MODIFICATION TO JET-X HA COATED HALF PINS

K033289 · Smith & Nephew, Inc. · JDW · Jan 13, 2004 · Orthopedic

Device Facts

• Record ID: K033289
• Device Name: MODIFICATION TO JET-X HA COATED HALF PINS
• Applicant: Smith & Nephew, Inc.
• Product Code: JDW · Orthopedic
• Decision Date: Jan 13, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Jet-X HA Coated Half Pin is a metallic bone fixation fastener used with external fixation systems. Device serves as a modification of previously cleared Jet-X Half Pin (K023921) to implement an alternate supplier for hydroxyapatite (HA) coating. Device functions as a mechanical fastener for bone stabilization in orthopedic procedures. Used by surgeons in clinical settings to provide structural support for fracture healing, deformity correction, or arthrodesis. No software or algorithmic components involved.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Metallic bone fixation fastener; hydroxyapatite (HA) coated. Principle of operation is mechanical bone fixation via external system. No software, electronics, or connectivity.

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 Half Pin (K023921)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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).

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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.

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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 [phone]. 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 [phone] or [phone] 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

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### 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