The Hansson™ Pin System is intended for use in the temporary stabilization of types of fractures of the proximal femur. The subject device is indicated for fixation of proximal femoral fractures including but not limited to:

Intracapsular fractures of the femoral neck such as Transcervical and Subcapital Neck . Fractures
Basal Neck Fractures .
Slipped Capital Femoral Epiphysis (in pediatric patients) .

Device Description

The Hansson" Pin is a hip fracture system designed to treat various types of fractures of the proximal femur. This premarket notification is a line extension to modify the existing Hansson™ Pin System, which was cleared via K964893. The indications for use are being expanded to include additional types of proximal femoral fractures. Also, several dimension changes have been made to the predicate device's outer sleeve to improve the deployment and removal of the inner pin. In addition, the Hansson" Pin will also be fabricated from Titanium Alloy and an end cap will be added to the product line.

AI/ML Overview

This document is a 510(k) premarket notification for the Hansson™ Pin System, a hip fracture fixation device. The notification describes a line extension to modify the existing system, expanding its indications for use and making minor design changes.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The provided 510(k) summary does not contain acceptance criteria or performance data from a study. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, meaning they show the new device is as safe and effective as a legally marketed device, often through
comparison of technological characteristics or non-clinical performance data (e.g., mechanical testing). This particular document focuses on expanding indications and design changes, and relies on the substantial equivalence to the previously cleared Hansson Pin System (K964893) and the ASNIS II & III Cannulated Bone Screws.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

There is no information provided in this document regarding a test set sample size or data provenance for a study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

There is no information provided about experts, ground truth, or a test set in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

There is no information provided about an adjudication method or a test set in this document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This document describes a medical device (a pin system for hip fracture fixation), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This document describes a medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Since no study with a "test set" is described, there is no information provided regarding the type of ground truth used. The 510(k) process for devices like this typically relies on established engineering principles, biocompatibility testing, mechanical testing (e.g., fatigue, tensile strength), and comparison to predicate devices, rather than clinical ground truth from human data in the way an AI diagnostic would.

8. The sample size for the training set

There is no information provided about a training set sample size, as this document does not describe the development or validation of an algorithm or AI model.

9. How the ground truth for the training set was established

There is no information provided about how ground truth for a training set was established, as this document does not describe the development or validation of an algorithm or AI model.

Summary

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K033968 Page 1 of 1

510(k) PremarketNotification

Proprietary Name:	Hansson™ Pin System
Common Name:	Hip Fracture Fixation Device
Classification Name and Reference	Smooth or Threaded Metallic Bone Fixation Fastener21 CFR §888.3040
Regulatory Class:	Class II
Device Product Code:	87 HTY: Pin, Fixation, Smooth
For Information contact:	Vivian Kelly, Regulatory Affairs SpecialistHowmedica Ostconics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581Fax: (201) 831-6038
Date Summary Prepared:	12/18/03

510(k) Summary for the Hansson™ PinSystem Line Extension

Description:

Intended Use:

The Hansson" Pin System is intended for use in the temporary stabilization of various types of fractures of the proximal femur. The subject device is indicated for fixation of proximal fractures including but not limited to:

intracapsular fractures of the femoral neck such as transcervical and subcapital neck fractures, .
basal neck fractures, and .
slipped capital femoral epiphysis (SCFE) in pediatric patients. .

Substantial Equivalence:

The design and function of the Hansson" Pin are substantially equivalent to that of the predicate devices. Both the subject and predicate Hansson" Pin Systems offer pins in varying lengths while the ASNIS" II & III Cannulated Bone Screws are indicated for the fixation of Slipped Capital Femoral Epiphysis.

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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 stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is positioned above a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle, with the bird symbol placed in the center.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K033968

Trade/Device Name: Hansson" Pin System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HTY Dated: December 18, 2003 Received: December 22, 2003

Dear Ms. Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of 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 encrosals) to regary and the Medical Device Amendments, or to commerce pror to may 20, 1978, the encordance with the provisions of the Federal Food, Drug, de vices that have been rochasined in quire approval of a premarket approval application (PMA). and Cosmeter For (110) the envice, subject to the general controls provisions of the Act. The r ou may, dicierore, mance of the Act include requirements for annual registration, listing of general controls provision 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 n your de rice to such additional controls. Existing major regulations affecting your device can may be subject to bach address legulations, 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 r head be aar made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 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 Of It 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.

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Page 2 - Ms. Vivian Kelly

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) 594-4659. 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 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,

Mark N Mulkerson

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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510(k) Number (if known): K033968

Device Name: Hansson™ Pin System

Intended Use

Intracapsular fractures of the femoral neck such as Transcervical and Subcapital Neck . Fractures
Basal Neck Fractures .
Slipped Capital Femoral Epiphysis (in pediatric patients) .

Prescription Use.	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K033968

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.