Profile: Synthes GmbH develops, produces and markets instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the skeleton & its soft tissues. Trauma implants and instruments are used for the surgical treatment of fractures, deformities & tumor diseases of long bones (arms & legs), the shoulder, the hand, the foot & the pelvis. The portfolio contains plates, screws, cannulated screws, intramedullary nails, a comprehensive range of external fixators, products for the hip & condyles and a wide selection of instruments. The dynamic hip system (DHS) is the appropriate solution for proximal femoral fractures. It is modular and consists of DHS blade or DHS screw, LCP plates or standard plates & locking trochanter stabilizing plate. Our spine portfolio covers products for the treatment of degenerative instabilities, fractures, tumors, and deformities, offering a full range of solutions for the cervical, thoracic & lumbar spine.

FDA Registration Number: 8030965
US Agent: Karen Parker / Synthes Gmbh / Synthes Produktions Gmbh
Phone: +1-(610)-719-6567  E-Mail:

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• 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.

• AC-Powered Surgical Instrument Motor (FDA Code: GEY / 878.4820)

• Arthroscopic Accessories (FDA Code: NBH / 888.1100) An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

• Awl (FDA Code: HWJ / 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.

• Bender (FDA Code: HXW / 888.4540)

• Bending/Contouring Instrument (FDA Code: HXP / 888.4540)

• Bone Clamp (FDA Code: HXD / 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.

• 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 Fixation Staple (FDA Code: JDR / 888.3030)

• Bone Hooks (FDA Code: KIK / 878.4800)

• Bone Mallets (FDA Code: HXL / 878.4800)

• Bone Rasps (FDA Code: HTR / 878.4800)

• Bone Screw Starter (FDA Code: HWD / 888.4540)

• Bone Taps (FDA Code: HWX / 888.4540)

• Bone Trephine (FDA Code: HWK / 888.4540)

• Burr Hole Cover (FDA Code: GXR / 882.5250) A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.

• Calcium Compound Bone Void Filler (FDA Code: MQV / 888.3045) A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

• Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP / 888.3080)

• Compression Instrument (FDA Code: HWN / 888.4540)

• Countersink (FDA Code: HWW / 888.4540)

• Cranioplasty Plate Fastener (FDA Code: HBW / 882.5360) A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.

• Curettes (FDA Code: HTF / 878.4800)

• 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)

• Electric ENT Surgical Drill (FDA Code: ERL / 874.4250) An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

• ENT Trocar (FDA Code: KTE / 874.4420)

• Flexible Depth Gauge (FDA Code: HTJ / 888.4300)

• Forceps (FDA Code: HTD / 878.4800)

• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820)

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)

• General & Plastic Surgery Surgical Burr (FDA Code: GFF / 878.4820)

• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800)

• General & Plastic Surgery Surgical Gouge (FDA Code: GDH / 878.4800)

• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800)

• General & Plastic Surgery Surgical Spatula (FDA Code: GAF / 878.4800)

• Guiding Probes

• Human Bone Rasps (FDA Code: HTR / 878.4800)

• Impactor (FDA Code: HWA / 888.4540)

• Instrument Surgical Guide (FDA Code: FZX / 878.4800)

• Intramedullary Fixation Rod and Accessories (FDA Code: HSB / 888.3020) An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

• Invasive Traction Component (FDA Code: JEC / 888.3040)

• Laparoscopic Probes

• Laser Power Probe

• Lumbar Intervertebral Fusion Device with Bone Graft (FDA Code: MAX / 888.3080)

• Manual Surgical Chisel (FDA Code: FZO / 878.4800)

• Medical Probes (FDA Code: HXB / 888.4540)

• Medical Rasps (FDA Code: HTR / 878.4800)

• Metal Laminoplasty Plate Spine Orthosis (FDA Code: NQW / 888.3050) A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.