(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.
{0}------------------------------------------------
SEP 2 0 2005 મ BioHorizons Implant Systems, Inc. HA-Coating Maximus™ 3.0 & OS Special 510(k): Device Modification August 26, 2005
510(k) Summary 21 CFR 807.92
Date: Official Contact: Manufacturer:
August 26, 2005 Winston Greer, Vice-President, QA & RA BioHorizons Implant Systems, Inc. One Perimeter Park South Suite 230 South Birmingham, AL 35243 Phone: (205) 967-7880 Fax: (205) 870-0304
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
Predicate devices are:
-
- The BioHorizons Dental Implant System, a screw-type endosseous implant manufactured and distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 510(k) number K960026, concurrence date March 28, 1996.
-
- BioHorizons the Maestro System™ 3.0mm diameter implant, a screw-type endosseous implant manufactured and distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 510(k) number K032351, concurrence date October 21, 2003.
-
- BioHorizons Maximus OS (Overdenture System) Implant, a screw-type endosseous implant manufactured and distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 510(k) number K041938, concurrence date July 22, 2004.
Device Description
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.
{1}------------------------------------------------
BioHorizons Implant Systems, Inc. HA-Coating Maximus™ 3.0 & OS Special 510(k): Device Modification August 26, 2005
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 following table provides a summary of the proposed catalog item or reference numbers by implant length and collar height.
| Length(mm) | CatalogREF Number | |
|---|---|---|
| Maximus 3.0mm implant | Maximus OS implant | |
| 12 | 3012D4 | 3012OS2H |
| 12 | 3012OS4H | |
| 15 | 3015D4 | 3015OS2H |
| 15 | 3015OS4H | |
| 18 | 3018D4 | 3018OS2H |
| 18 | 3018OS4H |
Intended Use
で
The BioHorizons Maximus 3.0mm implant may be used:
- (1) as an artificial 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 occlusion.
- (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.
{2}------------------------------------------------
BioHorizons Implant Systems, Inc. HA-Coating Maximus™ 3.0 & OS Special 510(k): Device Modification August 26, 2005
The BioHorizons Maximus OS implant may be used for denture stabilization using The Diononzons Maximus OO Implant may oo as as a subla. The implants may be restored after a period of time or placed in immediate function.
Technological Characteristics
ollulcal Sharacteristics
The fundamental scientific technology of the device is identical to the referenced in The fundatherital solements, suppliers, processing, packaging and sterilization predicate devices. An materials, cappilere, procession prosecures Maximus 3.0mm and OS methods remain the Same do for the productions 3.0 and OS implants are substantially implant to all features of the predicate devices which could affect safety or equivalorit to an roaterse of the pilarities in design, material and intended use.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized human figure with three flowing lines extending from the figure's head, resembling a bird in flight.
SEP 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Winston Greer Vice-President, QA & RA BioHorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230 Birmingham, Alabama 35243
Re: K052419
K032417
Trade/Device Name: BioHorizons Maximus 3.0mm and OS Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 26, 2005 Received: September 2, 2005
Dear Mr. Greer:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your because on (4) + = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = referenced adove and have determined and as neally marketed predicate devices marketed in indications for use stated in the chelosary to eag.
interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate commerce prior to way 20, 1778, the children with the provisions of Amendments, of to devices mat nave obcit (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosmette 100 (10) -------------------------------------------------------------------------------------------------------------------------------approval application (1 Mrx). Four 110), Pour Styles provisions of the Act include controls provisions of the Fiel. The gasting of devices, good manufacturing practice, requiremonts for anitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (soc above) into enontrols. Existing major regulations affecting (PMA), it may be subject to submitter. Forel Regulations, Title 21, Parts 800 to 898. In the Architector I your device can be found in the South 11.
addition, FDA may publish further announcements concerning your device in the Federal Register.
{4}------------------------------------------------
Page 2 - Mr. Greer
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issuance of a subscribes with other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that FDA has made a decembination and your and your and miter Federal agencies.
of the Act or any Federal statutes and regulations absortunited to: registration of the Act or any Federal statues and reginations, but not limited to: registration
You must comply with all the Act step of a condiness and menufacturing practice You must comply with an the Act 3 requirences, introducing, cool manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practic and listing (21 CFR Part 807), labelling (21 cm Party are (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); of the requirements as set forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k)
the success of the support of a line of select stick aggivelence of way device This letter will allow you to begill maticemig your atial equivalence of your device to a
premarket notification. The FDA finding of substantial equivalers and thus, ne premarket notification. The PDA intellig of Sabbanials of Any Survey and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your device on our accoming of garden one the regulation please contact the Office of Compilance at (210) 270-578 Part 807.97). You
entitled, "Misbranding by reference to premarket notification wades the Act from the entifled, "Misbranding by lefelect to premation on your responsibilities under the Act from the may obtain other general information on your copy cossumer Assistance at its toll-free
Division of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sinan Manufacturers, 143-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
BioHorizons Implant Systems, Inc. Blor onzons Implant Systems, ................................................................................................................................................. August 26, 2005
Page 1 of 1
510(k) Number: K052419
Device Name: BioHorizons Maximus 3.0mm and OS Implants
Indications for Use:
The BioHorizons Maximus 3.0 Implants may be used (1) as a nrtificial root structure for The BloHofizons Maximus 5.0 Implants may bo assort and maxillary lateral
single tooth replacement of mandibular central and laith tomperary prosthesis that is single tooth replacement of mandibular ocurated with a temporary prosthesis that is
incisors. The implant may be immediately restored with a temporary prosthesis for includio. The implair may be inimodiating rogether as an artificial root structure for not in functional occusion, (2) when Spiritoritors. The implants may be restored after a
multiple tooth replacement of mandibular incisors. The implants may multiple multiple tooln replacement of manabolial the stablization using multiple
period of time or placed in immediate function; (3) for dentures ater a period of time of placed in inimodiate fansila. 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 The Blorionzons Maximus OO Implants may be restored after a period of time or placed in immediate function.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susun Russe
ിഴിടിon Sign-Off
Division of Anesthesiology, General Hospital, Infection Control, Dental Devi
510(k) Number. T152419
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
§ 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.