(19 days)
No
The summary describes a mechanical device (a half pin for external fixation) and makes no mention of AI or ML.
Yes
The device is used for fracture fixation, pseudoarthrosis or nonunion of long bones, limb lengthening, correction of deformities, and joint arthrodesis, all of which are considered therapeutic interventions.
No
Explanation: The device is an orthopedic implant (half pin) used for fracture fixation and limb lengthening. Its intended uses are therapeutic, not diagnostic.
No
The device description explicitly states it is a "half pin," which is a physical hardware component used in external fixation systems. It is a modification of a previously cleared hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used externally for fracture fixation, limb lengthening, deformity correction, and joint arthrodesis. These are all procedures performed on the body, not on samples taken from the body.
- Device Description: The device is described as a "half pin" used with an "external fixation system." This further reinforces its use as a physical implant/component for external support and manipulation of bones.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Jet-X TiN 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.
Product codes
JDW
Device Description
The Jet-X TiN Coated Half Pin is a modification of the Hex-Fix Half Pin that was cleared for market under K953397. This submission provides for a titanium nitride (TiN) 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 (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
K023/34
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510(k) Summary of Safety and Effectiveness Jet-X® TiN Coated Half Pins
| Submitted By: | Smith & Nephew, Inc.
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 | OCT 0 9 2002 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------|
| Date: | September 19, 2002 | |
| Contact Person: | David Henley
Senior Clinical/Regulatory Affairs Specialist
Tel: (901) 399-6487
Fax: (901) 398-5146 | |
| Proprietary Name: | Jet-X TiN Coated 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: | Orthopedics/87 | |
Device Description:
The Jet-X TiN Coated Half Pin is a modification of the Hex-Fix Half Pin that was cleared for market under K953397. This submission provides for a titanium nitride (TiN) coated stainless steel half pin.
Intended Use:
The Jet-X TiN 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.
Technological Characteristics:
The principles of operation for the Jet-X TiN Coated Half Pin are identical to the Hex-Fix Half Pin and the Richards Titanium 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 titanium nitride (TiN) coating is a similar coating currently used on the B-P Extended Collar Femoral Stem Prostheses marketed by Endotec, Inc. and on the Sherlock Threaded Suture Anchor marketed by Doctor's Research Group. Inc. The design and material of the Jet-X TiN Coated 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 TiN Coated Half Pin is identical to the half pin predicate devices. The Jet-X TiN Coated Half Pin shape and design are identical to the Hex-Fix and Richards Half Pin predicate devices. The device is manufactured from the identical material, 316L stainless steel, as the Hex-Fix Half Pin. The titanium nitride (TiN) coating is a similar coating used on the B-P Acetabular Component System and Sherlock Threaded Suture Anchor predicate devices.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
OCT 0 9 2002
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: K023134 Trade/Device Name: Jet-X™ TiN 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: September 19, 2002 Received: September 20, 2002
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) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, 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,
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
Jet-X® TiN Coated Half Pins Special 510(k) Notification
page loft
Indications for Use Statement Jet-X® TiN Coated Half Pin
510(k) Number (if known): K023134
Device Name: Jet-X TiN Coated Half Pin
Indications for Use:
The Jet-X TiN 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 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)
ಕ Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Stup Rurda
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number KD23134