AAP CANNULATED SCREW 2.0

K130590 · Aap Implantate AG · HWC · Apr 22, 2013 · Orthopedic

Device Facts

• Record ID: K130590
• Device Name: AAP CANNULATED SCREW 2.0
• Applicant: Aap Implantate AG
• Product Code: HWC · Orthopedic
• Decision Date: Apr 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The aap Cannulated Screw 2.0 is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

Device Story

The aap Cannulated Screw 2.0 is a metallic bone fixation system consisting of cannulated screws (long and short thread) and washers. Used by orthopedic surgeons for fracture fixation of small and long bones and the pelvis. The device is implanted during surgery to stabilize bone fragments. It is not intended for spinal applications. The system includes a set of dedicated instruments for implantation.

Clinical Evidence

Bench testing only. Mechanical testing of screws performed according to ASTM F543-07. Results confirmed the device fulfills relevant requirements and pre-defined acceptance criteria.

Technological Characteristics

Implants manufactured from Ti6Al4V (ASTM F136 or ISO 5832-3) or stainless steel (ASTM F138 or ISO 5832-1). Cannulated design with 2.0 mm diameter. Includes washers and instrument set. No software or electronic components.

Indications for Use

Indicated for fracture fixation of small and long bones and of the pelvis. Not intended for spinal use.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Asnis™ Micro Cannulated Screw System (K071092)

Submission Summary (Full Text)

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aap Implantate AG aap Cannulated Screw 2.0

## K130590 page 1 of 2

# SO (K) Summary of Safety and Effectiveness

APR 2 2 2013

| Sponsor: | aap Implantate AG<br>Lorenzweg 5<br>D-12099 Berlin Germany |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Dr. Christian Zietsch<br>Phone: [phone]<br>Fax: [phone] - 111 |
| Date | February/28/ 2013 |
| Trade Name: | aap Cannulated Screw 2.0 |
| Common Name: | Cannulated Screw 2.0 |
| 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 fixa-<br>tion fastener - Class II |
| Device Product Code and<br>Panel Code: | Orthopedics/87/ HWC: Screw, Fixation, Bone<br>Orthopedics/87/ HTN: Washer, Bolt Nut |
| Predicate device: | Asnis™ Micro Cannulated Screw System<br>from Stryker (former Howmedica) under the premarket noti-<br>fication K071092 (May 11, 2007) |
| Device Description: | Cannulated Screws are used for fixation of bone frag-<br>ments, i.e., for treatment of bone fractures and other bone<br>injuries. Cannulated Screws with a diameter of 2.0 mm are<br>manly in use for foot and hand surgery.<br><br>The aap Cannulated Screw 2.0 consists of:<br>• Cannulated Screw 2.0, Long thread<br>• Cannulated Screw 2.0, Short thread<br>• Washer<br>• Set of Instruments Cannulated Screws |
| Material: | Implants made of Ti6Al4V (ASTM F136 or ISO 5832-3) or<br>Implants made of stainless steel (ASTM F138<br>or ISO 5832-1) |
| Indications: | The aap Cannulated Screw 2.0 is intended for fracture fixa-<br>tion of small and long bones and of the pelvis. The system<br>is not intended for spinal use. |
| 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.<br><br>Documentation including mechanical testing to show the<br>substantial equivalence and safety and effectiveness has<br>been provided with this submission. |

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oop Implantate AG aap Cannulated Screw 2.0

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: Mechanical tests of Screws acc. to ASTM F543-07

Assessment of test results: The 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.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

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

April 22, 2013

aap Implantate AG % Dr. Christian Zietsch Manager RA Lorenzweg 5 D-12099 Berlin Germany

Re: K130590

Trade/Device Name: aap Cannulated Screw 2.0 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: February 28, 2013 Received: March 14, 2013

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 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

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#### Page 2 - Dr. Christian Zietsch

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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/3/Picture/6 description: The image shows the name "Erin DKeith" in a stylized font. The letters "E", "r", "i", and "n" are in a simple, bold font. The letters "D", "K", "e", "i", "t", and "h" are in a more complex font with lines and shapes.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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aap Implantate AG aap Cannulated Screw 2.0

### Indications for Use Statement

510(k) Number (if known): K130590

#### Device Name: aap Cannulated Screw 2.0

### Indications for Use:

The aap Cannulated Screw 2.0 is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

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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## Elizabeth @ Frank -S

Division of Orthopedic Devices