aap Biomaterials GmbH

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Contact: Volker Stirnal
Web: http://www.aap.de
E-Mail:
Address: Lagerstr. 11-15, Dieburg D-64807, Germany
Phone: +49-(6071)-929-0 | Fax: +49-(6071)-929-100 | Map/Directions >>
 
 

Profile: aap Biomaterials GmbH specializes in developing, manufacturing and marketing implants & biomaterials for trauma & joint reconstruction. Our product portfolio includes implants for fracture healing and joint replacement, bone cements, bone graft substitutes & antibiotical carriers. We supply a wide range of plates (T, L, quarter tubular, reconstruction plates for miniature, small & large bone fragments) along with matching corticalis and spongiosa screws. Our Biorigid Nail™ tibia and Biorigid Nail™ femur are used in modern trauma surgery. We have developed a complete system based on the principle of interlocking grooves for use in the treatment of tubular bone fractures of the upper and lower thigh. The angle-stable plates for treating fractures of the upper & lower arm feature a spherical thread on the screw head and in the hole plate, ensuring that the plate stays at a stable angle. Easymix® is an effective cement mixing system that is easy to use. It consists of an Easymix® vacuum pump and Easymix® cement gun & various cartridge sets. The Easymix® pump works evenly and reliably at supply pressures in the range of 5 to 10 bar. It has a return valve, so it does not have to be operated continuously, but only for 20 seconds to evacuate the mixing system. The active carbon filter, in combination with a sterile filter, has a particularly high capacity for binding monomer fumes.

FDA Registration Number: 9615014
US Agent: Christine L. Brauer / Brauer Device Consultants, Llc
Phone: +1-(301)-545-1993  Fax: +1-(301)-545-1992  E-Mail:

29 Products/Services (Click for related suppliers)  
• AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE / 878.4820)
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
• Bone Cement (FDA Code: LOD / 888.3027)
Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
• Bone Fixation Nail (FDA Code: JDS / 888.3030)
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.
• Bone Fixation Plate (FDA Code: HRS / 888.3030)
• Bone Fixation Screw (FDA Code: HWC / 888.3040)
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.
• Bone Taps (FDA Code: HWX / 888.4540)
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
• Cement Dispenser (FDA Code: KIH / 888.4200)
A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.
• Cement Mixing Equipment (FDA Code: JDZ / 888.4210)
A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (888.3027).
• Cement Monomer Vapor Evacuator (FDA Code: JDY / 888.4220)
A cement monomer vapor evacuator is a device intended for use during surgery to contain or remove undesirable fumes, such as monomer vapor from bone cement (888.3027).
• Compression Instrument (FDA Code: HWN / 888.4540)
• Countersink (FDA Code: HWW / 888.4540)
• Depth Gauge (FDA Code: HTJ / 888.4300)
A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.
• Drill Bit (FDA Code: HTW / 888.4540)
• Flexible Depth Gauge (FDA Code: HTJ / 888.4300)
• Forceps (FDA Code: HTD / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
• Impactor (FDA Code: HWA / 888.4540)
• Instrument Surgical Guide (FDA Code: FZX / 878.4800)
• Manual Surgical Chisel (FDA Code: FZO / 878.4800)
• Multiple Component Fixation Appliance (FDA Code: KTT / 888.3030)
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)
• Pin Surgical Driver (FDA Code: GFC / 878.4820)
• Reamer (FDA Code: HTO / 888.4540)
• Screwdriver (FDA Code: HXX / 888.4540)
• Small Depth Gauge (FDA Code: HTJ / 888.4300)
• Smooth Fixation Pin (FDA Code: HTY / 888.3040)
• Surgical Hammer (FDA Code: FZY / 878.4800)
• Surgical Instrument Tray (FDA Code: FSM / 878.4800)
• Vertebroplasty Bone Cement (FDA Code: NDN / 888.3027)
• Wrench (FDA Code: HXC / 888.4540)

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