aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium

K150974 · Aap Implantate AG · HWC · Apr 29, 2015 · Orthopedic

Device Facts

• Record ID: K150974
• Device Name: aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium
• Applicant: Aap Implantate AG
• Product Code: HWC · Orthopedic
• Decision Date: Apr 29, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metatsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management). All aap bone screws are for single use only and are not intended for any spinal fixation procedures.

Device Story

aap Cortical Screws 1.5 are metallic bone fixation fasteners used by surgeons to stabilize bone fragments following fractures or osteotomies. The screws are implanted during orthopedic procedures, either independently as lag screws or in conjunction with bone plates. By providing mechanical fixation, the screws hold bone fragments in place to facilitate healing. The device is intended for single use only.

Clinical Evidence

No clinical data; substantial equivalence is supported by engineering rationale and bench testing.

Technological Characteristics

Materials: Stainless Steel (ASTM F138/ISO 5832-1) or Ti6Al4V (ASTM F136/ISO 5832-3). Design: Self-tapping cortical bone screws. Form factor: 1.5mm diameter. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring internal fixation of bone fractures or osteotomies in the clavicle, scapula, pelvis, long bones, and small bones (metacarpals, metatarsals, phalanges). Contraindicated for spinal fixation procedures.

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

• aap Screw Implants (K072411)

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

April 29, 2015

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

Re: K150974

Trade/Device Name: aap Cortical Screws 1.5, Self-tapping, aap Cortical Screws 1.5, Selftapping, Titanium Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 10, 2015 Received: April 13, 2015

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 (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

## Mark N. Melkerson -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K150974

Device Name aap Cortical Screws 1.5, self-tapping aap Cortical Screws 1.5, self-tapping, titanium

Indications for Use (Describe)

The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metatsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management).

All aap bone screws are for single use only and are not intended for any spinal fixation procedures.

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> <span style="padding-right: 5px;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="padding-right: 5px;"></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
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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 | April/10/ 2015 |
| Trade Name: | aap Cortical Screws 1.5, self-tapping<br>aap Cortical Screws 1.5, self-tapping, titanium |
| Common Name: | Screw, fixation, bone |
| Classification Name and<br>Reference: | 21 CFR 888.3040 Smooth or threaded metallic<br>bone fixation fastener - Class II |
| Device Product Code and<br>Panel Code: | Orthopedics/87/HWC |
| Predicate device: | The aap Cortical Screw 1.5, self-tapping is substantially<br>equivalent to aap Screw Implants under the premarket noti-<br>fication K072411 (Mar 20, 2008). |
| Purpose of Submission | This special 510(k) premarket notification is submitted to<br>obtain clearance for the aap Cortical Screws 1.5, self-<br>tapping (titanium) |
| Device Description: | The aap Cortical Screws 1.5, self-tapping are bone<br>screws, to be implanted by a surgeon in order to achieve<br>an internal fixation of bone fragments typically after frac-<br>tures or osteotomies. The screws can be used along with<br>the aap bone plate as well as lag screws, to hold together<br>fragments of bone. The devices are made of Implant Stain-<br>less Steel or Titanium alloy. |
| | Variations of the aap Cortical Screw 1.5, self-tapping |
| | • Cortical Screw 1.5, self-tapping<br>• Cortical Screw 1.5, self-tapping, Titanium |
| Material: | Implants are made of Stainless Steel (ASTM F138 or ISO<br>5832-1) or Ti6Al4V (ASTM F136 or ISO 5832-3) |

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| Indications: | The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management). |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | All aap bone screws are for single use only and are not intended for any spinal fixation procedures. |
| Substantial Equivalence Summary | The Substantial Equivalence of the new device and the predicate device is based on similar intended use, design, functionality, components, technological characteristics and materials in use. |
| | Documentation to show the substantial equivalence has been provided with this submission. |
| | Engineering rationale have been prepared and show the substantial equivalence of the device. |
| | <u>Summary of Engineering rationale:</u> |
| | Any differences between the subject devices and the predicates are considered minor and do not raise questions concerning safety and effectiveness. |