
(b)(1). Substantial Equivalence – Non-Clinical Evidence ·
- Through mechanical component analysis and comparison the subject system does not represent a new worst-case.
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject device system can be expected to perform at least as well as the predicate systems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Letter dated: April 5, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Mr. Ryan Bormann Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K130044
Trade/Device Name: SIDEKICK® EZ FRAME™ External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: KTT, HTY, JEC Dated: January 4, 2013 Received: January 8, 2013
Dear Mr. Bormann:
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 (reporting of medical
3
Page 2 - Mr. Ryan Bormann
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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
4
Indications for Use
510(k) Number (if known): K130044
Device Name: SIDEKICK® EZ FRAME™ External Fixation System
Indications For Use:
- Triple arthrodesis .
- lsolated rearfoot arthrodesis .
- Midfoot arthrodesis
- . Comminuted trauma
- . Diabetic Charcot reconstruction
- Most foot pathology not requiring fixation above the ankle .
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Casey LTHanley Division Devices
Concurrence of CDRH, Office of Device Evaluation (ODE) 1 of 1