FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Zimmer Natural Nail System Cephalomedullary Nails (ZNN™ CMN) are intramedullary nails intended for temporary internal fixation and stabilization of femoral fractures or osteotomies. Indications for the Zimmer Natural Nail System Cephalomedullary Nails (ZNN™ CMN) include:

· Compound and simple shaft fractures.
· Proximal, metaphyseal and distal shaft fractures.
· Segmental fractures.
· Comminuted fractures.
· Fractures involving osteopenic and osteoporotic bone.
· Pathological fractures.
· Fractures with bone loss
· Pseudoarthrosis, non-union, mal-union and delayed union.
· Periprosthetic fractures.
· Surgically created defects such as osteotomies.
· Intertrochanteric and subtrochanteric fractures.

The Affixus Natural Nail Humeral Nails are intramedullary nails intended for temporary internal fixation and stabilization of humeral fractures or osteotomies.

The Affixus Natural Nail Humeral Nail System is indicated for use in a variety of fractures, such as:
· Proximal fractures (proximal short and long nails only).
· Diaphyseal fractures (proximal long nails and antegrade/retrograde nails only).
· Open and closed fractures.
· Comminuted fractures.
· Nonunions and malunions.
Pathologic fractures.

Device Description

The Zimmer Natural Nail System Cephalomedullary Nails are intramedullary nails designed to restore the shape of preinjured bone and are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail. A set screw (with a polyethylene peg) allows guided rotational stability of the lag screw. Nails, nail caps and screws are made from Tivanium Ti-6Al-4V Alloy. Set screws are made from Tivanium Ti-6Al-4V Alloy and Polyethylene (PE). Selected components of the Zimmer Natural Nail System are color coded to aid in identifying which components should be used together. The package label for each of the nails indicates which screw sizes should be used with that nail. Each section contains the color name that matches the color/color name on the label of the appropriate screw size for that section. Refer to the color coding chart and/or surgical technique for more detailed instructions on the use of Zimmer Natural Nail System components.

The Affixus Natural Nail Humeral Nail System consists of temporary fixation intramedullary nails designed for fixation and stabilization of fractures or osteotomies of the humerus. The nails restore the shape of preinjured bone and they are available in a variety of lengths and diameters to meet assorted anatomical needs. Nail caps are available to protect the nail threads from tissue ingrowth and extend the nail length if necessary. Each of the intramedullary nails is secured by a series of screws that pass through holes in the nail.

The Ante/Retrograde Humerus Nails, Ante/Retrograde Humeral Nail Caps, Proximal Humerus Nail Caps, Washers, Cortical Bone Screws, and Blunt Tip Screws are made of Titanium alloy [Protasul®-64WF (Ti-6Al-4V) ISO 5832-3/ASTM F136] and Proximal Humerus Nails are made of Titanium alloy [Protasul-64WF (Ti-6AI-4V) ISO 5832-3/ASTM F136] and C.P Titanium [Protasul®-Ti ISO 5832-2/ASTM F67].

Package labels indicate the material of each component. Selected components of the Affixus Natural Nail Humeral Nail System instruments are color coded to aid in identifying which components should be used together. Refer to the surgical techniques for more detailed instructions on the use of Affixus Natural Nail Humeral Nail System components.

The purpose of this traditional bundled 510(k) is to update the Instructions for Use (IFU) and labels of the Zimmer® Natural Nail® System Cephalomedullary Nails and Affixus® Natural Nail® Humeral Nail System to include MR Conditional labeling. Additionally, to harmonize the content format of the IFU, some chapters of the IFUs are reorganized.

AI/ML Overview

This 510(k) summary does not contain information on acceptance criteria for a device, nor does it present a study to prove a device meets acceptance criteria related to clinical performance. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices, primarily due to updates in labeling for MR Conditional compatibility and harmonization of IFU format.

Here's a breakdown of the relevant information from the provided text:

No Clinical Acceptance Criteria or Performance Data: The document explicitly states under "Clinical Performance and Conclusions:" that "Clinical data and conclusions were not needed for this device." This indicates that the submission is not based on proving clinical effectiveness against specific acceptance criteria.
Focus on Substantial Equivalence: The primary purpose of this 510(k) is to update labeling (specifically for MR Conditional use) and re-organize the Instructions for Use (IFU) for existing devices. The submission asserts substantial equivalence to legally marketed predicate devices based on identical intended use, indications for use, device description, materials, design features, lengths and diameters, and sterilization methods.

Therefore, I cannot provide the requested table of acceptance criteria and reported device performance from this document because it is not a clinical performance study.

However, I can extract the information related to the non-clinical performance testing conducted to support the MR Conditional labeling:

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Acceptance Criteria Description (Based on ASTM Standard)	Reported Device Performance (Implied adherence to standard)
ASTM F2503-20 (Labeling)	Devices meet labeling requirements for MR Conditional.
ASTM F2119-07R13 (Artifact)	Devices demonstrate acceptable artifact levels in MRI.
ASTM F213-17 (Torque)	Devices exhibit acceptable torque behavior in MRI.
ASTM F2052-21 (Displacement Force)	Devices show acceptable displacement forces in MRI.
ASTM F2182-19E02 (RF-heating) Preliminary Phantom Eval.	Devices have acceptable RF-heating characteristics in MRI (preliminary phantom evaluation).

Sample size used for the test set and the data provenance: Not specified in the document. Testing would typically involve representative samples of the devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Non-clinical testing for MR compatibility is typically performed by engineers/technicians in a laboratory setting, following established ASTM protocols.
Adjudication method for the test set: Not applicable. Results are typically quantitative measurements compared against predefined limits within the ASTM standards.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is a non-clinical submission for MR compatibility labeling updates, not a clinical effectiveness study.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is not an AI/algorithm-based device.
The type of ground truth used: For the non-clinical MR compatibility testing, the "ground truth" is defined by the limits and methodologies specified in the referenced ASTM standards.
The sample size for the training set: Not applicable. This is not a machine learning or AI-based device.
How the ground truth for the training set was established: Not applicable.

Summary

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.