Profile: Pioneer Surgical Technology deals with the design and manufacture of spinal & orthopedic implants & instruments. Our Quantum® spinal rod system comes with polyaxial & fixed pedicle screws, straight & bent rods, and crosslinks. It allows for distraction, compression, and high grade spondy reduction. The Quantum® MIS rodding system is designed for one or two level fixation. It uses polyaxial screws, locking caps and titanium alloy rods. It is a non-invasive instrumentation which helps to control compression, distraction, and reduction.

The company was founded in 1992, has revenues of USD 25-50 Million, has ~140 employees and is ISO 9001, CE certified.

FDA Registration Number: 1833824

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• Anterior Cervical Plating System

• 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)

• Bone Fixation Plate (FDA Code: HRS / 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 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 Rasps (FDA Code: HTR / 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 Taps (FDA Code: HWX / 888.4540)

• 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)

• 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.

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• ENT Nerve Stimulator (FDA Code: ETN / 874.1820) A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

• Fiberoptic Retractor (FDA Code: FDG / 876.4530) A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.

• Fixation Cerclage (FDA Code: JDQ / 888.3010) A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

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

• Fork (FDA Code: HXE / 888.4540)

• General & Plastic Surgery Ventricular Catheter (FDA Code: GBS / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

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

• 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.

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

• Manual Osteotome (FDA Code: GFI / 878.4800)

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

• Medical Probes (FDA Code: HXB / 888.4540)

• Medical Rasps (FDA Code: HTR / 878.4800)

• Modular Sternal Cable System

• Multiple Component Fixation Appliance (FDA Code: KTT / 888.3030)

• Needle Electrode (FDA Code: GXZ / 882.1350) A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

• Nut Bolt Washer (FDA Code: HTN / 888.3030)

• Probes (FDA Code: HXB / 888.4540)

• Probes (FDA Code: HXB / 888.4540)

• Prosthesis Driver (FDA Code: HWR / 888.4540)

• Screwdriver (FDA Code: HXX / 888.4540)

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

• Spinal Cables

• Spinal Fixation Device Implant (FDA Code: JDN / 888.3060) A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back," scoliosis (lateral curvature of the spine), or other conditions.

• Spinal Interlaminal Fixation Appliance (FDA Code: KWP / 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.

• Spinal Intervertebral Body Fixation Appliance (FDA Code: KWQ / 888.3060)

• Spinal Pedicle Fixation Orthosis (FDA Code: MNI / 888.3070) Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.

• Spinal Pedicle Fixation Orthosis For Degenerative Disc Disease (FDA Code: NKB / 888.3070)

• Spinal Rod Systems

• Spinal Vertebral Body Replacement Device (FDA Code: MQP / 888.3060)

• Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH / 888.3070)

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)