JET-X HA COATED HALF PINS

K023921 · Smith & Nephew, Inc. · JDW · Feb 5, 2003 · Orthopedic

Device Facts

• Record ID: K023921
• Device Name: JET-X HA COATED HALF PINS
• Applicant: Smith & Nephew, Inc.
• Product Code: JDW · Orthopedic
• Decision Date: Feb 5, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Jet-X HA Coated Half Pin is a metallic bone fixation fastener used with external fixation systems. Device consists of 316L stainless steel pin with hydroxylapatite (HA) coating on threaded area. Used by orthopedic surgeons in clinical settings for fracture stabilization, deformity correction, and arthrodesis. HA coating promotes osseointegration. Device is a modification of previously cleared Jet-X TiN Coated Half Pin; design changes involve thread modifications and addition of HA coating. Operates as a mechanical fastener to provide structural support to bone segments during healing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

316L stainless steel half pin with hydroxylapatite (HA) coating. Mechanical bone fixation fastener. Class II device per 21 CFR 888.3040.

Indications for Use

Indicated for patients requiring external fixation for fracture fixation (open/closed), pseudoarthrosis, nonunion of long bones, limb lengthening, correction of bony/soft tissue deformity, correction of segmental bony/soft tissue defects, and joint arthrodesis.

Regulatory Classification

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.

Predicate Devices

• Jet-X TiN Coated Half Pin (K023134)

Reference Devices

• HA Global Taper Tapered (Synergy) Hip Stems (K970337)
• Orthofix External Fixation Screw (K974186)

Submission Summary (Full Text)

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**Jet-X**
HA Coated Half Pins Special 510(k) Notification

page 1 of 1

K023921

# 510(k) Summary of Safety and Effectiveness Jet-X® Half Pins

| Submitted By: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 Brooks Road<br>Memphis, TN 38116 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------|
| | FEB 05 2003 |
| Date: | November 22, 2002 |
| Contact Person: | David Henley<br>Senior Clinical/Regulatory Affairs Specialist<br>Tel: [phone]<br>Fax: [phone] |
| Proprietary Name: | Jet-X Half Pins |
| Common Name: | Half Pins |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation fastener<br>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.

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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 [phone]. 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 [phone] or [phone] 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)