The Union Surgical, LLC Threaded Fixation Pins are intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.

Device Description

The Union Surgical, LLC Taras Threaded Fixation Pins are threaded stainless steel Steinmann pins used for the repair of wrist fractures. The device incorporates a break-off shank. The device is optionally supplied with removal tools that permit pin extraction.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Taras Threaded Fixation Pin. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria and performance metrics typically seen in studies for novel, higher-risk devices or AI-powered diagnostics.

Therefore, the information requested in your prompt related to acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details is not present in the provided document.

Here’s a breakdown based on the available information:

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

Acceptance Criteria: Not explicitly stated as performance metrics with thresholds. The acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to a predicate device. This is achieved through:
- Comparison of technological characteristics.
- Comparison of mechanical performance.
- Compliance with recognized standards.

Reported Device Performance:

Aspect	Reported Performance/Basis of Equivalence
Technological Characteristics	Found to be substantially equivalent to the Zimmer Threaded Steinmann Pin through a 12-point comparison of features.
Mechanical Performance	Found to be substantially equivalent to the Zimmer Threaded Steinmann Pin through a 3-parameter comparison.
Standards Compliance	Complies with: - ASTM F366 - 82 (Reapproved 2000), Standard Specification for Fixation Pins and Wires - ASTM F138 - 97, Standard Specification for Wrought 18 Chromium-14Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) - ASTM F899 - 95, Standard Specification for Stainless Steel Billet, Bar and Wire for Surgical
Material Safety	Implantable and tissue contact materials have a "long history of safe usage in medical devices."

2. Sample sized used for the test set and the data provenance

This information is not provided. The submission relies on technological and mechanical comparisons, and compliance with standards, rather than clinical test sets with data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The concept of "ground truth" established by experts for a test set is not applicable to this type of marketing submission.

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

This information is not provided. Not applicable to this type of submission.

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

No MRMC study was done. This device is a physical fixation pin, not an AI diagnostic tool.

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

No standalone algorithm performance study was done. This device is a physical fixation pin, not an algorithm.

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

The concept of "ground truth" from these categories is not applicable to this submission. The "truth" for this submission is whether the device is "substantially equivalent" to a predicate device based on its design, materials, and mechanical properties, and whether it complies with relevant engineering standards.

8. The sample size for the training set

This information is not provided. A "training set" is not relevant for this type of medical device submission.

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

This information is not provided. Not relevant for this type of medical device submission.

In summary: The provided document is a 510(k) submission primarily demonstrating "substantial equivalence" of a physical medical device (Taras Threaded Fixation Pin) to a legally marketed predicate device (Zimmer Threaded Steinmann Pin). The evaluation relies on comparisons of technological characteristics, mechanical performance, and adherence to established engineering standards, rather than clinical studies with test sets, expert consensus, or performance metrics typical of diagnostic or AI-powered devices.

Summary

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OCT 2 2 2003

32532
Page 1 of 2

Summary of Safety and Effectiveness for the Taras Threaded Fixation Pin

submitted by Union Surgical, LLC 834 Chestnut Street Philadelphia, PA 19107 Phone: (215)-521-3009

Contact Person:	Al Weisenborn
Device Trade Name:	Taras Threaded Fixation Pin
Common Name:	Threaded Pin
Classification Name:	Smooth or threaded metallic bone fixation fastener per 21 CFR§ 888.3040

Identification of a Legally Marketed Predicate Device

The Union Surgical, LLC Taras Threaded Fixation Pin is substantially equivalent to Threaded Steinmann Pin that is legally marketed and distributed by Zimmer.

Device Description

Intended Use

The Union Surgical, LLC Threaded Fixation Pins are intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.

Summary of Technological Characteristics

An 12-point comparison of technological characteristics of the Union Surgical, LLC Taras Threaded Fixation Pin and the Zimmer Threaded Steinmann Pin was performed. The devices were found to be substantially equivalent.

Summary of Performance Data

The Union Surgical, LLC Taras Threaded Fixation Pins comply with the following standards, practices, and guidances:

ASTM F366 82 (Reapproved 2000), Standard Specification for Fixation . Pins and Wires

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ASTM F138 97, Standard Specification for Wrought 18 Chromium-14 . Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
. ASTM F899 - 95, Standard Specification for Stainless Steel Billet, Bar and Wire for Surgical

The Union Surgical, LLC Taras Threaded Fixation Pin is substantially equivalent to Threaded Steinmann Pin that is legally marketed and distributed by Zimmer. This has been demonstrated through a 12-point technological comparison of features and a 3parameter comparison of mechanical performance.

The Implantable and tissue contact materials used to fabricate the Taras Threaded Fixation Pin and Instruments have a long history of safe usage in medical devices. Since the Union Surgical, LLC Taras Threaded Fixation Pins meet the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as, or better than, the predicate device. The Taras Threaded Fixation Pin will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 2003

Mr. Al Weisenborn Union Surgical, LLC 834 Chestnut Street, Suite G114 Philadelphia, PA 19107

Re: K032532

Trade/Device Name: Taras Threaded Fixation Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: July 29, 2003 Received: August 18, 2003

Dear Mr. Weisenborn:

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 contrôls 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 vour 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 forth in the quality systems (OS) 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 - Mr. Al Weisenborn

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,

Sincerely, yours,

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

Page 1 of 1

KO3255 510(k) Number (if known):

Device Name: Taras Threaded Fixation Pin

Indications for Use:

The Union Surgical, LLC Threaded Fixation Pins are intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.

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, Re storative
	and Neurological Devices
Prescription Use	X
(Per 21 CFR 801.109)
	OR
	Over-The-Counter Use
510(k) Number	K032532

(Optional Format 1-2-96)

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.