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 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.

AI/ML Overview

This 510(k) submission (K033289) for the Jet-X® Half Pins describes a modification to an already cleared device (K023921), specifically related to an alternate supplier for the hydroxyapatite (HA) coating. This type of submission generally relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials for performance acceptance criteria. Therefore, the information typically found in a study proving acceptance criteria for new device performance (like accuracy, sensitivity, specificity, etc.) is not present in this document.

The document emphasizes that the modified device has identical technological characteristics, design, material type, principle of operation, indications for use, and intended use to the predicate device, with the only change being the HA coating supplier. The new HA coating is stated to be equivalent to the coating used on the predicate.

Given this context, I will address the requested points based on what is available in the provided text, and explicitly state when information is not present due to the nature of this type of 510(k) submission.

Acceptance Criteria and Device Performance Study (Missing/Not Applicable for this Submission Type)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document
(Typically would include mechanical properties, biocompatibility, coating adhesion, etc. for a medical device of this type if it were a novel device or a significant redesign requiring new testing.)	(Performance data from specific tests proving the device meets the criteria would be listed here.)

Explanation: This 510(k) is for a modification (change in HA coating supplier) to an already cleared device, not a new device. The acceptance criteria for the original device would have been established and met in K023921. For this submission, the "acceptance criteria" is primarily the demonstration of substantial equivalence to the predicate device, particularly regarding the alternate HA coating's equivalence. The document doesn't detail performance metrics or specific test results for the modified device, but rather asserts its equivalence to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable / Not specified. No new clinical or performance testing on a "test set" is detailed in this 510(k) summary for the modified device. The submission relies on affirming equivalence.
Data Provenance: Not applicable. No new data from a test set is provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable / Not specified. This type of submission, focusing on material/supplier change for an orthopedic implant, does not involve clinical "ground truth" establishment by medical experts in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an orthopedic implant with a HA coating, not an AI-assisted diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is an orthopedic implant, not an algorithm.

7. Type of Ground Truth Used

Not applicable. For this type of submission, "ground truth" in the diagnostic sense is not relevant. The substantial equivalence argument relies on comparing the modified device's characteristics (materials, design, function, HA coating properties) to the predicate device, not on diagnostic accuracy against a clinical reference standard.

8. Sample Size for the Training Set

Not applicable. This is an orthopedic implant, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of the Study (as described in the 510(k) document):

The "study" presented in this 510(k) is not a clinical trial or performance study in the traditional sense. It's a comparative analysis demonstrating substantial equivalence to a predicate device.

Objective: To demonstrate that the Jet-X Half Pin with an alternate hydroxyapatite (HA) coating supplier is substantially equivalent to the currently marketed Jet-X Half Pin (cleared under K023921).
Methodology: The submission asserts that:
- 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 predicate device (K023921).
- 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).
"Results" / Conclusion: The FDA reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This indicates that the claim of equivalence, including the HA coating, was accepted by the FDA based on the provided documentation (which is not fully contained in this summary).

Key Takeaway: This 510(k) focuses on demonstrating that a manufacturing change (alternate HA coating supplier) does not alter the fundamental safety and effectiveness profile such that the device is no longer substantially equivalent to its predicate. It does not involve de novo clinical performance testing with human experts or AI algorithms.

Summary

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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: (901) 399-6487 Fax: (901) 398-5146 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:

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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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:

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

Regulation Number and Section

§ 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.