Osseointegrated Fixtures

K161548 · Southern Implants (Pty), Ltd. · FZE · Dec 1, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161548
• Device Name: Osseointegrated Fixtures
• Applicant: Southern Implants (Pty), Ltd.
• Product Code: FZE · General, Plastic Surgery
• Decision Date: Dec 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3680
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Southern Implants Osseointegrated Fixtures are indicated for the attachment of an external aesthetic restoration prosthesis for the restoration of a physical defect when other means of attachment are inadequate. The endosseous implant provides the bone anchorage for the prosthetic attachment. These devices are in the maxillo-craniofacial region (including ear, nose and eye).

Device Story

System comprises endosseous, screw-type, self-tapping implants made of commercially pure titanium; includes drills, abutments, placement tools, and laboratory components. Implants placed in bone to osseointegrate; provide mechanical anchorage for external aesthetic prostheses. Used in maxillo-craniofacial region. Physician-operated; provides stable base for prosthetic retention where adhesives or suction fail. Benefits patient by enabling secure, long-term attachment of cosmetic restorations, improving quality of life for those with physical defects.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance established through mechanical testing, sterilization validation (ISO 11137, ISO 11737), biocompatibility testing (ISO 10993), and packaging validation (ASTM D4169, F1929, F88, F1980).

Technological Characteristics

Materials: Commercially pure titanium, wrought titanium 6-Al-4V alloy (ISO 5832-3, ASTM F136, ASTM F67), stainless steel (ASTM E899). Design: Solid, screw-type, self-tapping endosseous implants with moderately rough surface. Accessories: Drills, abutments, placement tools. Sterilization: Radiation (ISO 11137).

Indications for Use

Indicated for patients requiring attachment of external aesthetic prostheses for physical defect restoration in the maxillo-craniofacial region (ear, nose, eye) when other retention methods (adhesives/suction) are inadequate.

Regulatory Classification

Identification

A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

Predicate Devices

• NSI Hexed and Non-Hexed Implant System (K020617)
• NSI Hexed and Non-Hexed Implant System (K003620)
• Nobel Biocare Endosseous Implants (Maxillofacial Indications) (K090630)
• Straumann Extraoral Implant System (K990458)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 1, 2016

Southern Implants % Ms. Yolanda Smith Smith Associates 1468 Harwell Ave Crofton, Maryland 21114

Re: K161548

Trade/Device Name: Osseointegrated Fixtures Regulation Number: 21 CFR 878.3680 Regulation Name: Nose Prosthesis Regulatory Class: Class II Product Code: FZE Dated: November 1, 2016 Received: June 3, 2016

Dear Ms. Smith:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K161548

Device Name Osseointegrated Fixtures

#### Indications for Use (Describe)

Southern Implants Osseointegrated Fixtures are indicated for the attachment of an external on prosthesis for the restoration of a physical defect when other means of attachment are inadequate. The endosseous implant provides the bone anchorage for the prosthetic attachment. These devices are in the maxillo-craniofacial region (including ear, nose and eye).

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CER 801 Subpart D) | <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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P.O. Box 605 Irene 0062 South Africa Tel: [phone] Fax: [phone]

# Osseointeqrated Fixtures 510(k) Application

# SECTION 5 - 510(k) Summary

#### Submitter

Southern Implants (Pty) Ltd. 1 Albert Road Irene 0062 South Africa Tel: [phone] Fax: [phone]

#### Contact person

Miss Lauranda Breytenbach [phone] [e-mail]

#### Date prepared: December 1, 2016

#### Name of the device

| Trade name: | Osseointegrated Fixtures |
|----------------------|--------------------------------------------|
| Common name: | Implants for prosthetic retention External |
| Classification name: | Nose prosthesis |
| Regulation Number: | 21 CFR 878.3680 |
| Product Code: | FZE |
| Device Class: | Class II |

#### Legally marketed devices to which equivalence is claimed (predicate devices)

| Manufacturer | Device Name | K Number |
|-----------------------------------------------------|------------------------------------------------------------------|----------|
| NSI, Inc.<br>(Manufactured by Southern<br>Implants) | NSI Hexed and Non-Hexed Implant System | K020617 |
| NSI, Inc.<br>(Manufactured by Southern<br>Implants) | NSI Hexed and Non-Hexed Implant System | K003620 |
| Nobel Biocare | Nobel Biocare Endosseous Implants<br>(Maxillofacial Indications) | K090630 |
| Straumann USA | Straumann Extraoral Implant System | K990458 |

#### Device Description

The device 'Osseointegrated Fixtures' refers to a system involving endosseous implants and their accessories. The endosseous implants are solid, screw-type, self-tapping implants made from commercially pure titanium, with the same enhanced surface as the Southern Implants dental implants. The accessories include drills to prepare the site, abutments and attachments to aid the prosthetic retention, placement tools, instruments and laboratory components.

#### Indications for Use

Southern Implants Osseointegrated Fixtures is indicated for the attachment of an external aesthetic restoration prosthesis for the restoration of a physical defect when other means of attachment are inadequate. The endosseous implant provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye).

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K161548 P.O. Box 605 South Africa Tel. [phone] Fax: [phone]

## Osseointearated Fixtures 510(k) Application

# SECTION 5 - 510(k) Summary

#### Intended use

The implants are placed in bone and are intended to osseointegrate to provide an attachment for an external aesthetic restoration prosthesis. The device provides a solution for the prosthetic restoration of a cosmetic defect when other means (such as adhesives or suction) are inadequate to retain the prosthesis.

#### COMPARISON OF TECHNICAL CHARACTERISTICS

#### Substantial equivalence

This device and the predicates are all used in the same way: they are screwed into bone where they are intended to osseointegrate to provide an attachment for a prosthesis. The material for all implants is titanium and the operating principle which is primary fixation by means of an external thread, and permanent fixation by osseointegration are the same. Torque for placement is transferred through the connection interface in the implants. Osseointegration is enhanced by means of a moderately rough titanium surface

In comparison to predicates NSI Hexed and Non-Hexed Implant System (K020617 & K003620) are indicated for the attachment of dental prosthetics, and the Southern Implants Osseointegrated Fixtures are used to attach extraoral cosmetic prosthetics. Thus, it will not be subject to the kind of loads experienced by dental implants. Additionally, the extraoral environment is typically biologically cleaner than the oral environment.

The Nobel Biocare Endosseous Implants (Maxillofacial Indications) (K090630) and Straumann Extraoral Implant System are indicated for the attachment of an external aesthetic restoration prosthesis in the maxillofacial region. In comparison, the use of the Southern Implants Osseointegrated Fixtures is not restricted to the craniofacial region. However, its use remains the same, for the mechanical retention of a cosmetic prosthesis. This device enables other external aesthetic prosthetic restorations which would benefit from the availability of bone-anchorage in the same way as maxillofacial/craniofacial prostheses do.

After safety and testing was performed, Southern Implants has concluded that the device does not introduce any significant questions of safety and is substantially equivalent to the predicate devices.

| Standard | Standard Title |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 11137-1 | Sterilization of Health Care Products – Radiation – Part 1: Requirements for<br>Development, Validation & Routine Control of a Sterilization Process for Medical<br>Devices |
| ISO 11137-2 | Sterilization of Health Care Products – Radiation – Part 1: Establishing the Sterilization<br>Dose |
| ISO 11737-1 | Sterilization of Medical Devices – Microbiological Methods – Part 1: Estimation of<br>Population of Microorganisms on Products |
| ISO 11737-2 | Sterilization of medical devices - Microbiological Methods - Part 2: Tests of Sterility<br>Performed<br>in the Validation of a Sterilization Process |
| EN 556-1 | Sterilization of Medical Devices - Requirements for Medical Devices to be designated |

Safety Testing

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K161548 P.O. Box 605 Irene 0062 South Africa Tel: [phone]
Fax: [phone]

# Osseointegrated Fixtures 510(k) Application

#### SECTION 5 - 510(k) Summary

| SECTION 5 – 510(k) Summary | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | "STERILE" - Part 1: Requirements for Terminally Sterilized Medical Devices |
| ISO 10993-1 | Biological evaluation of medical devices- part 1: Evaluation and testing within a risk<br>management process |
| ISO 14971 | Medical Devices - Application of Risk Management to Medical Devices |
| ISO 10993-5 | Biological evaluation of medical devices – Part 5; Tests for in vitro cytotoxicity |
| ISO 10993-18 | Biological evaluation of medical devices – Part 18: Chemical characterization of<br>materials. |
| ISO 11607-1 | Packaging for terminally sterilized medical devices - part 1: requirements for materials,<br>sterile barrier systems and packaging systems [including: amendment 1<br>(2014)]. (Sterility) |
| ISO 11607-2 | Packaging for terminally sterilized medical devices - part 2: validation requirements for<br>forming, sealing and assembly processes [including: amendment 1 (2014)]. (Sterility) |
| ASTM D4169-14 | Standard practice for performance testing of shipping containers and systems. (Sterility) |
| ASTM F1929-12 | Standard test method for detecting seal leaks in porous medical packaging by dye<br>penetration. (Sterility) |
| ASTM<br>F88/F88M-09 | Standard test method for seal strength of flexible barrier materials. (Sterility) |
| ASTM F1980-07 | Standard guide for accelerated aging of sterile barrier systems for medical<br>devices. (Sterility) |
| ISO 5832-<br>3:1996 | Implants for surgery -- metallic materials -- part 3: wrought titanium 6-aluminium 4-<br>vanadium alloy. (Materials) |
| ASTM F136-13 | Standard specification for wrought titanium-6 aluminum-4 vanadium ELI (extra low<br>interstitial) alloy for surgical implant applications (Uns R56401). (Materials) |
| ASTM F67-13 | Standard specification for unalloyed titanium for surgical implant applications (Uns<br>R50250, Uns R50400, Uns R50550, Uns R50700). (Materials) |
| IEC 62366-1 | Medical devices - part 1: application of usability engineering to medical<br>devices. (General I (QS/RM)) |
| ISO 14644-1 | Cleanrooms and associated controlled environments - part 1: classification of air<br>cleanliness. (Sterility) |
| ISO 15223-1 | Medical devices - symbols to be used with medical device labels, labelling, and<br>information to be supplied - part 1: general requirements. (General I (QS/RM)) |
| BS EN 1041 | Information supplied by the manufacturer of medical devices |
| ASTM E899-12h | Standard Specification for Wrought Stainless Steels for Surgical Instruments |

#### CONCLUSION

The technological characteristics of this device and its predicates are substantially equivalent. They are all composed of commercially pure titanium, with a moderately rough surface for osseointegration. They are all self-tapping, screw-type implants. They all have similar systems of drills, abutments, placement tools and prosthetic aids. After safety testing was performed, Southern Implants has concluded that the device does not introduce any significant questions of safety and is substantially equivalent to the predicate devices.