(252 days)
The Cannulated NuGen™ FX Screw is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or condylar grafts within the condylar aspects of the upper extremity, ankle and foot, in the presence of appropriate brace and/or immobilization. Specifically, it is intended for phalangeal fusion and fracture, metacarpal fusion and fracture, carpal fusion and fracture, wrist arthrodesis, Distal radius fractures, olecranon fractures, radial head fractures, humeral condylar fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies and correction of hallux valgus.
The Cannulated NuGen™ FX Screw is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except those in the hand and foot) and proximal femoral fractures. 2) Situations where internal fixation is otherwise contraindicated, e.g.. active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism). 3) Highly comminuted fractures, which would not be appropriate for fixation with metallic screws. 4) Patients with suspected or known allergy to the implant material.
The device description of the Cannulated NuGen™ FX Screw biodegradable bone fixation screw is as follows.
- Composed of poly-L/D-lactide copolymer
- Lengths 14 70mm
- Diameters 3.5mm with cannulation for 1.2mm K-wire and 4.5 mm with cannulation for 1.6mm K-wire.
- Fully and partly threaded models
The only modifications that were made are:
- Amendment of screw models with cannulation
- Amendment of suitable instruments into instrumentation accordingly.
This submission is a 510(k) premarket notification for a medical device called the Cannulated NuGen™ FX Screw. As such, it focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical studies with acceptance criteria and detailed performance reporting as would be seen in a PMA (Premarket Approval) application.
Therefore, many of the requested categories of information for a study and acceptance criteria are not applicable or available within this 510(k) submission. 510(k)s typically rely on design principles, material equivalence, and potentially limited bench testing rather than extensive clinical trials.
Here's the breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not Applicable/Available: This document does not present formal acceptance criteria or detailed device performance metrics from a study in the way a clinical trial would. The basis of this 510(k) is substantial equivalence to predicate devices rather than meeting specific performance thresholds in a de novo study. The "performance" demonstrated here is the similarity to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable/Available: No test set in the sense of a clinical trial or large-scale performance evaluation is described. The submission focuses on product modifications and demonstrating equivalence to existing cleared devices. Data provenance is not relevant as no specific patient data is analyzed or referenced for a test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable/Available: Ground truth is not established in this context. The submission relies on regulatory judgment of substantial equivalence based on device design, materials, and intended use, not expert consensus on diagnostic or prognostic outcomes.
4. Adjudication Method for the Test Set:
- Not Applicable/Available: No test set means no adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable/Available: This type of study is for evaluating human performance, often in diagnostic imaging, with and without AI assistance. This device is an orthopedic implant, so an MRMC study is entirely irrelevant.
6. Standalone (Algorithm Only) Performance:
- Not Applicable/Available: This device is a physical implant, not an algorithm, so standalone performance is not applicable.
7. Type of Ground Truth Used:
- Not Applicable/Available: As mentioned, no ground truth is established as part of this submission. The "truth" in a 510(k) is whether the new device is substantially equivalent to existing, legally marketed predicate devices.
8. Sample Size for the Training Set:
- Not Applicable/Available: This device is not an AI/ML algorithm or a diagnostic tool that relies on a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable/Available: As above, no training set.
Summary of Relevant Information from the K033447 Submission:
This 510(k) submission (K033447) by Linvatec Biomaterials Ltd. for the Cannulated NuGen™ FX Screw seeks to demonstrate substantial equivalence to several predicate devices, primarily existing NuGen™ FX Screw models (K012001, K023022) and other Bionx Implants Inc. Biofix® and SmartScrew™ products.
The core argument for equivalence is based on the following similarities to the cleared predicate NuGen FX Screw models:
- Same indicated use
- Same operating principle
- Same basic design of thread
- Same basic dimensions
- Manufactured by machining
- Packaged and sterilized using the same materials and processes
- Same shelf life
The only modifications introduced in this new device are:
- Amendment of screw models with cannulation
- Amendment of suitable instruments into instrumentation accordingly
The FDA's review letter (pages 2-3 of the provided text) confirms that they found the device substantially equivalent for the stated indications for use. This means FDA determined that the device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).
In essence, the "acceptance criteria" here implicitly revolve around demonstrating that the new device, despite minor modifications (cannulation), does not raise new questions of safety or effectiveness when compared to its existing, predicate counterparts. The "study" is the submission's argument and evidence of this substantial equivalence based on design, materials (poly-L/D-lactide copolymer), and manufacturing processes.
§ 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.