(18 days)
The BioHorizons Maximus 3.0 Implants may be used (1) as a nrtificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occusion, (2) when Splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function; (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.
The BioHorizons Maximus OS Implants may be used for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.
The BioHorizons Maximus 3.0mm and OS implants are machined titanium, screw-form implants supplied in lengths of 12mm, 15mm and the Maximus OS implant is further supplied with tissue collar heights of 2mm and 4mm, available with each length. Implant raw material is titanium alloy as specified in ASTM F 136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
The device is further processed by treating the surface with Hydroxylapatite (HA) media to promote implant fixation. The product is packaged using materials known in the to promote impropriate for medical device packaging and is provided with a minimum sterility assurance level of 10-8, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control -Radiation Sterilization.
The Maximus 3.0mm and OS implants are comprehensive systems containing implants and surgical components. The Maximus 3.0mm diameter implant may be used (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors, with or without tissue reflection; (2) when splinted indeers an an artificial root structure for multiple tooth replacement of mandibular incisors; and, (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. In single cases they may be placed in immediate function out of occlusion with a temporary prosthesis. The Maximus OS implant is a system with the implants configured specifically for use in denture stabilization; reference the Intended Use section following.
All BioHorizons implants referenced in this submission are 3.0mm in diameter with surface treatment using Hydroxylapatite coating.
The provided document is a 510(k) summary for a medical device modification (BioHorizons HA-Coating Maximus™ 3.0 & OS Special implants). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies.
Here's why and what information is present:
- 510(k) Summary Purpose: A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device) and does not require premarket approval (PMA). The primary focus is on "substantial equivalence" based on technological characteristics, intended use, and materials.
- Lack of Performance Data: 510(k) submissions typically do not require extensive clinical trial data or detailed performance metrics against pre-defined acceptance criteria in the way a PMA or a de novo submission might. Instead, they rely on demonstrating that the new device is "substantially equivalent" to existing, cleared devices.
- Focus on Substantial Equivalence: The document explicitly states: "The fundamental scientific technology of the device is identical to the referenced predicate devices. All materials, suppliers, processing, packaging and sterilization methods remain the same... The Maximus 3.0 and OS implants are substantially equivalent to all features of the predicate devices which could affect safety or equivalent to an assessment of the similarities in design, material and intended use."
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, and performance because this information is not present in the provided 510(k) summary.
The document does provide:
- Proprietary Name: The Maximus™ 3.0mm and OS Implants
- Common Name: Screw-type Dental Implant
- Classification Name: Endosseous implants, surgical components, and prosthetic attachments
- Predicate Devices:
- Device Description: Machined titanium, screw-form implants with Hydroxylapatite (HA) coating. Lengths of 12mm, 15mm, 18mm, and OS implant variations with 2mm and 4mm tissue collar heights. Material: ASTM F 136 titanium alloy.
- Intended Use:
- Maximus 3.0mm implant: Single tooth replacement (mandibular central/lateral incisors, maxillary lateral incisors, immediate restoration out of occlusion), multiple tooth replacement when splinted (mandibular incisors), denture stabilization (anterior mandible/maxilla).
- Maximus OS implant: Denture stabilization (anterior mandible/maxilla).
- Sterility: Minimum sterility assurance level of 10-8, validated in compliance to ANSI/AAMI/ISO 11137.
§ 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.