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The BioDynamik XT3 System is indicated for fracture fixation and bone transport of the tibia in adults.

The XT3 System is composed of the XT3 fixator, Half Pins, and instrumentation, which includes a Spacer, a Drill and Cut Guide, and drivers. The XT3 Fixator and instruments are single-use devices and are supplied non-sterile intended to be steam sterilized prior to use. The Half Pins are provided sterile by gamma irradiation and are for single use only. The XT3 fixator can be adjusted via an incorporated lifting plate to provide fracture fixation or bone transport.

1. Table of Acceptance Criteria and Reported Device Performance

   The provided text does not contain a specific table detailing acceptance criteria for a quantitative performance metric and the XT3 System's corresponding performance. Instead, it describes general compliance with standards and successful completion of tests.

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

   • Test set sample size: While "All XT3 samples" are mentioned as passing their respective acceptance criteria for static loads, a specific numerical sample size for independent test sets for each test (axial, four-point bend, torsion, cadaver) is not provided in the document.
   • Data provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.

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

   • The document does not mention the use of experts to establish ground truth for the test set. The tests described are mechanical performance tests (compliance with ASTM standards, cadaver testing for successful use), which typically rely on objective measurements rather than expert interpretations or ground truth.

4. Adjudication method for the test set:

   • Not applicable. The described tests are primarily mechanical and cadaveric performance tests, not studies requiring adjudication of output from multiple readers or algorithms.

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:

   • Not applicable. The provided text describes a medical device (XT3 System - an external fixation device), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

   • Not applicable. The XT3 System is a physical medical device for fracture fixation and bone transport, not an algorithm.

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

   • For the mechanical tests (axial load, four-point bend, torsion), the "ground truth" or reference for performance is established by the acceptance criteria defined within ASTM F1541-17 Annex 7 and the device's own design inputs.
   • For cadaver testing, the "ground truth" is the successful demonstration that the XT3 System could be used in accordance with its intended use in a simulated anatomical environment.
   • No expert consensus, pathology, or outcomes data are mentioned as ground truth in the context of the described performance studies.

8. The sample size for the training set:

   • Not applicable. The XT3 System is a physical medical device, not a machine learning model that requires a training set.

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

   • Not applicable, as there is no training set for this device.

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Smith & Nephew's MAVERICK and MAVERICK Mini External Fixation System is intended to be used for temporary stabilization of the long bones, feet, pelvis, and wrist.

The indications for the Smith & Nephew MAVERICK Mini External Fixation System are the following:

• Open and closed fracture fixation
• Bony or soft tissue deformities

The subject of this premarket notification is the MAVERICK Mini External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet, wrist, and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite and titanium bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.

This is a medical device submission, specifically a Pre-Market Notification (510(k)) for the MAVERICK Mini External Fixation System. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to previously cleared predicate devices.

However, this document does not contain information regarding acceptance criteria and a study proving a device meets those criteria in the context of AI/ML or diagnostic performance. The "performance testing" section refers to bench testing for mechanical properties (e.g., torsional grip strength, axial grip strength, rigidity testing) typical for orthopedic fixation devices, not a study evaluating diagnostic accuracy, sensitivity, specificity, or human-in-the-loop performance which would require the acceptance criteria and study details you've outlined.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets those criteria based on the provided text, as this document focuses on mechanical substantial equivalence for an external fixation system.

The questions you've asked are typically relevant for submissions of AI/ML-driven diagnostic devices or imaging analysis software, which require clinical performance studies with specific statistical endpoints and ground truth establishment. This document is for a traditional medical device (an external fixation system).

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The MAVERICK External Fixation System is intended to be used for temporary stabilization of the long bones, feet, and pelvis.
The indications for the Smith & Nephew MAVERICK External Fixation System are the following:

• Open and closed fracture fixation
• Bony or soft tissue deformities

The subject of this premarket notification is the MAVERICK External Fixation System. The system is an external fixation system that consists of various components used in the management of pelvic, feet and long bone fractures and reconstructive and corrective orthopedic surgery. The system consists of stainless steel bone pins, composite bars, and titanium clamps. These components can be combined to build a frame which is appropriate for each specific application.

The provided text is a 510(k) Premarket Notification from the U.S. FDA for the MAVERICK External Fixation System. It details the device's intended use, regulatory classification, and comparisons to predicate devices. However, the document does not contain information about a study proving the device meets acceptance criteria related to AI/Machine Learning performance, diagnostic accuracy, or human reader improvement with AI assistance.

The performance testing section (on page 4) exclusively describes mechanical bench testing of the device's components and full constructs, such as grip strength, resistance to slip, and cyclic testing of frames. This type of testing is standard for orthopedic devices to demonstrate structural integrity and durability, not diagnostic accuracy or AI performance.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information regarding:

1. A table of acceptance criteria and the reported device performance for an AI/diagnostic device. The provided "Device Testing" table lists mechanical tests, not diagnostic performance metrics.
2. Sample size used for the test set and data provenance: No such data is mentioned.
3. Number of experts used to establish ground truth and their qualifications: Not applicable to mechanical testing.
4. Adjudication method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The document is about a Class II medical device for temporary stabilization of bones, and the "study" described is entirely focused on mechanical performance and biocompatibility, not on diagnostic accuracy or AI-powered assistance.

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The Steinmann Pins are intended to be used in conjunction with a compatible Stryker external supporting frame for stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

The Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning, and as fracture fixation devices in certain other small bone fractures.
• For use as guide wires in hip pinning procedures,
• For use in aligning and reducing long bone fractures,
• For use in securing temporary stabilization of bone fractures such as olecranon fractures; patella fractures; tibia plateau fractures; small hand and foot bone fractures; humeral, radial and ulnar fractures.
• For use with cerclage wire/cable in treating greater trochanter fractures.

The Steinmann Pins and Kirschner Wires are designed for multiple purposes which allow the use in skeletal traction for alignment and reduction of bone fractures, function as fracture fixation devices in certain fractures, preliminary fixation for implants (for example plates) and for evaluation of screw trajectories or guidance for cannulated instruments.

The Steinmann Pins and Kirschner Wires are available in different dimensions and provide several design features. The dimensions vary in diameter and length. The design features are the tip geometry which can be a three-sided trocar tip or a two-sided diamond tip on either one end or both ends of the pin. Additionally, some pins are threaded.

The pins and wires are made from stainless steel (1.4441).

The provided document is a 510(k) Summary for Steinmann Pins and Kirschner Wires. It states that clinical data and conclusions were not needed to demonstrate substantial equivalence to the predicate devices. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for a clinical study is not available in this document.

The document primarily focuses on non-clinical performance data and relies on equivalence to predicate devices and adherence to international standards.

Here's a breakdown of the available information relevant to performance:

1. Table of Acceptance Criteria and Reported Device Performance:

Since clinical data was not required, there isn't a table of specific clinical acceptance criteria vs. device performance. Instead, the "Performance Data (Nonclinical)" section details how substantial equivalence was demonstrated.

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

• Not applicable (N/A): No clinical test set or data provenance is mentioned as clinical data was not needed. The assessment was based on non-clinical performance and equivalence to predicate devices.

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

• N/A: No clinical test set or ground truth established by experts is mentioned.

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

• N/A: No clinical test set or adjudication method is mentioned.

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:

• N/A: The device is a physical medical device (pins and wires), not an AI diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

• N/A: The device is a physical medical device, not an algorithm.

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

• N/A: For the substantial equivalence determination, the "ground truth" was established through comparison to legally marketed predicate devices and adherence to relevant non-clinical performance standards.

8. The sample size for the training set:

• N/A: No training set is mentioned as this is not an AI/machine learning device.

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

• N/A: No training set is mentioned.

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The Extended HA Half Pins are intended to be used with an external fixation system for fixation of fractures of long bones, joint fusions, and limb lengthening or deformity corrections that involve cutting of the bone and temporary stabilization for the indications listed below.

1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
2. Open and closed fracture fixation
3. Pseudarthrosis of long bones
4. Limb lengthening by distraction
5. Correction of bony or soft tissue deformities
6. Joint arthrodesis
7. Infected fractures
8. Nonunions

Subject of this premarket notification is the Extended HA Half Pins. The proposed devices are design modifications of the Jet-X HA Coated Half Pins to extend the HA coating to the shank of the Half Pins.

I am sorry, but the provided text describes the regulatory clearance of a medical device, specifically Extended HA Half Pins from Smith & Nephew, Inc., and does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria related to AI or image analysis.

The document is a 510(k) premarket notification clearance letter from the FDA, along with the Indications for Use and a summary of the device. It focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (bone fixation pins), not a software or AI-powered diagnostic tool.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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The Steinmann pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.

The Syntec Non-Sterile Steinmann Pins System is modify from our own device from K983121-Non-Sterile Kirschner Wires and Steinmann Pins product systm. The modify Pins are fabricated from stainless steel (SUS316L) per ASTM F138-13.The design feature for the Non-Sterile Steinmann Pins System is similar to the predicate devices including dimensions, shape, style and sizes.

This document is a 510(k) premarket notification for the Syntec Non-Sterile Steinmann Pins System. It explicitly states that clinical data and conclusions were not needed for these devices and performance tests are not required to support substantial equivalence in special 510k.

Therefore, the provided text does not contain any information about:

• Acceptance criteria related to device performance in a clinical or non-clinical study.
• Reported device performance from such a study.
• Sample sizes used for test or training sets.
• Data provenance.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth.
• MRMC studies, effect sizes, or standalone algorithm performance.
• Type of ground truth used.
• How ground truth for a training set was established.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K983121 - Non-Sterile Kirschner Wires and Steinmann Pins product system) based on:

1. Identical Intended Use and Indications for Use: The Steinmann pins are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, and as guide pins for insertion of other implants.
2. Technological Characteristics: The modified pins are fabricated from stainless steel (SUS316L) per ASTM F138-13, and their design features (dimensions, shape, style, and sizes) are similar to the predicate devices.
3. Conformance to Standards: The device was considered in conformance with dimensional and material mechanical property standards ASTM F138-13, ASTM F366-10, and ISO 5838-1.

In summary, the provided text does not describe a study involving performance testing against acceptance criteria. It's a regulatory submission demonstrating equivalence for a medical device that, due to its nature as a "Special 510(k)," did not require extensive clinical or non-clinical performance data for clearance.

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Orthopedic Fixation Pin is indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants.

The Orthopedic Fixation Pin is straight, partially threaded; and has trocar point on one end. The device is available in various diameters and lengths to accommodate the specific indication. The pins are made from stainless steel in accordance with ASTM F138-13.

The provided text is a 510(k) premarket notification for an Orthopedic Fixation Pin. It focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, primarily through non-clinical performance data (bench testing and biocompatibility).

Crucially, this document does not describe a study that uses an AI/ML device, nor does it contain acceptance criteria or performance data for such a device. The "Orthopedic Fixation Pin" is a physical medical device, not a software or AI-driven diagnostic or assistive tool.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided input does not pertain to an AI/ML device.

Here's why the information you're asking for is absent in the document:

• Device Type: The "Orthopedic Fixation Pin" is a physical implant used for bone fixation. It is not an AI/ML algorithm or system.
• Performance Data: The performance data presented (static pullout, static torsion, tensile testing, biocompatibility) are standard engineering and materials tests for physical medical implants, not metrics like sensitivity, specificity, AUC, or reader performance improvement typically used for AI/ML devices.
• Clinical Studies: The document explicitly states, "No data from human clinical studies have been included to support the substantial equivalence of the proposed device, Orthopedic Fixation Pin, as clinical studies are not required for this medical device." This confirms that no clinical performance data, let alone data relevant to AI/ML device evaluation (like MRMC studies or human-in-the-loop performance), was generated or submitted.
• Ground Truth: The concept of "ground truth" as it applies to AI/ML (e.g., expert consensus on image interpretation, pathology reports) is not relevant to a physical pin. The "ground truth" for the pin is its adherence to material specifications and mechanical properties.

If you have a document describing an AI/ML medical device, please provide that, and I would be able to answer your questions.

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Eisertech, LLC Temporary Fixation Pins are indicated for the following:

• guide wire for osteosynthesis implants

• accessories for external fixation (Steinmann Pin)

• application as implant according to the principles of fracture management

The Eisertech, LLC Temporary Fixation Pins are indicated for the fixation of bone fractures, fusion of joints or bone reconstructions, or as guide pins for insertion of other implants. The Temporary Fixation Pins are offered in a variety of lengths, diameters, tip styles, and threading. The devices are made of either 17-4 stainless steel per ASTM F138 or titanium alloy (Ti-6Al-4V-ELI) per ASTM F136. The devices are delivered non-sterile and have to be sterilized before use. After fracture healing the implants have to be removed.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device performance:

The provided document is a 510(k) summary for a medical device (Temporary Fixation Pins), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the way you've described.

Therefore, most of the information you've requested regarding acceptance criteria, study design, sample sizes, ground truth, experts, and comparative effectiveness studies is not present in this type of document because such studies are generally not required for 510(k) clearances.

However, I can extract the relevant information and explain why other parts are missing based on the nature of a 510(k) submission.

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

Explanation: In a 510(k) submission like this, the "acceptance criteria" for the device's performance are implicitly met by demonstrating substantial equivalence to a predicate device that has already established safety and effectiveness. No new, specific performance acceptance criteria are defined for this particular submission.

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

• Sample Size for Test Set: Not applicable. No performance study was conducted.
• Data Provenance: Not applicable. No performance study was conducted.

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)

• Number of Experts: Not applicable. No performance study was conducted.
• Qualifications of Experts: Not applicable. No performance study was conducted.

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

• Adjudication Method: Not applicable. No performance study was conducted.

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

• MRMC Study: No. This is a physical medical device (fixation pins), not an AI/software device that would involve human readers or AI assistance.
• Effect Size: Not applicable.

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

• Standalone Study: No. This is not an algorithm or AI device.

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

• Type of Ground Truth: Not applicable. No performance study was conducted in this 510(k) submission. The "ground truth" here is the prior FDA clearance of the predicate device, which established its safety and effectiveness.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. No AI/software device or training data set is involved.

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

• Ground Truth Establishment for Training Set: Not applicable. No AI/software device or training data set is involved.

Summary of Device and Rationale from the Document:

• Device: Eisertech, LLC Temporary Fixation Pins
• Indications for Use: Guide wire for osteosynthesis implants, accessories for external fixation (Steinmann Pin), application as implant according to the principles of fracture management.
• Predicate Device: aap Implantate AG aap Wire Bone / K-Wire; Cerciage Wire, Steinmann Pin (K131459)
• Primary Argument for Substantial Equivalence: The subject device is substantially equivalent because it uses the "same materials, fall within the geometry and dimensions, and share the same intended use as previously cleared for the predicate device." It also notes that the surface treatment is identical to a reference device (K190565).
• Performance Testing: "Performance testing is not necessary and was not performed on the subject device" due to the substantial equivalence argument based on materials, geometry, dimensions, and intended use to the predicate.

In essence, this 510(k) submission is a regulatory filing arguing that the new device is sufficiently similar to an already-approved device that it does not raise new questions of safety or effectiveness, therefore eliminating the need for extensive new performance studies as would be required for a novel device or a PMA.

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Devices (K-Wires and Steinmann Pins) are intended to be used as:

• · Guide wires for osteosynthesis implants
• · Accessories for external fixation (Steinmann Pins)
• · Implants according to principles of fracture management

The SMV Scientific K-Wire and Pin consists of K-Wire and Pins in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided nonsterile. All devices are manufactured from medical grade Stainless Steel or Titanium alloys.

This document is a 510(k) clearance letter for the "SMV Scientific K-Wire and Pins." It does not contain information about a study with acceptance criteria and device performance in the context of an AI/ML device. The device described here is a physical medical device (K-wires and Steinmann pins), and its clearance is based on substantial equivalence to a predicate device, not on a performance study with acceptance criteria.

Therefore, I cannot provide the requested information. The document explicitly states:

"Testing, therefore, was not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices."

This indicates that the clearance was based on engineering analysis and comparison to a predicate device, not on a performance study that would generate the kind of data requested (acceptance criteria, reported device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.).

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The Vilex X-Fix is intended for external fixation with the following indications:

1. Stabilization of Fractures & Osteotomy
2. Rear & Mid-foot Foot Arthrodesis
3. Adult and Pediatric Leg Lengthening
4. Correction of Bone Deformity in Upper & Lower Extremities

This submission includes medical grade stainless steel half pins and wires coated with Hydroxyapatite (HA). They are intended to be used with external fixation systems.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "Ultima HA Coated Half Pins And Wire" manufactured by Vilex in Tennessee, Inc. It details the substantial equivalence review process, but it DOES NOT contain information about specific acceptance criteria, a study that proves the device meets those criteria, or performance metrics.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Ultima HA Coated Half Pins and Wires by Vilex, K132820). The rationale for substantial equivalence is based on:

• Indications for Use: The current device has the same intended uses as the predicate.
• Technological Characteristics: The device has similar technological characteristics (e.g., material, sizes, design) to the predicate.
• Material of Construction: The materials used are the same.
• Analysis Data: General analysis data is mentioned as supporting safety and effectiveness.

Therefore, I cannot provide the requested information about acceptance criteria and device performance as it is not present in the provided text.

Based on the provided text, I can only provide the following:

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

• Not Available. The document does not specify quantitative acceptance criteria or reported device performance metrics. It establishes substantial equivalence by comparing the device's characteristics and indications for use to a predicate device.

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

• Not Available. No specific test set, sample size, or data provenance is mentioned for performance evaluation in this 510(k) summary. The document relies on similarity to a predicate device and material/analysis data.

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)

• Not Applicable. No ground truth establishment related to a test set for performance evaluation is mentioned.

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

• Not Applicable. No test set or related adjudication method is mentioned.

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

• Not Applicable. This device is a medical implant (bone fixation fastener), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is irrelevant to this submission.

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

• Not Applicable. This device is a physical medical implant, not an algorithm.

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

• Not Available/Not Applicable. The concept of "ground truth" as it applies to performance evaluation of a diagnostic or AI device is not relevant here. The substantial equivalence relies on demonstrating that the device is as safe and effective as a legally marketed predicate through design, material, and intended use similarities.

8. The sample size for the training set

• Not Applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set.

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

• Not Applicable. As above, no training set or ground truth for it is relevant to this device.

Summary of what is available from the document:

• Device Name: Ultima HA Coated Half Pins and Wires
• Predicate Device: Ultima HA Coated Half Pins and Wires by Vilex (K132820)
• Basis for Substantial Equivalence: Similar indications for use, technological characteristics (materials, sizes, design), and general analysis data.
• Indications for Use:
  1. Stabilization of Fractures & Osteotomy
  2. Rear & Mid-foot Foot Arthrodesis
  3. Adult and Pediatric Leg Lengthening
  4. Correction of Bone Deformity in Upper & Lower Extremities
• Material: Medical grade stainless steel coated with Hydroxyapatite (HA).
• Safety Testing: Pyrogen testing was conducted and confirmed the device is non-pyrogenic.

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