The aap AcroPlate with 3 holes is intended for use for healing an AC-joint injury of the Tossi III and Rockwood III-V. The ago AcroPlate with 4 holes is intended for use for healing an lateral fracture of the Clavicula.
Device Story
The aap AcroPlate is a metallic bone fixation device used for orthopedic stabilization. It consists of a plate available in 3-hole or 4-hole configurations. The device is manufactured from Titanium Alloy (Ti 6Al 4V E.L.I.) and 316L Stainless Steel. It is distributed non-sterile and requires steam sterilization by the end-user in a clinical setting according to AAMI guidelines. The device is implanted by a surgeon to provide mechanical fixation for clavicular fractures or AC-joint dislocations, facilitating bone healing.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Materials: Titanium Alloy (ASTM F136) and 316L Stainless Steel (ASTM F138). Form factor: 3-hole or 4-hole bone plate. Sterilization: Steam sterilization (AAMI/ANSI/ISO 11737).
Indications for Use
Indicated for patients with acromioclavicular dislocations (Tossi III and Rockwood III-V) or extremely lateral fractures of the clavicle.
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.
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030909
## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitters Name: | aap Implantate AG<br>Lorenzweg 5<br>12099 Berlin<br>Germany<br>Phone: +49 30 750 19 0<br>Fax: +49 30 750 19 111 | APR 1 0 2003 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Name: | Dipl.-Ing. Christian Abel, Director Quality Management | |
| Name of Device: | aap AcroPlate | |
| Classification Name: | Single/multiple component metallic bone fixation appliances and<br>accessories | |
| Common/Usual Name: | aap AcroPlate | |
| Proprietary Name: | aap AcroPlate | |
| Classification: | Class II, Single/multiple component metallic bone fixation<br>appliances and accessories,<br>CFR Chapter I, Title 21 § 888.3030, # 87 H RS # | |
Performance Standards: Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable harmonised standards ISO 9001 / EN 46001.
Material Composition: The agp AcroPlate is manufactured of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136), and 316L Stainless Steel (ASTM F 138)
Intended Use: The aap AcroPlate with 3 holes is intended for use for healing an AC-joint injury of the Tossi III and Rockwood III-V.
The ago AcroPlate with 4 holes is intended for use for healing an lateral fracture of the Clavicula.
Device Description: The qqp AcroPlate is manufactured of Titanium Alloy (Ti Al6 V4 E.L.), and 316 L Stainless Steel. The agp AcroPlate is available with 3 or 4 holes.
Predicate Devices for Substantial Equivalence: K915315 aap Bone Plate
Comparision of Technological Characteristics: The agp AcroPlate is substantially equivalent to the predicate devices with respect to physical/technical and material characteristics.
Sterilisation Information: The devices are distributed in non sterile, recommendations for sterilization are contained in package insert. Note: These devices are sterilised by end users utilizing the approved/outlines found in the AAMI Guideline "Good Hospital Practice: Steam Sterilisation and Sterility Assurance" and in ANSI/AAMI/ISO 11737 guidelines to achieve the acceptable Sterility Assurance Level (SAL).
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird with three wing-like shapes above a curved base. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2003
Dipl .- Ing. Christian Abel Quality Management, Research and Development aap Implantate AG Lorenzweg 5 12099 Berlin Germany
Re: K030909 Trade/Device Name: aap AcroPlate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: March 19, 2003 Received: March 24, 2003
Dear Mr. Abel:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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## Page 2 - Dipl .- Ing. Christian Abel
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark N.Milkinson
MNM
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use Statement
Page 1 of 1
510(k) Number (if known): KC 30909
Device Name: aap AcroPlate
Indications for Use:
The aap AcroPlate is intended for use on:
- Acromioclavicular dislocations Type Tossi III and Type Rockwood III-V ●
- Extremely lateral fractures of the clavicula .
en Mark N. Millken
Division Sign-Off) Di ision of General, Restorative and Neurological Devices
K030909 510(k) Number _
