(27 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical external fixator system and does not mention any AI or ML components or functionalities.
Yes
The device is used for stabilizing fractures, fusions, and corrective osteotomies, which are therapeutic interventions.
No
The device is described as a fixator system for stabilizing fractures and lengthening bones, which are therapeutic functions, not diagnostic ones. Its purpose is to physically support and manipulate bone structures, not to identify or analyze medical conditions.
No
The device description clearly states it is a "Rail Fixator System," which is a hardware device used to stabilize bones. There is no mention of software as the primary or sole component.
Based on the provided information, the SIDEKICK™ Rail Fixator System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for stabilizing fractures, fusions, and corrective osteotomies of specific bones. This is a therapeutic and surgical purpose, not a diagnostic one performed on samples outside the body.
- Device Description: The description details a mechanical system for stabilizing and manipulating bones. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, tissue, or other biological samples, which are hallmarks of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SIDEKICK™ Rail Fixator System is a surgical implant/device used directly on the patient's body for treatment.
N/A
Intended Use / Indications for Use
The SIDEKICK™ Rail Fixator System is indicated for stabilizing various fractures including open and comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The SIDEKICK™ Rail Fixator System is a stable solution for fractures and for lengthening of small bones. The system allows precise, controlled compression/distraction and early weight bearing. The articulation pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures, or arthrodesis of the foot or hand.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
metacarpal, metatarsal, ulnar, and calcaneal bones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
FEB - 7 2008
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, this information serves as a Summary of Safety and Effectiveness for the use of the SIDEKICK™ Rail Fixator System.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | December 26, 2007 |
| Contact Person: | Peggy S. Rivers |
| Regulatory Affairs Specialist | |
| Proprietary Name: | SIDEKICK™ Rail Fixator System |
| Common Name: | External Fixation System |
| Classification Name and Reference: | Single/multiple component metallic bone fixation appliances and accessories -Class II per 21 CFR section 888.3030 |
| Device Product Code and Panel Code: | Orthopedics/87/KTT |
DEVICE INFORMATION
INTENDED USES/ INDICATIONS A.
The SIDEKICK™ Rail Fixator System is indicated for stabilizing various fractures including open and comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.
B. DEVICE DESCRIPTION
The SIDEKICK™ Rail Fixator System is a stable solution for fractures and for lengthening of small bones. The system allows precise, controlled compression/distraction and early weight bearing. The articulation pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures, or arthrodesis of the foot or hand.
1
Image /page/1/Picture/0 description: The image contains a sequence of alphanumeric characters that appear to be handwritten. The sequence starts with the letters 'KO', followed by the numbers '80071'. The characters are written in a dark ink, and the handwriting style is somewhat cursive.
SUBSTANTIAL EQUIVALENCE INFORMATION ﺰ
The indications for use of the SIDEKICK™ Rail Fixator System 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™ Rail Fixator system.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird-like figure.
Public Health Service
FEB -7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, INC % Ms. Peggy S. Rivers Regulatory Affairs Specialist 5677 Airline Road Arlington, TN 38002
Re: K080071 Trade/Device Name: Sidekick™ Rail Fixator 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: January 9, 2008 Received: January 11, 2008
Dear Ms. Rivers:
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 Amendonents, 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.
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 devire 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); good manufacturing practice requirements as set 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.
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Page 2 - Ms. Peggy S. Rivers
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Mikkelsen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: SIDEKICK™ Rail Fixator System
Indications For Use:
The SIDEKICK™ Rail Fixation System is indicated for stabilizing various fractures including open an/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar and calcaneal bones.
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
Barbara Mueller
an Division of General, Restorative, and Neurological Devices
510(k) Number K0810071