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The Acumed Wrist Fusion Plate, an addition to the Acumed Congruent Bone Plate System, is designed specifically for fusion of the small bones of the hand including: hamate, capitate, lunate, triqueteral and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.

The Acumed Wrist Fusion Plate is spherical in shape. Holes or slots offer multiple screw placement options. The plate also has holes that may be utilized for provisional tacking or positioning with Kirschner wires to the bones prior to screw installation. A threaded hole in the center of the plate allows for optional accessories to be attached to the plate.

The Polarus Cap Screw is intended to be used in conjunction with the Polarus Humeral Rod. It engages the 5.0 mm proximal screw in the rod to prohibit / minimize the screw from backing out and to prohibit the in growth of bone into the 1/4-20 hole.

The Polarus Cap Screw is intended to be used in conjunction with the Polarus Rod family cleared under K920666 and K951740. Its purpose is to engage the proximal-most 5.0 interlocking screw in the rod 10 prohibit/minize backing out of that screw and to prohibit ingrowth of bone into the 1/4-20 hole. The Polarus Cap Screw is manufactured from two different materials. The cap is manufactured from a titanium alloy per ASTM F 136 and the tip portion is manufactured from medical grade polyethylene per ASTM F 648. The Polarus Cap Screw is provided sterile and is packaged in inner and outer PETG blisters with Tyvek lids. Sterility is achieved by a minimum of 2.5 megarads gamma radiation. Verification of sterility is performed using the AAMI - Method 1. Sterility assurance level is 104. We make no claims as to the pyrogenicity of this product. Instrumentation is provided nonsterile in a tray. On file at Acumed is data which shows that the instrumentation can be successfully steam sterilized under specific process parameters which will obtain a resulting SAL of 104.

The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.

The Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. Each of the plate styles utilizes the same screw types and screw instruments for insertion. All of the plates and screws are manufactured from titanium and are provided non-sterile. The screws were cleared for marketing and distribution under K942340 and K942341.

Addresses proximal fractures when used with interlocking screws and arthritis of the shoulder joint.

The Acumed Modular Shoulder System is a semi-constrained modular component designed to address proximal fractures when used with interlocking screws and arthritis of the shoulder joint to with or without bone cement. It incorporates a cobalt chrome modular head, a titanium body, and a selles of the components may be mixed and matched in order to best duplicate the patient's anktomy. Several strategic holes for suturing are in the body the surgeon to tie down the greater- and lesser-tuberosities, which are frequently displaced during these types of fractures. Interlocking screws identical to those cleared by K942340 Cortical Boxe Screws are intended to provide rotational interlocking with the stems are cannulated and are intended to facilitate placement of the component over a previously inserted gtride wire. The component sizing and the geometrical placement of the head and stem are intended to allow the surgeon to duplicate the anatomic posterior offset in the humeral head. Targeting instrumentation is provided to allow accurate of the screws through the component.

This device is intended for anchoring soft tissue to bone in soft tissue repair of the foot and ankle and rotator cuff repair.

The Acumed Suture Anchor is a single use implantable device used with non-absorbable, noncoated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs as cleared by 510(k) submission K980103 and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F136 and is provided non-sterile.

This device is intended for anchoring soft tissue to bone in rotator cuff repairs of the shoulder and soft tissue repair of the foot and ankle.

The Acumed Suture Anchor is a single use implantable device used with non-absorbable, non-coated white or green #2 or #0 braided polyester suture to anchor soft tissue to bone in rotator cuff repairs and soft tissue repairs of the foot and ankle. The suture anchor is manufactured from titanium 6AL 4V ELI per ASTM F 136 and is provided non-sterile.

The Acumed Suture Washer is intended for soft tissue fixation, small bone fixation, and large bone fixation and may be used in conjunction with a 3.5mm or 4.0mm titanium bone screw and suture. This device is not intended for usage in the spine.

This washer has a post height of 2.6mm and an outer diameter of 8.0mm. The Extremity Screw is manufactured from a titanium alloy per ASTM F 136 and is provided sterile. Sterility is achieved by a minimum of 2.5 Mrads gamma radiation. Verification of sterility is performed with the AAMI - Method 1. Sterility assurance level is 104.

The Stableloc II External Fixation System is used to address Colles' fractures and distal radial osteotomies and is not intended for use in the spine.

The Stableloc II External Fixation System consists of an external fixation device and a selection of threaded guide pins. The external fixator is not intended for implantation, only as a tool in surgery. It holds in place the pins which provide fracture reduction and alignment. The Stableloc II External Fixation System is manufactured from Ultem, aluminum, stainless steel, and titanium while the guide pins are made from stainless steel per ASTM F 138. The external fixator is provided non-sterile. Acumed has identified a set of process parameters for steam sterilization which provide an SAL of 106 as validated by data on file at Acumed. The guide pins are provided sterile. Sterility is achieved by a minimum of 2.5 megarads gamına radiation. Verification of sterility is performed with the AAMI - Method 1. Sterility level is 10th. We make no claims as to the pyrogenicity of this product. Information regarding packaging and labeling has been provided.

The Acumed Tension Band Pin is used in conjunction with orthopedic wire to address malleolar, patella, and oleacranon fracture fixation in tension band wiring procedures. This device is not intended for usage in the spine.

This device has a diameter of .0625" and is available in lengths of 35mm, 45mm, and 55mm. The Acumed Tension Band Pin is manufactured from 316L stainless steel and is provided pre-sterile. Sterility is achieved by a minimum dose of 2.5 megarads of gamma radiation. Validation of sterility is maintained on site. Sterility level is10.4. Information regarding packaging and labeling have been provided.

addresses humeral fractures

an intramedullary rod which addresses humeral fractures. The nail is 8 mm in diameter and is available in a lengths of 200 mm, 240 mm, 260 mm, 280 mm, and 300 mm. It is used in conjunction with 3.5 mm interlocking screws. The Acumed Retrograde Humeral Nail is manufactured from titanium per ASTM F 136. This device is provided pre-sterile. Sterlity is achieved by gamma radiation.