LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING

K121494 · Aap Implantate AG · HRS · Nov 19, 2012 · Orthopedic

Device Facts

• Record ID: K121494
• Device Name: LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING
• Applicant: Aap Implantate AG
• Product Code: HRS · Orthopedic
• Decision Date: Nov 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The aap LOQTEQ® Distal Lateral Femur Plate 4.5 System include plates for the left and right human femur. The plates accept 4.5 mm locking screws, 4.5 mm cortical screws and 4.5 mm periprosthetic screws. They are intended for: Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures in normal or osteopenic bone; non-unions and malunions ; and osteotomies of the femur

Device Story

System consists of titanium alloy bone plates and screws (locking, cortical, periprosthetic) used for internal fixation of distal femur fractures. Plates are applied to bone fragments and secured with screws to provide structural support (buttressing) during healing. Used by orthopedic surgeons in clinical/surgical settings. Device stabilizes fractures, non-unions, or osteotomy sites, facilitating bone alignment and healing. Mechanical performance validated via fatigue testing and ASTM F543-07 screw testing.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing, including fatigue implant tests with progressive loadings representing worst-case scenarios and mechanical testing of periprosthetic screws per ASTM F543-07.

Technological Characteristics

Materials: Ti6Al4V (ASTM F136 or ISO 5832-3). Components: Distal lateral femur plates (left/right), 4.5mm locking cortical screws, 4.5mm periprosthetic screws, and 4.5mm cortical screws. Principle: Internal fixation/buttressing via locking screw technology. Mechanical testing performed per ASTM F543-07.

Indications for Use

Indicated for patients with multifragmentary distal femur fractures, including supracondylar, intra-articular, extra-articular condylar, and periprosthetic fractures; fractures in normal or osteopenic bone; non-unions; malunions; and femoral osteotomies.

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

• LCP® Distal Femur Plates of Synthes (USA) (K062564)

Submission Summary (Full Text)

{0}------------------------------------------------

121494

fe 1/2

aap Implantate AG ααρ LOQTEQ® Distal Lateral Femur Plate 4.5 System

# Summary of Safety and Effectiveness

| Sponsor: | aap Implantate AG<br>Lorenzweg 5<br>D-12099 Berlin Germany | NOV 1 9 2012 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Company Contact: | Dipl.-Ing. Marc Seegers<br>Phone:[phone]<br>Fax: [phone] | |
| Date | May 9, 2012 | |
| Trade Name: | aap LOQTEQ® Distal Lateral Femur Plate 4.5 System | |
| Common Name: | Distal Lateral Femur Plate | |
| 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 fixation fas-<br>tener - Class II | |
| Device Product Code and<br>Panel Code: | Orthopedics/87/ HRS: Plate, Fixation, Bone<br>Orthopedics/87/ HWC: Screw, Fixation, Bone | |
| Predicate device: | LCP® Distal Femur Plates of Synthes (USA) with premarket noti-<br>fication no. K062564 (OCT 19, 2006). | |
| Device Description: | Bone plates and screws are used for fixation of bone fragments,<br>i.e., for treatment of bone fractures and other bone injuries.<br>Bone plates are fixed by the use of bone screws. Bone plates<br>and bone screws are implants. If the plates are used in conjunc-<br>tion with locking screws, a so called internal fixator will be real-<br>ized (internal fixation).<br>The LOQTEQ® Distal Lateral Femur Plate 4.5 System consists of:<br>LOQTEQ® Distal Lateral Femur Plate 4.5 (left and right version) LOQTEQ® Cortical Screw 4.5, T25, self-tapping (locking bone screw) LOQTEQ® Periprosthetic Screw. 4.5, T25, self-tapping (locking bone screw) Cortical bone screws 4.5 mm, self tapping Set of Instruments, Distal Lateral Femur Plate 4.5 | |
| Material: | Plates and Screws are made of Ti6Al4V (ASTM F136<br>or ISO 5832-3) | |

Page 1 of 2

{1}------------------------------------------------

K121494

Page 2/2

aap Implantate AG

aop LOQTEQ® Distal Lateral Femur Plate 4.5 Syst

Indications: Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures; fractures in normal or osteopenic bone; non-unions and malunions ; and osteotomies of the femur 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:

Fatigue implant tests with progressive loadings, representing worst case scenario with respect to clinical use. Mechanical tests of Periprosthetic Screws acc. to ASTM F543-07

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.

The Periprosthetic Screws fulfil the relevant requirements of ASTM F543-07 and 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.

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

### Letter Dated: November 19, 2012

aap Implantate AG % Mr. Marc Seegers Regulatory Affairs Specialist Lorenzweg 5 D-12099 Berlin,Germany

Re: K121494

Trade/Device Name: app LOQTEO® Distal Lateral Femur Plate 4.5 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 26, 2012 Received: October 31, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{3}------------------------------------------------

Page 2 - Mr. Marc Seegers

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/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. Erin I. Keith Mark N. Melkerson Director

Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Traditional Premarket Notification oop Implantate AG oop LOQTEQ® Distal Lateral Femur Plate 4.5 System Section 4 Indications for Use Statement

## 4. Indications for Use Statement

12/444 510(k) Number (if known):

## Device Name: LOQTEQ® Distal Lateral Femur Plate 4.5 System

## Indications for Use:

The aap LOQTEQ® Distal Lateral Femur Plate 4.5 System include plates for the left and right human femur. The plates accept 4.5 mm locking screws, 4.5 mm cortical screws and 4.5 mm periprosthetic screws. They are intended for:

Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures in normal or osteopenic bone; non-unions and malunions ; and osteotomies of the femur

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)

Younle

(Division Sign-Off).
Division of Orthopedic Devices
510(k) Number K121494

Page 1 of