(163 days)
Device Name: Auxein Nailing System are categorized to the following system:
- Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Gamma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System
INDICATION FOR USE:
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AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of the proximal and distal tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.
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AUXEIN Brand of Expert Femoral Nailing System -is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
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AUXEIN Brand of Gamma Nailing System -The Gamma Nail with Anti -Rotation Screw is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
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AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended to treat stable and unstable proximal femoral fracture including Pertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.
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The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the important. This includes upper extremity fractures in all patients and lower extremity fractures in children above the age of 6 years and any patient below 65 kg. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures.
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AUXEIN Brand of Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.
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AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.
An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body.
The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136).
Auxein Brand of Expert Tibia Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 8mm to 12mm; the length varies from 255mm. The screw implants are in corresponding diameter of 4.4mm & 4.8mm diameters with lengths varying as per the requirements and minimum length: 24mm to maximum length 90mm.
Auxein Brand of Expert Femoral Nail system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking screw & Anti-rotation screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones.The diameter of the nails varies from 9mm to 13mm; the length varies from 320mm to 440mm.The screw implants are in corresponding diameter of 4.8mm, 6.4mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 25mm to maximum length 130mm.
Auxein Brand of Ga-mma Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, Inner screw, locking bolts, Anti-rotation screw & Cephalic screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9mm to 13mm; the length varies from 180mm. The screw implants are in corresponding diameter of 4.8mm, 6.4mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 26mm to maximum length 120mm.
Auxein Brand of Humeral Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking bolt, compression screw, and proximal screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 6mm to 9mm; the length varies from 180mm to 320mm. The screw implants are in corresponding diameter of 3.5mm & 4.5mm diameters with lengths varying as per the requirements and minimum length: 20mm to maximum length 70mm.
Auxein Brand of AJAX Advance Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps, locking bolts, Cephalic screw, Ajax Blade, and inner screw of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9mm to 12mm: the length varies from 170mm to 420mm.The screw implants are in corresponding diameter of 4.9mm & 10.5mm diameters with lengths varying as per the requirements and minimum length: 26mm to maximum length 120mm.
Auxein Brand of Elastic Nailing system consists of various shapes and sizes of sterile nails featuring end caps of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 1.5mm to 4.0mm; the total length of 440mm. The end caps are in corresponding diameter ranges from 1.5mm to 4.0mm diameters with length of 14mm & 25mm.
Auxein Brand of Retrograde Nailing system consists of various shapes and sizes of sterile nails featuring proximal & distal holes, end caps & locking bolts of different sizes. The nails and screws are fabricated from titanium. The system contains several modules based on the size of the device and application site such as fixation/reconstruction of bones. The diameter of the nails varies from 9.5 to 12mm; the length varies from 180mm to 360mm. The screw implants are in corresponding diameter of 5.0mm diameters with lengths varying as per the requirements and minimum length: 32mm to maximum length 80mm.
Auxein Nailing System covered same products as of covered in K192003. In this addition Auxein Nailing System is offering sterile version of the nailing devices.
The device is made from a Titanium alloy, Ti-6Al-4V ELI (ASTM F136).
However, we are adding a new device i.e. Ajax Blade in this submission. The associated Instruments with the newly added device are tabulated below.
- Inner Screwdriver, Hex 4.0mm
- Inner Screw Holder, Hex 4.0mm
- Container for AJAX Cephalic Screw Instrument Set
These implants will be supplied in Sterile State (Gamma Irradiation) Only.
The provided text is a 510(k) summary for the Auxein Nailing System, which is a medical device. This type of document is for premarket notification of a device to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It focuses on comparing the new device to existing ones based on design, materials, and intended use, and generally does not contain information about clinical studies with human participants, AI algorithms, or detailed performance metrics like sensitivity/specificity derived from such studies.
Therefore, many of the requested items, which are typical for studies involving AI algorithms or comparative effectiveness of diagnostic devices, are not present in this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance beyond compliance with material and performance standards. The "performance" is demonstrated through adherence to these standards and comparison to a predicate device.
| Acceptance Criteria (Standards Adherence) | Reported Device Performance (Compliance) |
|---|---|
| Material Standards: | |
| ASTM F 136 (Wrought Titanium Alloy) | Complied with standard (material verified) |
| ASTM F 899-12 (Wrought Stainless Steels for surgical instruments) | Complied with standard (material verified) |
| Performance Standards: | |
| ASTM F 543-17 | Device's performance demonstrated against this standard |
| ASTM F1264 (Screw Cut-Out Test - specifically for Ajax Blade) | Device's performance demonstrated against this standard |
| ASTM F384 | Device's performance demonstrated against this standard |
| Custom Fatigue Testing | Device's performance demonstrated against this testing |
| Sterilization Standards: | |
| ASTM F1980 (Accelerated Aging of Sterile Barrier Systems) | Sterilization method validated using this standard |
| ISO 11737-2:2019 (Tests of sterility) | Sterilization method validated using this standard |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The testing described is non-clinical (material and mechanical), not involving human patient 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)
This information is not applicable and not provided. "Ground truth" in the context of clinical expert consensus is not relevant to the non-clinical testing performed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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 is not an AI device. No MRMC study was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI device. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing is compliance with established engineering and material standards (e.g., ASTM F136 for material composition, ASTM F543 for mechanical properties).
8. The sample size for the training set
This information is not applicable and not provided. There is no AI training set for this device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no AI training set for this device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.