K Number
K042312
Device Name
JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE
Date Cleared
2004-09-24

(29 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

Not Found

No
The summary describes a mechanical external fixation system and does not mention any software, algorithms, or AI/ML capabilities.

Yes
The device is described as an external fixation system used for the management of bone fractures, post-traumatic joint contracture, limb lengthening, and various other orthopedic conditions. These applications are therapeutic in nature, aiming to treat or alleviate a medical condition.

No

The device is an external fixation system used for treating bone fractures and deformities, not for diagnosing conditions.

No

The device description explicitly states it includes physical components made from metal alloys (clamps) used in orthopedic surgery, which are hardware.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
  • Device Description and Intended Use: The description and intended use of the Jet-X Bar External Fixation System clearly state that it is a device used directly on the human body for the purpose of fixing fractures, correcting deformities, and stabilizing bones. This is an in vivo application, not an in vitro one.

The device is a surgical implant/external fixation system, not a diagnostic test performed on bodily fluids or tissues.

N/A

Intended Use / Indications for 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.

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.

Product codes

KTT

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults or pediatric patients

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)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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 Division
1450 Brooks Road
Memphis, TN 38116 |
|-------------------------------------|---------------------------------------------------------------------------------------|
| Date: | September 24, 2004 |
| Contact Person: | David Henley
Senior 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.

1

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.

2

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

3

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