(72 days)
No
The summary describes a mechanical device (half pin) used in external fixation systems. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The modifications are related to the physical design and coating of the pin.
Yes
Explanation: The device is intended for fracture fixation, nonunion of long bones, limb lengthening, correction of deformity, and joint arthrodesis, all of which are therapeutic indications.
No
The device, the Jet-X HA Coated Half Pin, is described as intended for fracture fixation, limb lengthening, correction of deformities, and joint arthrodesis, which are therapeutic interventions rather than diagnostic ones.
No
The device description clearly states it is a "half pin" and describes modifications to threads and coating, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "fracture fixation," "limb lengthening," "correction of bony or soft tissue deformity," and "joint arthrodesis." These are all procedures performed on the body (in vivo), not tests performed on samples taken from the body (in vitro).
- Device Description: The description details a "half pin" used with an "external fixation system." This is a physical implant/device used to stabilize bones, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory tests.
Therefore, the Jet-X HA Coated Half Pin is a surgical implant/device used for orthopedic procedures, not an in vitro diagnostic device.
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 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.
Product codes
JDW
Device Description
The Jet-X Half Pin is a modification of the Jet-X TiN Coated Half Pin that was cleared for market under K023134. This submission design modifications to the threads and provides for a hydroxylapatite (HA) coated stainless steel half pin.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Jet-X
HA Coated Half Pins Special 510(k) Notification
page 1 of 1
510(k) Summary of Safety and Effectiveness Jet-X® Half Pins
| Submitted By: | Smith & Nephew, Inc.
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------|
| | FEB 05 2003 |
| Date: | November 22, 2002 |
| Contact Person: | David Henley
Senior Clinical/Regulatory Affairs Specialist
Tel: (901) 399-6487
Fax: (901) 398-5146 |
| Proprietary Name: | Jet-X Half Pins |
| Common Name: | Half Pins |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation fastener
21CFR888. 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 TiN Coated Half Pin that was cleared for market under K023134. This submission design modifications to the threads and provides for a hydroxylapatite (HA) coated stainless steel half pin.
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 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.
Technological Characteristics:
The principles of operation for the Jet-X Half Pin are identical to the Jet-X TiN Coated Half Pin. Both are half pins that are used with external fixation systems for fracture fixation (open and closed) and other indications listed above. The hydroxylapatite (HA) coating is the same coating currently used on Smith & Nephew's HA Global Taper Tapered (Synergy) Hip Stems (K970337). The Orthofix External Fixation Screw (K974186) marketed by Orthofix SRL also has a HA coating applied to the threaded area. The design and material of the Jet-X Half Pin has the same technological characteristics as one or more of the predicate devices.
Substantial Equivalence Information:
The intended use of the Jet-X Half Pin is identical to the Jet-X TiN Coated Half Pin. The Jet-X Half Pin shape and design are also very similar to the Jet-X TiN Coated Half Pin. The subject device is manufactured from the identical 316L stainless steel material as is used to manufacture the Jet-X TiN Coated Half Pin. The HA coating is identical to the coating used on Smith & Nephew's HA Global Taper Tapered (Synergy) Hip Stems (K970337). It is similar to the HA coating used on the Orthofix External Fixation Screw (K974186) marketed by Orthofix SRL.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be flowing into each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
FEB 0 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis. Tennessee 38116
Re: K023921
Trade/Device Name: Jet-X® HA Coated Half Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JDW Dated: January 15, 2003 Received: January 16, 2003
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
2
Page 2 - Mr. David Henley
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. 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,
e. Mark N. Millerson
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
i10(k) Number (if known):
Device Name: Jet-X® HA Coated Half Pin
ndications for Use:
l'he 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Milliken
-al, Restorative rvices and Neurologic
02392
510(k) Number
Prescription Use (Per 21 CFR 801.109)
Over-The Counter Use
(Optional Format 1-2-96)