AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5

K133675 · Aap Implantate AG · HRS · Jan 23, 2014 · Orthopedic

Device Facts

• Record ID: K133675
• Device Name: AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5
• Applicant: Aap Implantate AG
• Product Code: HRS · Orthopedic
• Decision Date: Jan 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 is indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.

Device Story

The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 is a metallic bone fixation system used by surgeons for internal fixation of distal tibia fractures, osteotomies, and non-unions. The system comprises bone plates and screws; when used with locking screws, it functions as an internal fixator. The device is implanted during orthopedic surgery to stabilize bone fragments, providing structural support to facilitate healing, particularly in patients with osteopenic bone.

Clinical Evidence

Bench testing only. Implant fatigue tests with progressive loadings were performed to represent worst-case clinical scenarios. Results demonstrated mechanical performance equivalent to the predicate device.

Technological Characteristics

Metallic bone fixation plate and screw system. Material: Ti6Al4V (ASTM F136 or ISO 5832-3). Features locking screw capability for internal fixation. Dimensions/form factor: Distal Anterolateral Tibia Plate 3.5 with associated 3.5mm cortical screws.

Indications for Use

Indicated for patients requiring internal fixation for fractures, osteotomies, and non-unions of the distal tibia, including those with osteopenic bone.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plates (K092812)

Submission Summary (Full Text)

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oop Implantate AG
aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 ﻧ

K133675 page 1 of 2

## Summary of Safety and Effectiveness

| Sponsor: | aap Implantate AG<br>Lorenzweg 5<br>D-12099 Berlin Germany<br>JAN 2 3 2014 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Dr. Christian Zietsch<br>Phone: [phone]<br>Fax: [phone] - 111 |
| Date | November 25 / 2013 |
| Trade Name: | aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 |
| Common Name: | Distal Anterolateral Tibia Plate |
| Classification Name and<br>Reference: | 21 CFR 888.3030 Single/multiple component metallic<br>bone fixation appliances and accessories - Class II |
| Product Code | HRS |
| Predicate device: | Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal<br>Tibia Plates under the pre-market notification K092812<br>(May 11, 2010) |
| Device Description: | The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5<br>consists of bone plates and bone screws, to be implanted<br>by a surgeon in order to achieve an internal fixation of bone<br>fragments typically after fractures. If the plates are used in<br>conjunction with locking screws, a so called internal fixator<br>will be realized (internal fixation). |
| | The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5<br>consists of: |
| | LOQTEQ® Distal Anterolateral Tibia Plate 3.5 (left<br>and right)<br>to be used with LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 3.5, self-tapping LOQTEQ® Cortical Screw 3.5, small head, T15, self-tapp. Cortical Screw 3.5, small head, self-tapping |
| Material: | Implants are made of Ti6A14V (ASTM F136 or ISO 5832-3) |
| Indications: | The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 is<br>indicated for fractures, osteotomies, and non-unions of the<br>distal tibia, especially in osteopenic bone. |

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Substantial Equivalence The Substantial Equivalence of the new device and the predicate device is based on similar intended use, design, functionality, components and materials in use.

> Documentation including mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission.

### Performance Data (Non-Clinical and / or Clinical):

Non-clinical tests have been performed and show the effectiveness and safety of the device.

#### Summary of Non-clinical tests:

#### Type of test:

Implant Fatigue tests with progressive loadings, representing worst case scenario with respect to clinical use.

#### Assessment of test results:

Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.

Documentation regarding the mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

#### Public Health Service

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

January 23, 2014

aap Implantate AG Dr. Christian Zietsch Manager, Regulatory Affairs Lorenzweg 5. D-12099 Berlin GERMANY

Re: K133675

Trade/Device Name: aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 25, 2013 Received: November 29, 2013

Dear Dr. Zietsch:

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. Drue, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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### *Page 2 - Dr. Christian Zietsch

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

## Ronald Nean -S for

- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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aop Implantate AG aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 : - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

### Indications for Use Statement

510(k) Number (if known): K133675

## Device Name: aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5

## Indications for Use:

The aap LOQTEQ® Distal Anterolateral Tibia Plate 3.5 is indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabeth ank -S

Division of Orthopedic Devices

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