LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG

K121495 · Aap Implantate AG · HRS · Dec 7, 2012 · Orthopedic

Device Facts

• Record ID: K121495
• Device Name: LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG
• Applicant: Aap Implantate AG
• Product Code: HRS · Orthopedic
• Decision Date: Dec 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The aap LOQTEQ® Proximal Humerus Plate 3.5 System includes LOQTEQ® Proximal Humerus Plate 3.5 short and LOQTEQ® Proximal Humerus Plate 3.5 long. The plates accept 3.5 mm cortical locking screws and 3.5 mm cortical screws as well as 3.8 mm cancellous locking screws. They are intended for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone

Device Story

LOQTEQ® Proximal Humerus Plate 3.5 System is a metallic bone fixation implant set. Components include titanium alloy plates (short/long) and various 3.5mm/3.8mm cortical and cancellous screws. Used by orthopedic surgeons in clinical settings for internal fixation of proximal humerus fractures, dislocations, osteotomies, and nonunions. Plates and screws provide mechanical stabilization of bone fragments to facilitate healing. System is particularly suited for osteopenic bone. Device is implanted surgically; provides structural support to bone during the healing process.

Clinical Evidence

Bench testing only. Fatigue implant tests with progressive loadings were performed to simulate worst-case clinical scenarios. No clinical data provided.

Technological Characteristics

Materials: Ti6Al4V (ASTM F136 or ISO 5832-3). Components: Bone plates and screws (cortical/cancellous). Principle: Internal fixation via locking/non-locking screw-plate construct. Form factor: Proximal humerus anatomical plates. Sterilization: Not specified.

Indications for Use

Indicated for patients with fractures, fracture dislocations, osteotomies, and nonunions of the proximal humerus, including those 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

• 3.5 mm LCP® Proximal Humerus Plate, Synthes (USA) (K011815, K041860)

Submission Summary (Full Text)

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K121495

## Summary of Safety and Effectiveness

DEC 0 7 2012 aap Implantate AG Sponsor: Lorenzweg 5 D-12099 Berlin. Germany Company Contact: Dipl .- Ing. Marc Seegers-Phone: [phone] [phone] - 111 Fax: Mav 9th 2012 Date Trade Name: aap LOQTEQ® Proximal Humerus Plate 3.5 System Common Name: Proximal Humerus Plate 3.5 System Classification Name and 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories - Class II and Reference: 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener -Class II Device Product Code and Orthopedics/87/ HRS: Plate, Fixation, Bone Orthopedics/87/ HWC: Screw, Fixation, Bone Panel Code: 3.5 mm LCP® Proximal Humerus Plate, Synthes (USA) Predicate device: with the premarket notifications K011815 (SEP 6, 2001) and K041860 (SEP 8, 2004) 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 with bone screws. Bone plates and bone screws are implants. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation). The LOQTEQ® Proximal Humerus Plate 3.5 System consists of: LOQTEQ® Proximal Humerus Plate 3.5, short . LOQTEQ® Proximal Humerus Plate 3.5, long ◆ . LOQTEQ® Cortical Screw 3.5, T15, self-tapping LOQTEQ® Cancellous Screw 3.8, T15 ● . Cortical Screw 3.5, self-tapping . Set of Instruments, Proximal Humerus Plate Material: Plates are made of Ti6Al4V (ASTM F136 or ISO 5832-3) Screws are made of Ti6Al4V (ASTM F136 or ISO 5832-3) fractures and fracture dislocations, osteotomies, and nonunions of the Indications: proximal humerus, particularly in osteopenic bone

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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 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.

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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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

### Public Health Service

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

Letter dated: December 7, 2012

Aap Implantate Ag % Mr. Marc Seegers Director QA/RA Lorenzweg 5 D-12099 Berlin Germany

Re: K121495

Trade/Device Name: LOOTEO® Proximal Humerus 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 25, 2012 Received: November 28, 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. Iisting 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

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### 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 (2.1 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.

Sincerelv vours.

# 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): K121495

# Device Name: LOQTEQ® Proximal Humerus Plate 3.5 System

### Indications for Use:

The aap LOQTEQ® Proximal Humerus Plate 3.5 System includes LOQTEQ® Proximal Humerus Plate 3.5 short and LOQTEQ® Proximal Humerus Plate 3.5 long. The plates accept 3.5 mm cortical locking screws and 3.5 mm cortical screws as well as 3.8 mm cancellous locking screws. They are intended for

fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone

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)

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Krishna Asundi for (Division Sign-Off) Division of Orthopedic Devices

2012.12.06 14:02:58 -05'00'