AAP LOQTEC(R) OLECRANON PLATE

K140607 · Aap Implantate AG · HRS · May 8, 2014 · Orthopedic

Device Facts

• Record ID: K140607
• Device Name: AAP LOQTEC(R) OLECRANON PLATE
• Applicant: Aap Implantate AG
• Product Code: HRS · Orthopedic
• Decision Date: May 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The aap LOQTEQ® Olecranon Plates are indicated for fixation of fractures, osteotomies and nonunions of the olecranon, particularly in osteopenic bone.

Device Story

The aap LOQTEQ® Olecranon Plate system is an internal bone fixation device consisting of metallic plates and screws. It is implanted by a surgeon to stabilize bone fragments, typically following fractures, osteotomies, or nonunions. When used with locking screws, the system functions as an internal fixator. The device is intended for use in clinical settings by orthopedic surgeons. It provides mechanical stability to the bone, facilitating healing and potentially benefiting patients by restoring structural integrity to the olecranon, especially in cases of compromised bone quality (osteopenic bone).

Clinical Evidence

Bench testing only. Mechanical performance was evaluated using customized 4-point bending tests of bone plates in accordance with ASTM F382-99 (static and dynamic testing). Results demonstrated that the device meets requirements and is substantially equivalent to the predicate systems.

Technological Characteristics

Implants are manufactured from Ti6Al4V titanium alloy (ASTM F136 or ISO 5832-3). The system includes bone plates and self-tapping cortical screws (2.5mm, 2.7mm, and 3.5mm diameters). The device functions as an internal fixator when used with locking screws. No software or electronic components are involved.

Indications for Use

Indicated for fixation of fractures, osteotomies, and nonunions of the olecranon, particularly in patients 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) 3.5mm LCP Olecranon Plates (K082807)
• Synthes (USA) Small Fragment Dynamic Compression Locking (DCL) System (K000684)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

# MAY 0 8 2014

| Sponsor: | aap Implantate AG<br>Lorenzweg 5<br>D-12099 Berlin Germany |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Dr. Christian Zietsch<br>Phone:[phone]<br>Fax: [phone] |
| Date | February 26 / 2013 |
| Trade Name: | aap LOQTEQ® Olecranon Plate |
| Common Name: | Olecranon 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) 3.5mm LCP Olecranon Plates, as part of<br>the 3.5 / 4.5 mm LCP System under the premarket notifica-<br>tion K082807 (Jan 13, 2009) and Synthes (USA) Small<br>Fragment Dynamic Compression Locking (DCL) System<br>under the premarket notification K000684 (Apr 28, 2000) |
| Device Description: | The aap LOQTEQ® Olecranon Plate consists of bone<br>plates and bone screws, to be implanted by a surgeon in<br>order to achieve an internal fixation of bone fragments typi-<br>cally after fractures. If the plates are used in conjunction<br>with locking screws, a so called internal fixator will be real-<br>ized (internal fixation). |
| | The aap LOQTEQ® Olecranon Plate System consists of:<br>• LOQTEQ® Olecranon Plate (left and right)<br>to be used with<br>• LOQTEQ® Cortical Screw 2.7, small head T8,<br>self-tapping<br>• Cortical Screw 2.5, small head T8, self-tapping<br>• LOQTEQ® Cortical Screw 3.5, T15, self-tapping<br>• Cortical Screw 3.5, self-tapping<br>• Set of Instruments aap LOQTEQ® Olecranon Plate |
| Material: | Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3) |
| Indications: | The aap LOQTEQ® Olecranon Plates are indicated for<br>fixation of fractures, osteotomies and nonunions of the<br>olecranon, particularly in osteopenic bone. |
| 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 has been provided with this sub-<br>mission. |
| Performance Data<br>(Non-Clinical and /<br>or Clinical): | Non-clinical tests have been performed and show<br>the substantial equivalence of the device. |

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Summary of Non-clinical tests:

Type of test:

Customized 4-point bending tests of bone plates, based on ASTM F382-99 (static and dynamic)

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 substantial equivalent, 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 has been provided with this submission.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

May 8, 2014

aap Implantate AG Dr. Christian Zietsch Manager Regulatory Affairs Lorenzweg 5 12099 Berlin Germany

Re: K140607

Trade/Device Name: aap LOQTEQ® Olecranon Plate 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: February 28, 2014 Received: March 10, 2014

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, 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

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#### Page 2 - Dr. Christian Zietsch

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 (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 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" (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/MedicalDeyices/Safety/ReportalProblem/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.hum.

Sincerely yours.

### Lori A. Wiggins

- 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): K140607

### Device Name: aap LOQTEQ® Olecranon Plate

#### Indications for Use:

The aap LOQTEQ® Olecranon Plates are indicated for fixation of fractures, osteotomies and nonunions of the olecranon, particularly in osteopenic bone.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

## Elizabeth=D&Frank -S

Division of Orthopedic Devices