AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM

K113601 · Aap Implantate AG · HRS · Nov 8, 2012 · Orthopedic

Device Facts

• Record ID: K113601
• Device Name: AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
• Applicant: Aap Implantate AG
• Product Code: HRS · Orthopedic
• Decision Date: Nov 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The aap LOQTEQ® Distal Medial Tibia Plate 3.5 System is intended for Fixation of complex intra- and extra-articular fractures of the distal tibia Osteotomies of the distal tibia

Device Story

System consists of titanium alloy bone plates and screws for internal fixation of distal tibia fractures and osteotomies. Plates are fixed to bone using cortical screws; locking screws create internal fixator construct. Used by orthopedic surgeons in clinical settings to stabilize bone fragments. Output is mechanical stabilization of bone; facilitates healing by maintaining alignment of fracture or osteotomy site.

Clinical Evidence

Bench testing only. Fatigue implant tests with progressive loadings were performed to represent worst-case clinical scenarios. Results confirmed mechanical performance and safety equivalent to the predicate device.

Technological Characteristics

Materials: Titanium alloy Ti6Al4V per ASTM F136 or ISO 5832-3. Components: Distal medial tibia plates (left/right), cortical screws (locking/non-locking, small head options), and associated surgical instruments. Principle: Internal fixation via bone plates and screws. Sterilization: Not specified.

Indications for Use

Indicated for fixation of complex intra- and extra-articular fractures of the distal tibia and osteotomies of the distal tibia in patients requiring bone fixation.

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

• 3.5 LCP® Distal Medial Tibia Plates, Synthes (USA) (K013248)

Submission Summary (Full Text)

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oap Implantate AG oap LOQTEQ® Distal Medial Tibla Plate 3.5 System

K 113601

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Summary of Safety and Effectiveness

Summary of Safety and Effectiveness

| Sponsor: | aap Implantate AG<br>Lorenzweg 5<br>D-12099 Berlin Germany |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Dipl.-Ing. Marc Seegers<br>Phone: [phone]<br>Fax: [phone] - 111 |
| Date: | November 28, 2011 |
| Trade Name: | aap LOQTEQ® Distal Medial Tibia Plate 3.5 System |
| Common Name: | Distal Medial Tibia Plate System |
| Classification: | |
| Classification Name and Reference: | 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories – Class II and<br>21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ HRS: Plate, Fixation, Bone<br>Orthopedics/87/ HWC: Screw, Fixation, Bone |
| Predicate device: | 3.5 LCP® Distal Medial Tibia Plates, Synthes (USA) premarket notification K013248 (DEC 19 2001) |
| Device Description: | Bone plates and screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries. Bone plates are fixed by the use of bone screws. Bone plates and bone screws are implants. If the plates are used in conjunction with locking screws, a so called internal fixator (internal fixation) will be realized. |
| | The LOQTEQ® Distal Medial Tibia Plate 3.5 System consists of: |
| | • LOQTEQ® Distal Medial Tibia Plate 3.5, left and right version |
| | • LOQTEQ® Cortical Screws 3.5, self-tapping (locking bone screw) |
| | • LOQTEQ® Cortical Screws 3.5 small head, self-tapping (locking bone screw) |
| | • Cortical Screws 3.5, self-tapping |
| | • Cortical Screws 3.5 small head, self tapping |
| | • Instruments, Distal Medial Tibia Plate 3.5 |
| Material: | Plates and Screws are made of titanium alloy Ti6Al4V according to ASTM F136 or ISO 5832-3. |

NOV 8 2012
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aop Implantate AG aap LOQTEQ® Distal Medial Tibia Plate 3.5 System

| Indication: | The aap LOQTEQ® Distal Medial Tibia Plates 3.5 System is intended for Fixation of complex intra- and extra-articular fractures of the distal tibia Osteotomies of the distal tibia |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence: | The Substantial Equivalence of the new device and the predicate<br>device is based on similar intended use, design, functionality, compo-<br>nents and materials in use.<br><br>Documentation including mechanical testing to show the substantial<br>equivalence and safety and effectiveness has been provided with this<br>submission. |
| Performance Data<br>(Non-Clinical and/or | Non-Clinical tests have been performed and show the effectiveness and<br>safety of the device. |

Clinical):

## Summary of Non-clinical tests:

Type of test:

Fatigue implant 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 & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Dated: November 8, 2012

aap Implante AG % Mr. Marc Seegers Director QA/RA Lorenzweig 5 D-12099 Berlin Germany

Re: K113601

Trade/Device Name: LOQTEQ® Distal Medial Tibia Plate 3.5 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: October 19, 2012 Received: October 22, 2012

Dear Mr. Seegers:

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 - Mr. Marc Seegers

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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/Industrv/default.htm.

Sincerely yours.

# Mark N. Melkerson

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): K113601

## Device Name: LOQTEQ® Distal Medial Tibia Plate 3.5 System

## Indications for Use:

The aap LOQTEQ® Distal Medial Tibia Plate 3.5 System is intended for

- Fixation of complex intra- and extra- articular fractures of the distal tibia ●
- Osteotomies of the distal tibia .

Prescription Use × (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) | |
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(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113601