LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE

K132787 · Aap Implantate AG · HRS · Dec 24, 2013 · Orthopedic

Device Facts

• Record ID: K132787
• Device Name: LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE
• Applicant: Aap Implantate AG
• Product Code: HRS · Orthopedic
• Decision Date: Dec 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The aap LOQTEQ® Elbow System is indicated for: - intra-articular fractures of the distal Humerus . - supracondylar fractures of the distal Humerus . - osteotomies, and non-unions of the distal Humerus .

Device Story

System consists of metallic bone plates and screws for internal fixation of distal humerus bone fragments; surgeon-implanted; plates used with locking screws function as internal fixator; provides mechanical stabilization of fractures; facilitates bone healing.

Clinical Evidence

Bench testing only. Static and dynamic system tests performed representing worst-case clinical scenarios to demonstrate mechanical performance, safety, and effectiveness.

Technological Characteristics

Implants made of Ti6Al4V (ASTM F136 or ISO 5832-3). System includes distal dorsolateral and medial humerus plates, cortical screws (2.5mm, 2.7mm, 3.5mm), and instrumentation. Mechanical fixation device.

Indications for Use

Indicated for patients with intra-articular fractures, supracondylar fractures, osteotomies, and non-unions of the distal humerus.

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) 3.5 mm LCP Distal Humerus System (K033995)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized image of three faces in profile, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

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

March 24, 2015

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

Re: K132787 Trade/Device Name: aap LOQTEQ® Elbow System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: September 26, 2013 Received: October 7, 2013

Dear Dr. Zietsch:

This letter corrects our substantially equivalent letter of December 24, 2013.

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

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Page 2 - Dr. Christian Zietsch

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 forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free 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" (21CFR 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 vours.

Lori A. Wiggins -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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## Indications for Use Statement

510(k) Number (if known): K132787

## Device Name: aap LOQTEQ® Elbow System

### Indications for Use:

The aap LOQTEQ® Elbow System is indicated for:

- intra-articular fractures of the distal Humerus .
- supracondylar fractures of the distal Humerus .
- osteotomies, and non-unions of the distal Humerus .

| Prescription Use | X |
|-----------------------------|------------------------|
| (Part 21 CFR 801 Subpart D) | AND/OR |
| Over-The-Counter Use | (21 CFR 801 Subpart C) |

#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132787

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# Summary of Safety and Effectiveness

| Sponsor: | aap Implantate AG<br>Lorenzweg 5<br>D-12099 Berlin Germany |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Dr. Christian Zietsch<br>Phone:[phone]<br>Fax: [phone] - 111 |
| Date | March / 12 / 2015 |
| Trade Name: | aap LOQTEQ® Elbow System |
| Common Name: | Distal Humerus System |
| Classification Name and<br>Reference: | 21 CFR 888.3030 Single/multiple component metallic<br>bone fixation appliances and accessories – Class II and<br>21 CFR 888.3040 Smooth or threaded metallic bone fixa-<br>tion fastener - Class II |
| Device Product Code and<br>Panel Code: | Orthopedics/87/ HRS: Plate, Fixation, Bone<br>Orthopedics/87/ HWC: Screw, Fixation, Bone |
| Predicate device: | Synthes (USA) 3.5 mm LCP Distal Humerus System under<br>the premarket notification K033995 (Mar 1, 2004) |
| Device Description: | The aap LOQTEQ® Elbow System consists of bone plates<br>and bone screws, to be implanted by a surgeon in order to<br>achieve an internal fixation of bone fragments of the distal<br>humerus. If the plates are used in conjunction with locking<br>screws, a so called internal fixator will be realized (internal<br>fixation).<br><br>The aap LOQTEQ® Elbow System consists of:<br>LOQTEQ® Distal Dorsolateral Humerus Plate (left and right) LOQTEQ® Distal Medial Humerus Plate (left and right) LOQTEQ® Cortical Screw 2.7, small head T8, self-tapping Cortical Screw 2.5, small head T8, self-tapping LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 3.5, self-tapping Set of Instruments aap LOQTEQ® Elbow System |
| Material: | Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3) |
| Indications: | The aap LOQTEQ® Elbow System is indicated for:<br>- intra-articular fractures of the distal Humerus<br>- supracondylar fractures of the distal Humerus |
| | |
| Substantial Equivalence | The Substantial Equivalence of the new device and the<br>predicate device is based on similar intended use, design,<br>functionality, components and materials in use. |
| | Documentation including mechanical testing to show the<br>substantial equivalence and safety and effectiveness has<br>been provided with this submission. |
| Performance Data<br>(Non-Clinical and /<br>or Clinical): | Non-clinical tests have been performed and show<br>the effectiveness and safety of the device. |
| | Summary of Non-clinical tests: |
| | Type of test:<br>Static and dynamic system tests, representing worst case<br>scenario with respect to clinical use. |
| | Assessment of test results:<br>Substantial equivalence with respect to the mechanical<br>performance of the aap system could be stated due to the<br>test results gained. The subject device is safe and effec- |

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

tive, and whose performance meets the requirements of its

pre-defined acceptance criteria and intended uses.