(142 days)
Not Found
No
The summary describes a mechanical external fixator system and does not mention any AI or ML components or functionalities.
Yes
The device is used for fracture fixation, limb lengthening, and correction of deformities in long bones, which are all therapeutic purposes.
No
The device is described as a "Circular Fixator System" used for orthopedic applications like fracture fixation, limb lengthening, and deformity correction. Its function involves changing physical position or orientation to correct deformities, rather than diagnosing conditions.
No
The device description clearly describes a physical medical device (a circular fixator system with struts and hinges) used for fracture fixation and deformity correction. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical fixation and correction of bone and soft tissue issues in living patients. This is a therapeutic and structural function, not a diagnostic one performed on samples outside the body.
- Device Description: The description details a mechanical system of struts and hinges used to manipulate bone and tissue position. This aligns with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SIDEKICK® Circular Fixator System does not fit this description.
N/A
Intended Use / Indications for Use
The SIDEKICK® Circular Fixator System: Struts and Hinges and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The SIDEKICK® Circular Fixator System: Struts and Hinges is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The SIDEKICK® Circular Fixator System: Struts and Hinges is a dynamic frame that can change position or orientation from the beginning of treatment to the end of treatment for correcting deformities in soft tissue or bone. The system allows precise, controlled compression/distraction. The hinges are used to create a point of rotation and/or angulation between levels of ring fixation on the frame. The rotation/angulation of the struts is used as compressors/distractors and which provide gradual or acute movement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all long bones including: tibia, fibula, femur, humerus, radius and ulna.
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 was shown through static compressive stress testing. The results of the test show that the subject SIDEKICK® Circular Fixator System: Struts and Hinges can be expected to perform at least as well as the legally marketed predicate R & R External. Fixation (Ring Fixator).
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.
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
JUN 1 0 2010
i
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 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the SIDEKICK® Circular Fixator System: Struts and Hinges.
| A.1. Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd
Arlington, TN 38002 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Date: | April 23, 2010 |
| Contact Person: | Megan McCagh
Regulatory Affairs Specialist
(901) 867-4120 |
| A.2. Proprietary Name: | SIDEKICK® Circular Fixator System: Struts
and Hinges |
| Common Name: | External Fixation System |
| Device Classification Regulation: | Single/multiple component metallic bone fixation
appliances and accessories -Class II per 21 CFR
section 888.3030 |
| Device Product Code & Panel: | Orthopedics/87/KTT |
| A.3. Predicate Device: | R & R External Fixation (Ring Fixator) (K052005) |
A.4. Device Description
The SIDEKICK® Circular Fixator System: Struts and Hinges is a dynamic frame that can change position or orientation from the beginning of treatment to the end of treatment for correcting deformities in soft tissue or bone. The system allows precise, controlled compression/distraction. The hinges are used to create a point of rotation and/or angulation between levels of ring fixation on the frame. The rotation/angulation of the struts is used as compressors/distractors and which provide gradual or acute movement.
A.5. Intended Use
The SIDEKICK® Circular Fixator System: Struts and Hinges and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The SIDEKICK® Circular Fixator System: Struts and Hinges is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
1
A.6. Technological Characteristics Comparison
The subject SIDEKICK® Circular Fixator System: Struts and Hinges and the legally marketed predicate R & R External Fixation (Ring Fixator) have the same indications, are used at the same anatomical sites, and are both multi-piece designs:
The subject SIDEKICK® Circular Fixator System: Struts and Hinges differs from the legally marketed predicate R & R External Fixation (Ring Fixator) in the number of axes of rotation, material and type of bridge element.
B.1. Substantial Equivalence - Non-Clinical Evidence
Substantial equivalence was shown through static compressive stress testing. The results of the test show that the subject SIDEKICK® Circular Fixator System: Struts and Hinges can be expected to perform at least as well as the legally marketed predicate R & R External. Fixation (Ring Fixator).
The safety and effectiveness of the SIDEKICK® Circular Fixator System: Struts and Hinges is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification.
B.2. Substantial Equivalence - Clinical Evidence
N/A
B.3. Substantial Equivalence - Conclusions
The indications for use of the SIDEKICK® Circular Fixator System: Struts and Hinges are identical to the predicate device. The design features and materials of the subject device are substantially equivalent to those of the predicate device. The substantial equivalence information, materials information, and analysis data provided within this Premarket Notification adequately supports the safety and effectiveness of the SIDEKICK® Circular Fixator System: Struts and Hinges.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Wright-Medical Technology, Inc. . c/o Ms. Megan McCagh Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
JUN 1 0 2010
Re: K100137
Trade/Device Name: SIDEKICK® Circular Fixator System: Struts and Hinges 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: May 10, 2010 Received: May 13, 2010
Dear Ms. McCagh:
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 such 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
3
Page 2 – Ms. Megan McCagh
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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/CDRH/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Barbara Muchm
Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K (00)37
Device Name: SIDEKICK® Circular Fixator System: Struts and Hinges
Indications For Use:
The SIDEKICK® Circular Fixator System: Struts and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction or bony or soft tissue defonnities, and correction of segmental or nonsegmental bony or soft tissue defects. The SIDEKICK® Circular Fixator System: Struts and Hinges is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 of 1
Omitte
(Division Sign Off) for nxm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100137