Intramedullary Nail and Screws for Tibia - NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions or nonunions of the tibia. Intramedullary Nail and Screws for Tibia - NEONAIL is indicated for tibial fracture fixation, which may include:

· Open and closed tibial fractures;
· Pseudoarthodlosis and correction osteotomy;
· Pathologic fractures, impending pathologic fractures and tumor resections; and
· Nonunions and malunions.

The Intramedullary Nail and Screws for Humerus – NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.

Device Description

An intramedullary nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. Intramedullary Nail and Screws – NEONAIL consists of metal rods, bone screws, and end caps. All components are made from Ti-6AI-4V alloy. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations.

AI/ML Overview

The document describes the device Intramedullary Nail and Screws - NEONAIL, which is an orthopedic implant for fracture fixation.

Here's an analysis of 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 Category	Specific Test/Performance Metric	Acceptance Criteria (from document)	Reported Device Performance
Mechanical Performance	Static Four-Point Bending	Not explicitly stated (comparison to predicates)	"worst case nail... subjected to mechanical performance testing according to ASTM F1264"
	Static Torsion	Not explicitly stated (comparison to predicates)	"worst case nail... subjected to mechanical performance testing according to ASTM F1264"
	Bending Fatigue	Not explicitly stated (comparison to predicates)	"worst case nail... subjected to mechanical performance testing according to ASTM F1264"
	Torsional Properties (Screws)	Not explicitly stated (comparison to predicates)	"worst case screws... subjected to mechanical performance testing according to ASTM F543"
	Driving Torque (Screws)	Not explicitly stated (comparison to predicates)	"worst case screws... subjected to mechanical performance testing according to ASTM F543"
	Axial Pullout Strength (Screws)	Not explicitly stated (comparison to predicates)	"worst case screws... subjected to mechanical performance testing according to ASTM F543"
	Self-Tapping Performance (Screws)	Not explicitly stated (comparison to predicates)	"worst case screws... subjected to mechanical performance testing according to ASTM F543"
Material Equivalence	Material Composition	Identical to predicate devices	"All components are made from Ti-6AI-4V alloy," which is stated to be identical to materials in cleared predicate devices.
Design Equivalence	Design Principles / Dimensions	Similar to predicate devices	"similar in indications, design, and dimensions" to predicate devices.
Intended Use	Match predicate devices	Same intended use as predicate devices	"has the same intended use" as predicate devices.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical study focusing on engineering analysis, dimensional analysis, and mechanical testing. The core strategy is demonstrating substantial equivalence to legally marketed predicate devices.

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

Sample Size: The document does not specify a numerical sample size for the mechanical testing of each individual nail or screw type. It refers to testing the "worst case nail for each indication" and "worst case screws available." This implies a selection of representatives rather than a broad statistical sample of every product variant.
Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given it's a non-clinical engineering and mechanical testing study, "retrospective" or "prospective" as typically applied to patient data is not directly applicable. The data would have been generated in a controlled laboratory setting.

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

This section is not applicable. The study is a non-clinical, engineering-focused evaluation. "Ground truth" in the context of expert consensus, pathology, or outcomes data is relevant for clinical or diagnostic device studies, not for the mechanical performance testing of an orthopedic implant. The "truth" here is determined by adherence to engineering standards (ASTM F1264, ASTM F543) and equivalence to predicate devices, which is evaluated by regulatory bodies based on submitted technical data.

4. Adjudication method for the test set

This section is not applicable. Adjudication typically refers to the process of resolving discrepancies among experts in clinical data review. For mechanical testing, the results are typically quantitative and objective measurements against defined standards, not subjective interpretations requiring adjudication.

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 section is not applicable. The device is an orthopedic implant (intramedullary nail and screws) used for fracture fixation, not a diagnostic or AI-driven imaging device. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this device.

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

This section is not applicable. The device is a physical medical implant, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

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

The "ground truth" for this non-clinical study is defined by:

Established engineering standards: Specifically ASTM F1264 (for intramedullary fixation devices) and ASTM F543 (for metallic bone screws). The device's performance is compared against the performance of predicate devices which are presumed to meet these standards.
Predicate device characteristics: The critical "truth" is that the Intramedullary Nail and Screws - NEONAIL performs sufficiently similarly to and is materially and structurally equivalent to the identified predicate devices (Howmedica Osteonics Corp. T2 Femoral Nail, Stryker T2 Femoral Nail, Stryker Trauma AG T2 Tibial Nailing System, Howmedica Osteonics Corp. T2 Proximal Humeral Nail, Howmedica Osteonics Corp. T2 Nailing System) to be considered substantially equivalent by the FDA.

8. The sample size for the training set

This section is not applicable. Since this involves mechanical testing and not machine learning or AI, there is no "training set."

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

This section is not applicable as there is no "training set."

Summary

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

September 23, 2014

NEOORTHO Produtos Ortopédicos S/A % Mr. Kevin A. Thomas, PhD PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130

Re: K141103

Trade/Device Name: Intramedullary Nail and Screws - NEONAIL Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: August 28, 2014 Received: August 28, 2014

Dear Dr. Thomas:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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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Indications for Use

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

Page

510(k) Number (if known) K141103

Device Name

Intramedullary Nail and Screws - NEONAIL

Indications for Use (Describe)

Intramedullary Nail and Screws for Femur - NEONAIL is indicated for femoral fracture fixation including:

· Open and closed femoral fractures;
· Pseudoarthrosis and correction osteotomy;
· Pathologic fractures, impending pathologic fractures, and tumor resections;
· Ipsilateral femur fractures;
· Fractures distal to the hip joint; and
Nonunions and malunions.

· Open and closed tibial fractures;
· Pseudoarthodlosis and correction osteotomy;
· Pathologic fractures, impending pathologic fractures and tumor resections; and
· Nonunions and malunions.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary NEOORTHO Produtos Ortopédicos S/A Intramedullary Nail and Screws – NEONAIL K141103

September 18, 2014

ADMINISTRATIVE INFORMATION

Manufacturer Name	NEOORTHO Produtos Ortopédicos S/ARua Ângelo Domingos Durigan, 607, CascatinhaCuritiba, Paraná 82025-100, Brazil
	Telephone:	+55 41 3535-1000
	Fax:	+55 41 3535-1018
Official Contact	Mariana de Oliveira Quinzani
	Regulatory Affairs
Representative/Consultant	Kevin A. Thomas, PhD
	Floyd G. Larson
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
	Telephone:	+1 (858) 792-1235
	Fax:	+1 (858) 792-1236
	Email:	kthomas@paxmed.com
		flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Intramedullary Nail and Screws - NEONAIL
Common Name	Rod, fixation, intramedullary and accessories
Classification Name	Intramedullary fixation rod
Classification Regulations	21 CFR 888.3020, Class II
Product Code	HSB
Classification Panel	Orthopedic Products Panel
Reviewing Branch	Joint Fixation Branch One

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INTENDED USE

Device Name: Intramedullary Nail and Screws - NEONAIL Femur

Intramedullary Nail and Screws for Femur – NEONAIL is indicated for femoral fracture fixation including:

Open and closed femoral fractures;
Pseudoarthrosis and correction osteotomy;
Pathologic fractures, impending pathologic fractures, and tumor resections;
Ipsilateral femur fractures;
Fractures distal to the hip joint; and ●
Nonunions and malunions. ●

Device Name: Intramedullary Nail and Screws - NEONAIL Tibia

Intramedullary Nail and Screws for Tibia – NEONAIL is intended to provide temporary stabilization of various types of fractures, malunions of the tibia. Intramedullary Nail and Screws for Tibia – NEONAIL is indicated for tibial fracture fixation, which may include:

. Open and closed tibial fractures:
. Pseudoarthodlosis and correction osteotomy;
Pathologic fractures, impending pathologic fractures and tumor resections; and ●
Nonunions and malunions. ●

Intramedullary Nail and Screws - NEONAIL Device Name: Humerus

The Intramedullary Nail and Screws for Humerus – NEONAIL is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include nonunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications include: AO classification Type A fractures, dislocated; AO classification Type B fractures, dislocated; AO classification Type C fractures with intact calotte; and humeral fractures according to the Neer Classification.

DEVICE DESCRIPTION

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EQUIVALENCE TO MARKETED DEVICE

Intramedullary Nail and Screws - NEONAIL is substantially equivalent in indications and design principles to the following predicate devices:

Howmedica Osteonics Corp., T2 Femoral Nail, K010801
Stryker, T2 Femoral Nail Model 1825-XXXXCP, 1828-XXXXCP, K112059 ●
Stryker Trauma AG, T2 Tibial Nailing System, K131365 ●
Howmedica Osteonics Corp., T2 Proximal Humeral Nail, K042396 ●
Howmedica Osteonics Corp., T2 Nailing System, K032523 ●

Intramedullary Nail and Screws – NEONAIL components have similar designs and identical materials as those cleared under K010801, K112059, K131365, K042396, and K032523. Intramedullary Nail and Screws for Femur – NEONAIL is similar in indications, design, and dimensions to those cleared in K010801 and K112059. Intramedullary Nail and Screws for Tibia - NEONAIL is similar in indications, design, and dimensions to those cleared in K131365. Intramedullary Nail and Screws for Humerus – NEONAIL is similar in indications, design, and dimensions to those cleared in K042396 and K032523.

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: engineering analysis, dimensional analysis and mechanical testing. The worst case nail for each indication in the Intramedullary Nail and Screws - NEONAIL product list was subjected to mechanical performance testing according to ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices (static four-point bending, static torsion, and bending fatigue).

The worst case screws available in the Intramedullary Nail and Screws – NEONAIL product list were subjected to mechanical performance testing according to ASTM F1264 Standard Specification and Test Methods for Intramedullary Fixation Devices (static four-point bending and bending fatigue) and ASTM F543 Standard Specification and Test Method for Metallic Bone Screws (torsional properties, driving torque, axial pullout strength, and self-tapping performance).

Clinical data were not submitted in this premarket notification.

Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

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510(k) Summary K141103

Overall, Intramedullary Nail and Screws – NEONAIL has the following similarities to the predicate devices:

has the same intended use, ●
uses the same operating principle,
incorporates the same basic design,
incorporates the same materials, and .
has similar packaging. ●

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.