(72 days)
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.
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.
The provided text describes a 510(k) submission for the "Jet-X HA Coated Half Pins," which is a rigid implant and does not involve AI or algorithms, nor does it present any studies involving device performance data against acceptance criteria in the manner typically seen for diagnostic or AI-driven medical devices.
Therefore, I cannot extract the requested information as it is not present in the provided document. The document focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use for regulatory clearance, rather than presenting a performance study with acceptance criteria.
Response:
The provided document describes a 510(k) submission for the "Jet-X HA Coated Half Pins," which is a medical device for bone fixation. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with specific acceptance criteria and reported device performance in the context of an AI or diagnostic device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in studies for AI-driven or diagnostic devices, is not available in the provided text.
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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 Division1450 Brooks RoadMemphis, TN 38116 |
|---|---|
| FEB 05 2003 | |
| Date: | November 22, 2002 |
| Contact Person: | David HenleySenior Clinical/Regulatory Affairs SpecialistTel: (901) 399-6487Fax: (901) 398-5146 |
| Proprietary Name: | Jet-X Half Pins |
| Common Name: | Half Pins |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation fastener21CFR888. 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.
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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
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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
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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)
§ 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.