Ins Hilden Tibial Arzzt is intended to stabilize fractures of the tibial shaft; open and closed tibial shaft fractures; and tibial malunion and non-unions.

Device Description

The Ins Hilden Tibial Arzzt is a single use system that consist the following components:

The Tibial Nail: a solid nail, with four orifices, two for distal locking and two for the proximal . locking. One of the orifices on the proximal locking is for static locking and one for dynamic locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole.
Locking Screws with conical head and self-tapping on the head and blunt.
End caps.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Ins Hilden Tibial Arzzt", an intramedullary fixation rod. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, most of the requested information cannot be extracted directly from this document.

However, based on the standards and tests performed, we can infer the acceptance criteria for mechanical performance and the study that proves the device meets those criteria.

Inferred Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Inferred from Standards)	Reported Device Performance (Summary from Section 14)
Material Properties	Conformance to ISO 5832-03:1996 for Wrought titanium 6-aluminum 4-vanadium alloy	Device materials meet ISO 5832-03:1996 (Standard listed as met).
Mechanical Performance	Static Bending Strength: Equivalent to predicate device (Synthes UTN 8 mm)	Engineering analysis demonstrates Ins Hilden Tibial Arzzt 8mm Tibial Nail's static bending yield strength is substantially equivalent to Synthes UTN 8mm.
	Static Torsional Strength: Equivalent to predicate device (Synthes UTN 8 mm)	Engineering analysis demonstrates Ins Hilden Tibial Arzzt 8mm Tibial Nail's static torsional yield strength is substantially equivalent to Synthes UTN 8mm.
	Performance under Static Testing (ASTM F-1264)	Device met the requirements in Static Testing as per ASTM F-1264.
	Performance under Torsion Testing (ASTM F-1264)	Device met the requirements in Torsion Testing as per ASTM F-1264.
	Performance under Fatigue Testing (ASTM F-1264)	Device met the requirements in Fatigue Testing as per ASTM F-1264.
Permanent Marking	Conformance to ASTM F 983-86 (Reapproved 2009) for permanent marking of orthopedic implant components	Device met the requirements of ASTM F 983-86 (Standard listed as met).

Study Information (Based on the provided text):

Sample size used for the test set and the data provenance:
- The document describes mechanical testing and engineering analysis rather than a clinical human study. The sample size for the mechanical tests (e.g., number of nails tested) is not specified in the provided text.
- Data provenance: No information on country of origin. The data is from in vitro mechanical testing and engineering analysis as part of a regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a device clearance based on substantial equivalence through mechanical testing, not a clinical study requiring expert ground truth for interpretation of outcomes or diagnoses.
Adjudication method for the test set:
- Not applicable for mechanical testing. The assessment is against specified ASTM and ISO standards directly.
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. This is a 510(k) for an intramedullary fixation rod, not an AI/software device, and no MRMC study is described.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical performance, the "ground truth" is established by the engineering standards (ASTM F-1264, ISO 5832-03) and the mechanical properties of the predicate device. The device performance is compared directly against these established benchmarks.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical testing for a physical device.
How the ground truth for the training set was established:
- Not applicable. See #7.

Summary of Study that Proves Device Meets Acceptance Criteria:

The study described is a series of in vitro mechanical tests and an engineering analysis conducted to demonstrate that the Ins Hilden Tibial Arzzt is substantially equivalent to its predicate devices concerning mechanical performance and material properties.

Mechanical Testing: Performed according to ASTM F-1264 ("Standard Guide for Mechanical Performance Considerations for Intramedullary Fixation Devices"), including:
- Static Testing
- Torsion Testing
- Fatigue Testing
  The device met the requirements in these categories.
Engineering Analysis: A comparative analysis was performed to compare the static bending and static torsional yield strengths of the Ins Hilden Tibial Arzzt 8 mm Tibial Nail to the Synthes UTN 8 mm (predicate device). This analysis proved the device to be as strong as the predicate device.
Material Conformance: The device components conform to ISO 5832-03:1996 for wrought titanium 6-aluminum 4-vanadium alloy.
Marking Conformance: The device marking conforms to ASTM F 983-86 (Reapproved 2009).

This approach, leveraging established industry standards and direct comparison to a legally marketed predicate device, is typical for demonstrating substantial equivalence in 510(k) submissions for similar medical devices.

Summary

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Image /page/0/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter, with "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" clearly visible. At the center of the seal is a stylized emblem consisting of three overlapping profiles, which are meant to represent the health and well-being of individuals and communities.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 6, 2014

Trumed Group, LLC % Ms. Rhonda Alexander Senior Regulatory Specialist Registrar Corporation 144 Research Drive Hampton, Virginia 23669

Re: K133166

Trade/Device Name: Ins Hilden Tibial Arzzt Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 10, 2014 Received: October 14, 2014

Dear Ms. Alexander:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Rhonda Alexander

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133166

Device Name

Ins Hilden Tibial Arzzt

Indications for Use (Describe)

Ins Hilden Tibial Arzzt is intended to stabilize fractures of the tibial shaft; open and closed tibial shaft fractures; and tibial malunion and non-unions.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

	FOR FDA USE ONLY
	Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (1/14)	Page 1 of 1
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Premarket Notification 510(k) Summary

1.	Submitter's Name:	Trumed Group LLC
2.	Contact Person:	Jorge Trujillo Zavala600 Kenrick C-32Houston, Texas 77060281 847 4098 (phone)
3.	Date Prepared:	August 13, 2013
4.	Device Name:	Ins Hilden Tibial Arzzt
5.	Common Name:	Intramedullary Nail and Locking Screws
6.	Classification Name:	Intramedullary Fixation Rod
7.	Product Code:	HSB
8.	Device Classification:	Class 2
9.	Regulation Number:	21 CFR 888.3020
10.	Predicate Devices:	Synthes (USA)Universal Tibial Nail and Unreamed TibialNailK914453Synthes (USA)Ti-6al-7nb UrtnK932330

11. Device Description:

The Ins Hilden Tibial Arzzt is a single use system that consist the following components:

The Tibial Nail: a solid nail, with four orifices, two for distal locking and two for the proximal . locking. One of the orifices on the proximal locking is for static locking and one for dynamic locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole.

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Image /page/4/Picture/0 description: The image shows the logo for ARZZT. The logo features the letters "ARZZT" in a dark gray, sans-serif font. Above the letters, there is a stylized graphic of a person with their arms raised, also in dark gray. A blue swoosh arcs over the person and the letters, adding a dynamic element to the design.

Locking Screws with conical head and self-tapping on the head and blunt. ●
End caps.
1. Intended Use: Ins Hilden Tibial Arzzt is intended to stabilize fractures of the tibial shaft; open and closed tibial shaft fractures; and tibial malunion and non-unions.
1. Standards

ASTM F 983-86 (Reapproved 2009). Standard Practice for Permanent Marking of Orthopedic Implant Components

ASTM F1264-03 (Reapproved 2007). Standard Specification and Test Methods for Intramedullary Fixation Devices

ISO 5832-03:1996. Implants for surgery - Metallic materials - Part 3: Wrought titanium 6aluminum 4-vanadium allov

The Ins Hilden Tibial Arzzt has met the requirements of the above standards.

1. Comparison of Technological Characteristics and Substantial Equivalence The Ins Hilden Tibial Arzzt has similar intended use, target population, anatomical sites, materials, biocompatibility as the Ti-6al-7nb Urtn and the UTN.
  The engineering analysis comparing the static bending and static torsional yield strengths of the Ins Hilden Tibial Arzzt 8 mm Tibial Nail to the Synthes UTN 8 mm demonstrates that the performance and properties of Ins Hilden Tibial Arzzt are substantially equivalent to the predicate device.

Test Performed

According the ASTM F-1264: Standard Guide for Mechanical Performance Considerations for Intramedullary Fixation Devices, our system was tested and met the requirements in the following categories:

Static Testing
Torsion Testing
Fatigue Testing ●

Also, we performed an engineering analysis comparing the static bending and static torsional yield strengths of the Ins Hilden Tibial 8 mm Tibial Nail to the Synthes UTN 8 mm proving to be as strong as the predicate device.

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.