(421 days)
The Orthodontic Bone Anchor (OBA) System screw anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adolescents greater than age 12 and adults.
The Orthodontic Bone Anchor (OBA) System plate anchors are intended to be implanted intraorally and used as an anchor for orthodontic procedures in adults.
The Synthes (USA) Orthodontic Bone Anchor System is intended to be implanted intraorally and used as an anchor for orthodontic procedures. The System includes screw anchors, plate anchors, instruments, and a module case for storage and sterilization.
Screw Anchors
The screw anchor portion of the system consists of 1.55 mm self-drilling and self-tapping screw anchors which incorporate a non-threaded gingival collar beneath the screw head to protect the soft tissue. Once implanted, orthodontic appliances such as archwires, elastics, and springs can be attached to the head of the anchor.
The screw anchors are manufactured from titanium alloy (Ti-6Al-7Nb).
Plate Anchors
The plate anchor portion of the system consists of T-shaped plate anchors which are attached to the bone via 1.55 mm cortex screws and 1.85 mm emergency screws. The plate anchors are offered in three designs (mesh, bracket, and domed) to allow attachment of orthodontic devices such as brackets, archwires, elastics, and springs
The plate anchors are manufactured from commercially pure titanium. The screws used to fix the plate anchors to the bone are manufactured from titanium alloy (Ti-6Al-7Nb)
The provided text describes a 510(k) premarket notification for the Synthes Orthodontic Bone Anchor System. This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a detailed study with specific performance metrics against those criteria.
Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth information) cannot be extracted from this document as this type of information is generally not required or provided in a 510(k) summary for mechanical devices like bone anchors.
The document primarily states:
- Non-Clinical Testing Data: "The Synthes Orthodontic Bone Anchor System was tested for resistance to pullout under clinical loads by means of axial, shear, and cantilever loading. Screws were also tested for insertion torque, removal torque, and yield and failure torque."
- Substantial Equivalence: "The proposed devices are similar to the predicate devices identified above in terms of indications, principles of operation (provide fixed anchorage for orthodontic movement of teeth), device design/geometry, and materials. Information presented supports substantial equivalence."
This indicates that mechanical testing was performed, but specific acceptance criteria and the quantitative results validating against them are not detailed in the provided summary. The focus is on demonstrating that the new device performs similarly to existing, legally marketed devices.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.