Tornier Inc.

Click Here To EMAIL INQUIRY
Web: http://www.tornier-us.com
E-Mail:
Address: 100 Cummings Center, Suite 444c, Beverly, Massachusetts 01915, USA
Phone: +1-(978)-232-9997, 800-611-2992 | Map/Directions >>

Profile: Tornier Inc. specializes in orthopedic industry. We offer a broad range of joint replacement products including hips, knees, shoulders, ankles, and other extremity prostheses. We provide prosthesis design, education, training and surgical procedure support. Our Pyrocarbon™ radial head system is a modular implant for the reconstruction of the proximal radius. The system consists of a titanium expandable stem, a titanium angled neck, and a pyrolytic carbon articulator head. These components are interchanged to create 40 separate configurations for optimal anatomical fit. The procedure-specific instrument set includes reamers for bone preparation and tools for implant assembly. Our Latitude® total elbow is designed to reproduce the patient's anatomy and restore the natural kinematics of the elbow. The unique instrumentation facilitates a step-by-step procedure that makes elbow arthroplasty accurate, precise and reproducible. It offers maximum flexibility in elbow reconstruction.

FDA Registration Number: 3004983210

49 Products/Services (Click for related suppliers)

• 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 Fixation Staple (FDA Code: JDR / 888.3030)

• 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.

• 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.

• Carpal Trapezium Wrist Prosthesis (FDA Code: KYI / 888.3770)

A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.

• Cement Obturator (FDA Code: LZN / 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.

• Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI / 888.3350)

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (888.3027).

• Constrained Elbow Prosthesis (FDA Code: JDC / 888.3150)

An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).

• Disposable Suture Needle (FDA Code: GAB / 878.4800)

• Endoscope Accessories (FDA Code: KOG)

• General & Plastic Surgery Surgical Mallet (FDA Code: GFJ / 878.4800)

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

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

• Humeral (hemi-shoulder) Metallic Uncemented Prosthesis (FDA Code: HSD / 888.3690)

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (888.3027). This device is not intended for biological fixation.

• Impactor (FDA Code: HWA / 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.

• 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.

• Knee Joint Femorotibial Metal/Polymer Non-constrained Cemented Prosthesis (FDA Code: HSX / 888.3520)

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (888.3027).

• Ligature Passing and Knot Tying Instrument (FDA Code: HCF / 878.4800)

• Medical Rasps (FDA Code: HTR / 878.4800)

• Metal/Polymer Cemented Non-Constrained Shoulder Prosthesis (FDA Code: KWT / 888.3650)

A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (888.3027).

• Metal/Polymer Cemented Semi-Constrained Shoulder Prosthesis (FDA Code: KWS / 888.3660)

A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (888.3027).

• Metal/Polymer Semi-Constrained Ankle Prosthesis (FDA Code: HSN / 888.3110)

An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (888.3027).

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

• Nail/Blade/Plate Component Fixation Appliance (FDA Code: LXT / 888.3030)

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)

• Phalangeal Hemi- Toe Prosthesis (FDA Code: KWD / 888.3730)

A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.

• Polyester Synthetic Non-Absorbable Suture (FDA Code: GAS / 878.5000)

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

• Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT / 878.5000)

• Polymer Constrained Toe Prosthesis (FDA Code: KWH / 888.3720)

A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.

• Polymer Plug Subtalar Prosthesis (FDA Code: MJW / 888.3040)

• Polymer Radial Hemi- Elbow Prosthesis (FDA Code: KWI / 888.3170)

An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.

• Polymeric Surgical Mesh (FDA Code: FTL / 878.3300)

• Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW / 878.5010)

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.

• Reamer (FDA Code: HTO / 888.4540)

• Semi-Constrained Elbow Prosthesis (FDA Code: JDB / 888.3160)

An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).

• Semi-Constrained Patellofemorotibial Knee Prosthesis (FDA Code: JWH / 888.3560)

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).

• Soft Tissue Biodegradable Fixation Fastener (FDA Code: MAI / 888.3030)

• Soft Tissue Non-Biodegradable Fixation Fastener (FDA Code: MBI / 888.3040)

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

• Surgical Mesh (FDA Code: FTM / 878.3300)

• Surgical Punch (FDA Code: LRY / 878.4800)

• Threaded Fixation Pin (FDA Code: JDW / 888.3040)

• Ultrasonic Surgical Instrument (FDA Code: LFL)

• Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LWJ / 888.3360)

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

• Uncemented Metal/Polymer Shoulder Prosthesis (FDA Code: MBF / 888.3670)

A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.

• Wire Cutters (FDA Code: HXZ / 888.4540)

• Wrench (FDA Code: HXC / 888.4540)