Abstract: The invention provides a method for the preparation of bone-polymer composites wherein the mineral portion of the bone is treated with a coupling agent before being incorporated into a biocompatible polymeric matrix. The resulting composites may be used as such or be further processed to form an osteoimplant.

Abstract: A composite osteoimplant. The osteoimplant includes a polymer and bone-derived particles. The composite is adapted and constructed to be formable during or immediately prior to implantation and to be set after final surgical placement.

Abstract: The invention provides a method for the preparation of bone-polymer composites wherein the mineral portion of the bone is treated with a coupling agent before being incorporated into a biocompatible polymeric matrix. The resulting composites may be used as such or be further processed to form an osteoimplant.

Abstract: A method of manufacturing an osteoinductive osteoimplant is provided which comprises the steps of: demineralizing part or all of at least one surface of a monolithic section of cortical bone to a depth of at least about 100 microns; and, configuring the monolithic section of cortical bone to provide an osteoimplant possessing an outer surface possessing at least one demineralized zone and a non-demineralized zone. An implant produced according to the above method demonstrates improved osteoinduction without producing any clinically significant reduction of strength in critical regions of the osteoimplant.

Abstract: An improved demineralized bone matrix (DBM) or other matrix composition is provided that has been mixed with a stabilizing agent that acts as (1) a diffusion barrier, (2) a enzyme inhibitor, (3) a competitive substrate, or (4) a masking moiety. A diffusion barrier acts as a barrier so as to protect the osteoinductive factors found in DBM from being degraded by proteolytic and glycolytic enzymes at the implantation site. Stabilizing agents may be any biodegradable material such as starches, modified starches, cellulose, dextran, polymers, proteins, and collagen. As the stabilizing agents degrades or dissolves in vivo, the osteoinductive factors such as TGF-?, BMP, and IGF are activated or exposed, and the activated factors work to recruit cells from the preivascular space to the site of injury and to cause differentiation into bone-forming cells. The invention also provides methods of preparing, testing, and using the inventive improved osteodinductive matrix compositions.

Abstract: A bone fastener for stabilizing bone fragments includes a single or multiple components coupleable with one another and displaceable to a locked position of the bone fastener.

Abstract: The present invention is directed to an impact-absorbing member for use with an implant insertion instrument and the placement of an implant in a recipient's body. Preferably, the implant is a spinal implant for insertion into the intervertebral space. The impact-absorbing member may be attached to the implant insertion instrument, the implant, or both. The impact-absorbing member reduces the impact forces on the implant during placement.

Abstract: An osteogenic osteoimplant in the form of a flexible sheet comprising a coherent mass of bone-derived particles, the osteoimplant having a void volume not greater than about 32% and a method of making an osteogenic osteoimplant having not greater than about 32% void volume, the method comprising: providing a coherent mass of bone-derived particles; and, mechanically shaping the coherent mass of bone-derived particles to form an osteogenic osteoimplant in the form of a flexible sheet.

Abstract: A cortical bone implant is formed of two or more planks of bone which are connected with one or more offset pins. The pins may be right circular cylinders inserted into a corresponding offset bore which offset bends the inserted pin. The bending creates compression and tensile loads in the pin which loads creates friction compression forces on the planks connecting them to the pins by friction. The pins may have different shapes to form the offsets and different configurations for friction attachment to the planks. The implants may be formed of flat or L-shaped planks or bones formed into other shapes including interlocking arrangements. Processes and fixtures are disclosed for forming the pins, planks and implants. Various embodiments of the pins, planks, implants and processes are disclosed.

Abstract: A calcium phosphate bone graft material comprising an amorphous calcium phosphate glassy phase of from about 30 to about 100 volume % is obtained by plasma spraying calcium phosphate-containing powder onto a target to produce a deposited layer and removing the deposited layer from the target to provide the calcium phosphate bone graft material.

Abstract: An osteoimplant comprises a solid aggregate of bone derived elements, adjacent bone-derived elements being bonded to each other through chemical linkages between their adjacent surface-exposed collagen. Various other components can be incorporated into the bone implant material such as bone-growth inducing substances.

Abstract: An osteogenic osteoimplant in the form of a flexible sheet comprising a coherent mass of bone-derived particles, the osteoimplant having a void volume not greater than about 32% and a method of making an osteogenic osteoimplant having not greater than about 32% void volume, the method comprising: providing a coherent mass of bone-derived particles; and, mechanically shaping the coherent mass of bone-derived particles to form an osteogenic osteoimplant in the form of a flexible sheet.

Abstract: An instrumentation system, configured to place adjacent vertebrae at a fixed distance and desired spatial position relative to each other, includes a guide frame guiding an endplate preparation instrument into a disc space between the opposing endplates of the adjacent vertebrae so that the treated surfaces of the endplates define the disc space of the desired shape.

Abstract: Methods of repairing a joint formed by at least two bone sections are provided wherein a biocompatible osteogenic band fabricated from an osteogenic biological material such as bone, tendon, ligament and collagen is affixed to two or more bone sections.

Abstract: A spinal implant tool comprises a steel shaft bifurcated into shaft portions at one end at which a pair of extensions extend from the bifurcated shaft portions. The extensions are flat members which extend from an implant impact element at the end of each of the shaft portions. A spinal bone implant is inserted between the extensions. A shaft portion displacement member has a stud threaded to one of the shaft portions and a knob head for capturing the other shaft portion to the member threaded stud. When the knob is rotated the shaft members are moved apart or closer together. A stop member limits the spread apart distance of the shaft portions.

Abstract: A dowel insertion tool includes a T-shaped handle and a hollow sleeve which extends distally from the T-shaped handle. A shaft extends from the handle through the hollow sleeve and includes a transverse extension. A rotatable knob having an annular channel positioned to receive the transverse extension is supported adjacent the handle. A pin is secured to the knob and extends into a helical camming channel formed in the sleeve. Upon rotation of the knob, the pin moves within the camming channel to move the knob longitudinally about the sleeve. Movement of the knob effects longitudinal movement of the shaft. A support plate is secured to the distal end of the shaft. A pair of prongs are slidably secured to the plate. Each of the prongs includes an enlarged head portion which is slidably positioned within a slot formed in the plate. A guide member is secured to the distal end of the sleeve. The guide member includes a pair of guide bores dimensioned to receive a distal end of the prongs.

Abstract: A C-shaped or ring shaped implant formed of cortical bone has its C-shaped or inner channel filled with a bone promoting material which is preferably demineralized bone fibers formed as a flexible wet sheet or may be cancellous bone, pressed bone fibers formed from demineralized cortical bone chips soaked in acid, or a flex material formed of demineralized bone growth promoting bone fibers. The discrete bone filler element may be secured by a bonding agent, pins or screws, metal, polymer or bone material. The bone filler material is preferably bonded by filling a section of a long bone medullary cavity with wet bone fibers and then drying the fibers to bond them to the outer bone. A filled bone ring may be sliced to form annular filled sections which are then divided into mirror image C-shaped halves each forming an implant. Flex material of compressed bone fibers may be formed with an opening shaped to receive a cortical bone implant element having a C-shaped channel.

Abstract: A load-bearing osteoimplant, methods of making the osteoimplant and method for repairing hard tissue such as bone and teeth employing the osteoimplant are provided. The osteoimplant comprises a shaped, coherent mass of bone particles which may exhibit osteogenic properties. In addition, the osteoimplant may possess one or more optional components which modify its mechanical and/or bioactive properties, e.g., binders, fillers, reinforcing components, etc.

Abstract: An insertion tool for a C-shaped bone spinal wedge shaped intervertebral implant comprises an outer shank with a hollow core in which is placed a shaft with a threaded stud which passes through a bore in the shank at an implant insertion end of the shank. A flat extension member defines a plane and extends from the shank overlying the stud, the stud for receiving a threaded bore of the spinal implant. The shaft has a knob distal the stud for rotatably attaching the stud to the implant. The extension member abuts the implant at mating flat surfaces which are spaced by a medial recess formed by a portion of the medullary canal of a long bone. A cap slides over the shank at an end opposite the extension member to capture the shaft in the shank core. A guide rod is attached to a collar on the shank normal to the plane of the extension member to assist the surgeon in orienting the implant to the disc space orientation during insertion of the implant.

Abstract: An intervertebral spacer formed of dense cancellous human or animal bone is provided. In one preferred embodiment, the intervertebral spacer includes at least one bore which is dimensioned to receive a plug formed from cortical bone tissue. The cortical bone plug provides increased mechanical strength to the intervertebral spacer. Instrumentation for gauging the size of an intervertebral receiving bed and for grasping and inserting an intervertebral spacer or implant into an intervertebral receiving bed are also provided. These instruments include a spacer trial or set of spacer trials for determining the appropriate size spacer required for a particular surgical procedure, a spacer introducer for grasping and positioning a spacer at least partially within a receiving bed formed in the intervertebral space, and a bone tamp for driving a spacer into the receiving bed. Any one or all of these instruments may be provided in a kit for inserting an implant into the intervertebral space.