(91 days)
Not Found
No
The summary describes a mechanical device (half pin) and a change in the supplier of its coating. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is used for fracture fixation, correction of bony/soft tissue deformity, limb lengthening, and joint arthrodesis, which are all therapeutic interventions.
No
The device is described as a "Half Pin" intended for "fracture fixation," "limb lengthening," and "correction of bony or soft tissue deformity," which are therapeutic and reconstructive uses, not diagnostic.
No
The device description clearly states it is a "Half Pin," which is a physical hardware component used in external fixation systems. The submission focuses on a modification related to the coating of this physical pin.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fracture fixation," "limb lengthening," "correction of bony or soft tissue deformity," and "joint arthrodesis." These are all surgical procedures performed directly on the patient's body.
- Device Description: The device is described as a "Half Pin" used with an "external fixation system." This is a physical implant/device used in surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device is a surgical implant/device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Jet-X Half Pin is intended to be used with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or nonumon of long bones; limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.
Product codes
JDW
Device Description
The Jet-X Half Pin is a modification of the Jet-X Half Pin that was cleared for market under K023921. This submission describes measures taken to implement an alternate supplier for application of the hydroxyapatite (HA) coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
JAN 1 3 2004
510(k) Summary of Safety and Effectiveness Jet-X® Half Pins
K033289
page 1 of 1
Smith & Nephew, Inc. Submitted By: Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 October 10, 2003 Date: David Henley Contact Person: Senior Clinical/Regulatory Affairs Specialist Tel: (901) 399-6487 Fax: (901) 398-5146 Jet-X Half Pins Half Pins
Proprietary Name:
Common Name:
Classification Name and Reference:
Smooth or threaded metallic bone fixation fastener, 21 CFR 888.3040, Class II
Device Product Code and Panel Code:
JDW/Orthopedics/87
Device Description:
The Jet-X Half Pin is a modification of the Jet-X Half Pin that was cleared for market under K023921. This submission describes measures taken to implement an alternate supplier for application of the hydroxyapatite (HA) coating.
Intended Use:
The Jet-X Half Pin is intended to be used with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or nonumon of long bones; limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.
Technological Characteristics:
The principles of operation for the Jet-X Half Pin are identical to the Jet-X Half Pin cleared under K023921. Both are half pins that are used with external fixation systems for fracture fixation (open and closed) and other indications listed above. The hydroxyapatite (HA) coating applied to the subject device is equivalent to the HA coating currently used on Smith & Nephew's Jet-X Half Pin (K023921). The design and material used in the Jet-X Half Pin has the same technological characteristics as one or more of the predicate devices.
Substantial Equivalence Information:
The dimensional characteristics, design, material type, principle of operation, indications for use and intended use of the subject Jet-X Half Pin are identical to the Jet-X Half Pin cleared under K023921. The HA coating is identical to the coating used on Smith & Nephew's Jet-X Half Pin (K023921).
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2004
Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K033289
Trade/Device Name: Jet-X® HA Coated Half Pin Regulation Number: 21 CFR 888.3040 Regulation Names: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: JDW Dated: December 12, 2003 Received: December 15, 2003
Dear Mr. Henley:
Wc have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your because the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated to togens and the Medical Device Amendments, or to connineres proct to they 20, 10, 10, 10, 10, 10, 10, 2017, 10, 10, 10, 10, 10, 10, 10, 10, 1 devices mat have been recuire approval of a premarket approval application (PMA). and Costicule rear (110.) that the device, subject to the general controls provisions of the Act. The r ou may, merelore, manel of the Act include requirements for annual registration, listing of general controls provincies 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 If your device to such additional controls. Existing major regulations alfecting your device can may be subject to back as a 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 docs not mean r lease of actived that in that your device complies with other requirements of the Act that I Dr Has/Intatutes and regulations administered by other Federal agencies. You must (n uny i vith all the Act's requirements, including, but not limited to: registration and listing (21 CHR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic form in the quiation 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 with anow you to begin mainening of substantial equivalence of your device to a legally prematics notification. The first 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), plcase If you desire specific advice for your as 11 (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your responser 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. Wilkerson
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
Indications for Use Statement Jet-X® HA Coated Half Pin
510(k) Number (if known): K033289
Device Name: Jet-X® HA Coated Half Pin
Indications for Use:
The Jet-X HA Coated Half Pin is intended to be used with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or nonunion of long bones; limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINF-CONTINUE ON ANOTHER PAGE IF NEFDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
h Mark N Milliman
Division of General Restorative and Neurological Devic
logical Data
K033 284