(29 days)
Jet-X Bar External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformity: correction of segmental bony or soft tissue defects; infected fractures or non-unions; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius.
Jet-X Bar Clamp and Pin Clamp - Non-magnetic/MR Safe components are for single use only.
External fixation devices, such as the Jet-X Bar Clamp and Pin Clamp - Non-Magnetic/MR Safe devices described herein, are specifically designed components to be used in the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Devices include a Jet-X Bar-to-Bar Clamp -Non-magnetic/MR Safe; a Jet-X Bar-to-Pin Clamp - Non-magnetic/MR Safe; and a Jet-X Bar-to-Ring Clamp - Non-magnetic/MR Safe. The metal alloys used in their manufacture are chosen to address a wide range of applications. These devices have been designed to allow for the appropriate amount of rigidity and stability. The devices described herein are made from non-magnetic materials and are intended for use in the MR environment.
The provided text is a 510(k) summary for a medical device (Jet-X® Bar Clamps and Pin Clamps - Non-magnetic/MR Safe) and does not contain information about acceptance criteria and a study proving those criteria were met for an AI/ML powered device.
This document describes a traditional medical device (external fixation accessories) and focuses on its substantial equivalence to predicate devices, material composition, intended use, and regulatory classification. It does not involve any artificial intelligence, machine learning, or software-driven diagnostic or therapeutic functions that would require the evaluation of performance metrics such as accuracy, sensitivity, or specificity against established ground truth.
Therefore, I cannot fulfill the request to provide the detailed information listed in the prompt (acceptance criteria table, sample sizes, expert qualifications, etc.) as that information is not present in the provided text.
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K 0423/2
510{k} Summary of Safety and Effectiveness Jet-X® Bar Clamps and Pin Clamps - Non-magnetic/MR Safe
| Submitted by: | Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116 |
|---|---|
| Date: | September 24, 2004 |
| Contact Person: | David HenleySenior Clinical / Regulatory Affairs Specialist |
| Proprietary Name: | Jet-X® Bar Clamps and Pin Clamps - Non-Magnetic/MR Safe |
| Common Name: | External Fixation Accessories |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation fastener,21 CFR 888.3030, Class II |
| Device Product Code and Panel Code: | KTT / Orthopedics / 87 |
Device Description:
External fixation devices, such as the Jet-X Bar Clamp and Pin Clamp - Non-Magnetic/MR Safe devices described herein, are specifically designed components to be used in the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Devices include a Jet-X Bar-to-Bar Clamp -Non-magnetic/MR Safe; a Jet-X Bar-to-Pin Clamp - Non-magnetic/MR Safe; and a Jet-X Bar-to-Ring Clamp - Non-magnetic/MR Safe. The metal alloys used in their manufacture are chosen to address a wide range of applications. These devices have been designed to allow for the appropriate amount of rigidity and stability. The devices described herein are made from non-magnetic materials and are intended for use in the MR environment.
Intended Use:
The devices described herein are intended to be used on adults or pediatic patients as required and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis or non-union of long bones; imb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius.
Technological Characteristics:
The principle of operation of these devices is identical to that of the predicates. There are no changes in intended use, performance specifications or method of operation. These non-magnetic/MR Safe devices utlize stainless steel, fitanium, and aluminum materials and technological characteristics that are very similar when compared to the predicate devices,
Substantial Equivalence Information:
Documentation is provided in this premarket notification that demonstrates that Jet-X Bar Clamp and Pin Clamp – Non-magnetic/MR Safe devices are substantially equivalent to other legally marketed devices.
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Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.
SEP 2 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116
Re: K042312
Trade/Device Name: Jet-X Bar Clamps and Pin Clamps - Non- magnetic / MR Safe Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: August 25, 2004 Received: August 26, 2004
Dear Mr. Henley:
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.
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 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 – Mr. David Henley
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ocglif maing of substantial equivalence of your device to a legally premarker hotification. The 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 IT you desire specific advice for Jour as 1) 594-4659. Also, please note the regulation entitled, Connect the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain Millsonaling of Yelereno to presensibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
Mark N. McKennon
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Indications for Use Statement Jet-X Bar Clamps and Pin Clamps - Non-magnetic/MR Safe
K042312 510(k) Number (if known):
Device Name: Jet-X Bar Clamps and Pin Clamps - Non-magnetic/MR Safe
Indications for Use:
jet-X Bar External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction of bony or soft tissue deformity: correction of segmental bony or soft tissue defects; infected fractures or non-unions; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius.
Jet-X Bar Clamp and Pin Clamp - Non-magnetic/MR Safe components are for single use only.
Prescription Use _ × (Per 21 CFR 801.109)
OR
Over-the-Counter Use (Optional Format 1-2-96)
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Musha N. Melkessia
Restorative.
510(k) Number K042312
§ 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.