AAP LOQTEC CLAVICLE PLATES 2.7/3.5

K141823 · Aap Implantate AG · HRS · Aug 7, 2014 · Orthopedic

Device Facts

• Record ID: K141823
• Device Name: AAP LOQTEC CLAVICLE PLATES 2.7/3.5
• Applicant: Aap Implantate AG
• Product Code: HRS · Orthopedic
• Decision Date: Aug 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The aap LOQTEQ® Clavicle Shaft Plate and aap LOQTEQ® Superior Lateral Clavicle Plate are intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle. The aap LOQTEQ® AcroPlate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

Device Story

Metallic bone fixation system comprising plates and screws for internal fixation of clavicle fractures, malunions, non-unions, osteotomies, and acromioclavicular joint dislocations. Implanted by surgeons in clinical settings. System includes shaft plates, superior lateral plates, and AcroPlates used with self-tapping cortical screws. Locking screws enable internal fixator configuration. Provides mechanical stabilization of bone fragments to facilitate healing.

Clinical Evidence

Bench testing only. Customized 4-point-bending tests of bone plates performed based on ASTM F382-99. Results demonstrate mechanical performance meets pre-defined acceptance criteria and is substantially equivalent to predicate devices.

Technological Characteristics

Implants manufactured from Ti6Al4V (ASTM F136 or ISO 5832-3). System includes bone plates and self-tapping cortical screws (2.5mm/2.7mm/3.5mm). Mechanical fixation via locking/non-locking screw interface. Mechanical performance validated via 4-point bending tests per ASTM F382-99.

Indications for Use

Indicated for patients requiring fixation of clavicle fractures, malunions, non-unions, osteotomies, or acromioclavicular joint dislocations.

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 Clavicle Plate System (K073186)
• Synthes (USA) Clavicle Hook Plate (K061753)

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

August 7, 2014

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

Re: K141823

Trade/Device Name: aap LOOTEO® Clavicle Plates 2.7/3.5 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: June 25, 2014 Received: July 7, 2014

Dear Dr. Christian 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

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Page 2 – Dr. Christian Zietsch

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 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): K141823

#### Device Name: aap LOQTEQ® Clavicle Plates 2.7/3.5

#### Indications for Use:

The aap LOQTEQ® Clavicle Shaft Plate and aap LOQTEQ® Superior Lateral Clavicle Plate are intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle.

The aap LOQTEQ® AcroPlate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

× Prescription Use Prescription Use

VOR Over-The
(21 CFR

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)

# Elizabethīb%rank -S

Division of Orthopedic Devices

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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] |
| Date | June/20/ 2014 |
| Trade Name: | aap LOQTEQ® Clavicle Plates 2.7/3.5 |
| Common Name: | Clavicle Plates 2.7/3.5 |
| Classification Name and<br>Reference: | 21 CFR 888.3030 Single/multiple component metallic<br>bone fixation appliances and accessories – Class II |
| Device Product Code and<br>Panel Code: | Orthopedics/87/ HRS |
| Predicate device: | The aap LOQTEQ® Clavicle Plates 2.7/3.5 are substantial-<br>ly equivalent to Synthes (USA) 3.5 mm LCP Clavicle Plate<br>System under the premarket notification K073186 (Dec 17,<br>2007) and Synthes (USA) Clavicle Hook Plate under the<br>premarket notification K061753 (Aug 04, 2008). |
| Device Description: | The aap LOQTEQ® Clavicle Plates 2.7/3.5 consists of<br>bone plates and bone screws, to be implanted by a sur-<br>geon in order to achieve an internal fixation of bone frag-<br>ments typically after fractures, osteotomies. If the plates<br>are used in conjunction with locking screws, a so called in-<br>ternal fixator will be realized (internal fixation).<br>The aap LOQTEQ® Clavicle Plates 2.7/3.5 incorporate:<br>• LOQTEQ® Clavicle Shaft Plate (left and right)<br>• LOQTEQ® Superior Lateral Clavicle Plate (left and<br>right)<br>• LOQTEQ® AcroPlate 3.5 (left and right)<br>to be used with<br>• LOQTEQ® Cortical Screw 3.5, small head, T15,<br>self-tapping<br>• LOQTEQ® Cortical Screw 2.7, small head, T8, self-<br>tapping<br>• Cortical Screw 2.5, small head,T8, self-tapping<br>• Cortical Screw 3.5, small head, self tapping<br><br>• Set of Instruments aap LOQTEQ® Clavicle Plates<br>2.7/3.5 |

Material:

Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3)

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| Indications: | The aap LOQTEQ® Clavicle Shaft Plate and aap LOQTEQ® Superior Lateral Clavicle Plate are intended for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle. The aap LOQTEQ® AcroPlate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint. |
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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 has been provided with this submission. |
| Performance Data (Non-Clinical and / or Clinical): | Non-clinical tests have been performed and show the substantial equivalence of the device. |
| | Summary of Non-clinical tests: |
| | Type of test: Customized 4-point-bending tests of bone plates, based on ASTM F382-99 |
| | 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. |