ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM

• K Number: K141571
• Device Name: ORTHOFIX ANKLE HINDFOOT NAILING SYSTEM
• Manufacturer: ORTHOFIX SRL
• Date Cleared: 2014-11-12 ( 153 days)
• Product Code: HSB
• Regulation Number: 888.3020
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K091976
• Predicate For: N/A

Intended Use

The Orthofix Ankle Hindfoot Nailing System is intended to facilitate tibiotalocalcaneal arthrodesis (fusion). Specific indications include:

1. Avascular necrosis of the talus
2. Failed total ankle arthroplasty
3. Trauma (malunited tibial pilon fracture)
4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
5. Revision ankle arthrodesis
6. Neuroarthropathy
7. Rheumatoid arthritis
8. Osteoarthritis
9. Pseudoarthrosis
10. Post-traumatic arthrosis
11. Previously infected arthrosis
12. Charcot foot
13. Severe endstage degenerative arthritis
14. Severe defects after tumor resection
15. Pantalar arthrodesis

Device Description

The Orthofix Ankle Hindfoot Nailing System comprises a variety of implantable intramedullary nails with respective locking end caps and locking screws manufactured from titanium alloy (Ti6Al4V) which are intended to facilitate tibiotalocalcaneal arthrodesis (fusion). The system also includes instrumentation required for implantation and explantation of the implants.

AI/ML Overview

Here's an analysis of the provided text regarding the Orthofix Ankle Hindfoot Nailing System, focusing on the acceptance criteria and the study that proves the device meets them:

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

Acceptance Criteria (from predicate device/standard)	Reported Device Performance (Orthofix Ankle Hindfoot Nailing System)
Mechanical properties consistent with ASTM F1264-03 for intramedullary fixation devices	Meets ASTM F1264-03 for Static Four-Point Bend, Static Torsion, and Bending Fatigue testing.
Substantial equivalence to predicate device (Biomet Phoenix Ankle Arthrodesis Nail System – K091976) in terms of general design dimensions, intended use, materials, and performance characteristics.	The study concluded that the Orthofix Ankle Hindfoot Nailing System is substantially equivalent to the predicate device based on similarities in design, materials, intended use, indications for use, and the results of mechanical testing.

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

The document describes non-clinical mechanical testing of the device components. It does not refer to a "test set" in the context of patient data. Therefore, questions about patient sample size and data provenance (country, retrospective/prospective) are not applicable to the type of study conducted here.

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)

This question is not applicable. The ground truth for mechanical testing is established by engineering standards (ASTM F1264-03) and the physical properties of the materials and device. Expert consensus related to clinical interpretation or diagnosis is not relevant for this type of submission.

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

This question is not applicable, as the study involves mechanical testing against a standard, not the interpretation of clinical data by multiple experts.

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 question is not applicable. The device is a physical intramedullary nailing system, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.

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

This question is not applicable as the device is a physical medical implant, not an algorithm.

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

The ground truth used for this submission is based on:

• Engineering standards: Specifically, ASTM F1264-03 "Standard Specification and Test Methods for Intramedullary Fixation Devices."
• Performance of a legally marketed predicate device: The Biomet Phoenix Ankle Arthrodesis Nail System (K091976) serves as the benchmark for substantial equivalence.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of mechanical testing of a physical device. Design and manufacturing processes are iterative but do not involve "training data" in the AI sense.

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

This question is not applicable for the reasons stated above (no training set).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

November 12, 2014

Orthofix Srl % Mr. Troy Brooks Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056

Re: K141571

Trade/Device Name: Orthofix Ankle Hindfoot Nailing System 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 Mr. Brooks,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address

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

Sincerely yours, 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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Indications for Use

510(k) Number (if known)

K141571

Device Name Orthofix Ankle Hindfoot Nailing System

Indications for Use (Describe)

The Orthofix Ankle Hindfoot Nailing System is intended to facilitate tibiotalocalcaneal arthrodesis (fusion). Specific indications include:

• 1. Avascular necrosis of the talus
• 2. Failed total ankle arthroplasty
• 3. Trauma (malunited tibial pilon fracture)
• 4. Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis
• or other neuromuscular disease
• 5. Revision ankle arthrodesis
• 6. Neuroarthropathy
• 7. Rheumatoid arthritis
• 8. Osteoarthritis
• 9. Pseudoarthrosis
• 10. Post-traumatic arthrosis
• 11. Previously infected arthrosis
• 12. Charcot foot
• 13. Severe endstage degenerative arthritis
• 14. Severe defects after tumor resection
• 15. Pantalar arthrodesis

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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5.0 510(k) Summary

Date Prepared:	October 10, 2014
Purpose for Submission:	New product offering
Sponsor:	Orthofix SrlVia delle Nazioni 937012 Bussolengo (VR)Italy
Contact:	OrthofixTroy Brooks, RACTel: 214-937-2047Fax: [phone]
Trade Name /Proprietary Name:	Orthofix Ankle Hindfoot Nailing System
Common Name:	Intramedullary Nail
Product Code:	HSB - Rod, Fixation, Intramedullary And Accessories
Classification:	Class II - 21 CFR § 888.3020 - Intramedullary Fixation Rod
Predicate Device:	Biomet Phoenix Ankle Arthrodesis Nail System – K091976
Device Description:	The Orthofix Ankle Hindfoot Nailing System comprises a variety ofimplantable intramedullary nails with respective locking end caps andlocking screws manufactured from titanium alloy (Ti6Al4V) which areintended to facilitate tibiotalocalcaneal arthrodesis (fusion). The systemalso includes instrumentation required for implantation and explantationof the implants.
Intended Use /Indications For Use:	The Orthofix Ankle Hindfoot Nailing System is intended to facilitatetibiotalocalcaneal arthrodesis (fusion). Specific indications include:1. Avascular necrosis of the talus2. Failed total ankle arthroplasty3. Trauma (malunited tibial pilon fracture)4. Severe deformity or instability as a result of talipes equinovarus,cerebral vascular accident, paralysis or other neuromuscular disease5. Revision ankle arthrodesis6. Neuroarthropathy7. Rheumatoid arthritis8. Osteoarthritis9. Pseudoarthrosis10. Post-traumatic arthrosis11. Previously infected arthrosis12. Charcot foot13. Severe endstage degenerative arthritis14. Severe defects after tumor resection15. Pantalar arthrodesis
TechnologicalCharacteristics	The technological characteristics of the Orthofix Ankle Hindfoot NailingSystem are similar to the predicate device in terms of general design

Summary:

dimensions, intended use, materials, and performance characteristics.

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Image /page/5/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue, abstract shape on the left, followed by the word "ORTHOFIX" in bold, black letters. A small registration mark is present to the right of the word "ORTHOFIX".

The following technological differences exist between the Orthofix Ankle Hindfoot Nailing System and the predicate device:

• The intramedullary nails have a distal flare
• The intramedullary nails have additional fixation points in some lengths
• The intramedullary nails have a smaller inner diameter

System is substantially equivalent to the predicate device.

• The locking screws are also offered in a threaded-head version
• The locking screws are also offered in lengths of 115mm and 120mm

Non-Clinical Testing:	Mechanical testing of the Orthofix Ankle Hindfoot Nailing Systemconsisting of Static Four-Point Bend testing, Static Torsion testing, andBending Fatigue testing was conducted in accordance with ASTM F1264-03 “Standard Specification and Test Methods for Intramedullary FixationDevices.” Test results demonstrate that the Orthofix Ankle HindfootNailing System is substantially equivalent to the predicate device.
Substantial:	Based upon similarities in design, materials, intended use, indications for
Equivalence:	use and the results of mechanical testing, the Orthofix Hindfoot Nailing

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.