BNF

{0}------------------------------------------------ ## AUG 2 6 2002 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Submitters Name: aap Implantate AG Lorenzweg 5 12099 Berlin Germany Ph.: +49 30 750 19 0 Fax: +49 30 750 19 111 Biorigid Nail Femur (BNF) Intramedullary Fixation Rod Biorigid Femoral Nail System aap Biorigid Nail Femur (BNF) cd1782 page 1 of 2 Contact Name: Name of Device: Classification Name: Common/Usual Name: Proprietary Name: Classification: 전 - - - --------------------------------------------------------------------------------------------------------------------------------------------------------------------- CFR Chapter I, Title 21 § 888.3020, # 87 J DS #, # 87 H SB #, # 87 H TN # Class II, Intramedullary Fixation Rod, Dipl .- Ing. Christian Abel, Director Quality Management Performance Standards: Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable harmonised standards ISO 9001 / EN 46001. Material Composition: aap Biorigid Nail Femur components are manufactured of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136) Intended Use: aap Biorigid Nail Femur (BNF) is intended to use in fractures of the femoral bone. The indications are: | • Types of Fractures: | Simple closed fractures<br>Comminuted fractures<br>Open fractures of first, second or third degree<br>Crush fractures | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | • Antegrade Indications: | Femur shaft fractures<br>Distal femur shaft fractures<br>Pathological fractures, e.g. tumor osteolysis<br>Periprosthetic femur fracture in the middle to third part<br>with knee replacement in situ | | • Retrograde Indications: | Supracondylary fractures<br>Simultaneous nailing of femur and tibia<br>Distal femur fracture with osteosynthesis or hip<br>prosthesis in situ<br>Periprosthetic femur fracture at knee arthroplasty | | • Borderline Indications: | Percondylar femur fracture<br>Pseudarthrosis (only reamed method)<br>Osteoporosis | {1}------------------------------------------------ Device Description: 용품 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Jofa Kod1782 Intramedullary rods are used for the stabilisation of fractures or correction of deformity of ong bones with or without interlocking screws. The connection between the nail and the interlocking screw is realised with central holes or grooves. Reamed and unreamed intramedullary nailing and for the femoral bone the antegrade and retrograde entrance are standard methods today. agp Bioriqid Nail Femur (BNF) is the consistent development of the Biorigid Nail Tibia for the femoral bone. The BNF is a full material nail. The interlocking of the nail happens with solid Ø 5.3 mm screws through central holes and grooves. The central holes on the nail protect against rotational forces. The grooves are designed for interlocking possibility over the whole length of the nail and a defined reduction of the rigidity because of the full material nail. The BNF permits the execution of different implantation techniques and interlocking with only one nail. Therefore it meets the different injury manners and necessity for individual solutions. aap Biorigid Nail Femur (BNF) incorporates - Nail in different diameters . - Interlocking screws in different lenghts ● - Interlocking nut ● - Protection cap in different lengths ● - CondyLock ● - Accessories, like targeting devices etc. ● Predicate Devices for Substantial Equivalence: aap Implantate AG 's Biorigid Nail Femur (BNF) is similar in size, material and intended use to the Howmedica Osteonics Corp. T2 Femoral Nail System (K010801 / K011622 / K014220), Synthes Ti Distal Femoral Nail (K970733), Synthes Proximal Femoral Nail (K970097), Synthes Titanium Unreamed Femoral Nail (K923597), Smith & Nephew Titanium Nail System (K981529), Smith & Nephew Intramedullary Nail System (K983942), DePuy ACE AIM Titanium Supracondylar Nail (K974781), Biomet Titanium Intramedullary Nails (K982953), Biomet Titanium Retrograde Femoral Nail (K013923) Comparision of Technological Characteristics: aap BNF is substantially equivalent to the predicate devices with respect to physical/technical and material characteristics. Sterilisation Information: The devices are distributed in non sterile condition. The instruments and implants provided in non-sterile condition must be decontaminated. cleaned and sterilised prior to each surgery. All packaqing materials must be removed. Recommendations for sterilisation are contained in the package insert. Note: These devices are sterilised by end users utilizing the approved/outlined quidelines 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). {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles or faces stacked on top of each other. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 **AUG 26 2002** AAP Implantate AG Dipl.-Ing. Christian Abel Director Quality Management Lorenzweg 5 12099 Berlin Germany Re: K021782 Trade/Device Name: aap Biorigid Nail Femur (BNF) Regulation Number: 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: JDS Dated: May 14, 2002 Received: May 30, 2002 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 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. {3}------------------------------------------------ Page 2 - Mr. Christian Abel 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours. 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 {4}------------------------------------------------ Page 1 of 1 510(k) Number (if known):_K021782 Device Name: BNF Indications For Use: Types of Fractures: Simple Closed Fractures Comminuted Fractures Open Fractures of First, Second or Third Degree Crush Fractures Antegrade Indications: Femur Shaft Fractures Distal Femur Shaft Fractures Pathological Fractures (e.g. Tumor Osteolysis) Periprosthetic Femur Fracture in the Middle of Third Part with Knee Replacement in Situ Retrograde Indications: Supracondylary Fractures Simultaneous Nailing of Femur and Tibia Distal Femur Fracture with Osteosynthesis or Hip Prosthesis in Situ Periprosthetic Femur Fracture at Knee Arthosplasty Borderline Indications: Percondylar Femur Fracture, (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |-----------------------------------------------------------|---------| | Division of General, Restorative and Neurological Devices | | | 510(k) Number | K021782 | | Prescription Use | OR | Over-The-Counter Use | |------------------|----|----------------------| |------------------|----|----------------------| (Per 21 CFR 801.109) Over-The-Counter Use*_*_ (Optional Formal 1-2-1