Profile: Synthes, Inc. develops market instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the skeleton and its soft tissues. We develop & market instruments, implants & biomaterials for the surgical fixation, correction & regeneration of the human skeleton and its soft tissues. Our cranio-maxillofacial implants are used for the operative treatment of fractures of mandible, mid-face & skull. Our external fixator is used for external fracture stabilization at extremities with soft tissue injuries. The Trauma implants and instruments are used for the surgical treatment of fractures, deformities and tumour diseases of long bones (arms and legs), the shoulder, the hand, the foot and the pelvis and the portfolio contains plates, screws, cannulated screws, intramedullary nails, a comprehensive range. Our Bone void fillers are natural or synthetic materials which are placed into a bone defect during a surgical procedure to assist in bone regeneration. They fill a bone void or bridge a gap between bone segments and provide a three-dimensional scaffold for bone to grow on and also used for intended voids or gaps that are not intrinsic to the stability of the bone structure. They are used to augment internal or external fixation.

SWF:SYST (SEC Filings)

FDA Registration Number: 2939274

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• Adjustable Bone Holding Forceps

• Alterable Preformed Skull Bone Plate (FDA Code: GWO / 882.5320) A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

• Artificial Hydroxyapatite

• Artificial Hydroxyapatite Orbital Implant

• Bio-Eyes Hydroxyapatite Orbital Implant

• Bone Holding Forceps

• 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.

• 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).

• Cervical Disc Replacements

• Cervical Total Disc Replacement

• Clavicle Hook Plate

• Compression Hip Screw Systems

• Demineralized Bone Matrix

• Disc Replacements

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 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.

• Distal Humerus Plates

• Dynamic External Fixators

• Elbow External Fixators

• Enteral Irrigation Kit w/Piston Syringe

• Femoral IM Nails

• Femuroral Intramedullary Nails

• Fracture Hardware

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

• Hand External Fixators

• Hand Implants Fracture Hardware

• Human Demineralized Bone Matrix

• Hybrid External Fixators

• Hydroxyapatite

• Hydroxyapatite Cement

• Hydroxyapatite Coated Implants

• Hydroxyapatite Orbital Implants

• Large External Fixators

• Lumbar Total Disc Replacement

• Medial Distal Tibia Plates

• Methyl Methacrylate for Cranioplasty (FDA Code: GXP / 882.5300) Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

• Modular Sternal Cable System

• Orthopedic Fracture Hardware

• Osteoinductive Demineralized Bone Matrix

• Pediatric Hip Plate

• Pin & Wire Cutters

• Piston Syringe (FDA Code: FMF / 880.5860) A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

• Polymeric Surgical Mesh (FDA Code: FTL / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

• Porous hydroxyapatite orbital implants

• Proximal Tibia Plate

• Resorbable Plating Systems

• Self Centering Bone Holding Forceps

• Static External Fixators

• Surgical Bone Holding forceps

• Surgical Mesh (FDA Code: FTM / 878.3300)