Abstract: The present disclosure relates to systems and methods for treatment using syndesmosis fixation. More specifically, syndesmosis fixation is provided with physical features produced from a citrate-based composite biomaterial to aid in healing of the syndesmotic ligament.

Abstract: A synthetic rotator cuff repair scaffold/patch system fabricated from citrate-based materials is provided. The biodegradable scaffold/patch system includes (i) a citrate component and/or other carboxylic acid components, (ii) a polyol, and (iii) particulate inorganic material. The patch system includes a patch that defines a patch thickness and may define a porosity gradient across the patch thickness.

Abstract: A citrate composition is provided for use in 3D printing of end products, e.g., scaffolds. The disclosed composition incorporates water soluble salts and/or sugars into a pre-polymer to improve the viscosity for 3D printing, increase the porosity of the resulting scaffold, and improve the handling of the citrate based bioceramic compositions.

Abstract: The present disclosure provides anionic citrate-based composition for use in regenerative applications. The disclosed composition may take the form of a scaffold and generally includes (i) a citrate component, (ii) a diol, and (iii) an anionic moiety. The anionic moiety may include one or more of a sulfate, sulfonate, phosphate, phosphonate, sulfamate, or carboxylic acid, The sulfate and/or sulfonate containing moiety may be conjugated via an amidation reaction, esterification, and/or substitution reaction with a sulfur trioxide complex. A peptide may be conjugated to a surface of the composition.

Abstract: Charged citrate-based compositions are provided for use in regenerative applications. The disclosed compositions generally include (i) a citrate component, (ii) a diol, and/or (iii) a charged moiety. The compositions may be used to fabricate scaffolds. The citrate component may take the form of citric acid, citrate, or ester of citric acid, the polyol may take the form of a diol, such as butanediol, hexanediol, octanediol, glycerol or xylitol, and the charged moiety is an anionic or cationic moiety. The anionic moiety may take the form of sulfate, sulfonate, phosphate, phosphonate, sulfamate, or carboxylic acid, and the cationic moiety may take the form of quaternary ammonium, pyridinium, piperidinium, pyrrolidinium, imidazolium, or phosphonium. The anionic or cationic moiety can be presented in the polyol. The composition may include a particulate inorganic material, such as hydroxyapatite, tricalcium phosphate, biphasic calcium phosphate, or bioglass.

Abstract: Grafting materials are disclosed that are fabricated from citrate-based materials. The grafting materials have particular applicability in forming a biodegradable scaffold and generally include a composition that includes (i) a citrate component, (ii) a polyol, and (iii) particulate inorganic material. The polyol may take the form of a diol, e.g., butanediol, hexanediol, octanediol, or polyethylene glycol. The scaffold may take the form of a crosslinked polymer network, may be biodegradable, and may be 50-90% porous. The scaffold may be conformable and may be adapted to be cut in an operating room.

Abstract: The present disclosure provides citrate-based constructs for use in the repair of osteochondral defects. The constructs generally include: (i) a citrate component, (ii) a diol component, (iii) a polyol, and (iv) particulate inorganic material. The scaffold may take the form of a 50-90% porous scaffold and may form a polymer network. The scaffold may be soaked in a hyaluronic acid solution and may be freeze-dried to produce a porous construct within the pores of the scaffold. The scaffold may be biphasic, containing a porous section for subchondral bone regeneration and a citrate-based polymer hydrogel for cartilage regeneration. The scaffold may form an implant and the implant may include an inner porous core of a biphasic core-shell construct.

Abstract: A patch system and method for musculoskeletal repair is provided, the patch system including a patch that defines a patch thickness, the patch fabricated, in whole or in part, from a composition that includes a citrate polymer and a bioceramic filler, and wherein the patch defines a porosity gradient across the patch thickness. The patch may be defined by a plurality of patch layers, e.g., patch layers formed from a plurality of fibers, and first fibers associated with a first patch layer are non-aligned relative to second fibers in a second, adjacent patch layer.

Abstract: Graft tensioning systems and associated engagement assemblies are provided. The engagement assemblies include at least one engagement element or foot that is configured to engage with tissue adjacent or opposed to an implant-receiving opening. The engagement element(s) support stable interaction between the graft tensioning system and the anatomical target region, while reducing the potential for tissue bruising/trauma/contusions. The engagement elements may be interchangeably mounted relative to the graft tensioning device, e.g., intraoperatively, to permit a surgeon to select an engagement element offering desired properties for the specific procedure and/or anatomical properties of the patient.

Abstract: The present invention provides an anchor system for musculoskeletal applications, e.g., for anchoring tendons or ligaments to bone or anchoring two or more bone sections. The anchor system comprises a substantially solid pre-manufactured distal portion (i.e., anchor component) and a settable, biodegradable composite. The biodegradable composite is flowable at the time of delivery and is introduced into the fixation site before or after the anchor component. Both the anchor component and the biodegradable composite may be manufactured from citrate-based polymers.

Abstract: The present disclosure provides advantageous interference anchor. More particularly, an advantageous tendon interference anchor configured to be inserted through impaction. The tendon interference anchor may include an anchor body having a proximal end, distal end, longitudinal axis, and an outer surface and at least one protrusion extending outwardly from the outer surface of the anchor body in a direction non-parallel to the longitudinal axis of the anchor body.

Abstract: The present invention provides an anchor system for musculoskeletal applications, e.g., for anchoring tendons or ligaments to bone or anchoring two or more bone sections. The anchor system comprises a substantially solid pre-manufactured distal portion (i.e., anchor component) and a settable, biodegradable composite. The biodegradable composite is flowable at the time of delivery and is introduced into the fixation site before or after the anchor component. Both the anchor component and the biodegradable composite may be manufactured from citrate-based polymers.

Abstract: Biodegradable and bioabsorbable anchors and anchor systems for use in musculoskeletal fixation applications comprising (1) an anchor body comprising a longitudinal axis, a proximal end, a distal end, an outer surface, and a bore extending from the proximal end and parallel to the longitudinal axis, wherein the bore defines an inner surface of the anchor body, and wherein at least a portion of the anchor body is expandable in a direction non-parallel to the longitudinal axis, and (2) an expansion pin comprising a longitudinal axis, a proximal end, a distal end, and a surface, and configured for insertion into the bore such that, when inserted, it expands the expandable portion of the anchor body in a direction non-parallel to the longitudinal axis. Both the disclosed anchors and anchor systems are at least in part formed from a citrate-based polymer.

Abstract: Joint resurfacing and/or replacement devices, systems and methods that include thin film ternary ceramic coatings that are effective to provide reliable articulation and bearing surfaces and protection of both articular and modular junction surfaces from the potential for corrosion, wear, and fretting, and reduce the potential for release of metal ions from the joint systems. Isoelasticity is provided according to the particular joint resurfacing/replacement devices, systems and methods based on parameters that include material of construction, porosity and coating system. The thin film ternary ceramic coatings may be functionalized to enhance hydrophilicity and may be employed in any anatomical articulating joint region. Titanium alloy composite structures are provided that include an ultra-porous structured titanium alloy bone fixation surface and an opposed solid articular surface and a thin film ternary ceramic coating applied to one or both opposed surfaces.

Abstract: Joint resurfacing and/or replacement devices, systems and methods that include thin film ternary ceramic coatings that are effective to provide reliable articulation and bearing surfaces and protection of both articular and modular junction surfaces from the potential for corrosion, wear, and fretting, and reduce the potential for release of metal ions from the joint systems. Isoelasticity is provided according to the particular joint resurfacing/replacement devices, systems and methods based on parameters that include material of construction, porosity and coating system. The thin film ternary ceramic coatings may be functionalized to enhance hydrophilicity and may be employed in any anatomical articulating joint region. Titanium alloy composite structures are provided that include an ultra-porous structured titanium alloy bone fixation surface and an opposed solid articular surface and a thin film ternary ceramic coating applied to one or both opposed surfaces.

Abstract: Joint resurfacing and/or replacement devices, systems and methods that include thin film ternary ceramic coatings that are effective to provide reliable articulation and bearing surfaces and protection of both articular and modular junction surfaces from the potential for corrosion, wear, and fretting, and reduce the potential for release of metal ions from the joint systems. Isoelasticity is provided according to the particular joint resurfacing/replacement devices, systems and methods based on parameters that include material of construction, porosity and coating system. The thin film ternary ceramic coatings may be functionalized to enhance hydrophilicity and may be employed in any anatomical articulating joint region. Titanium alloy composite structures are provided that include an ultra-porous structured titanium alloy bone fixation surface and an opposed solid articular surface and a thin film ternary ceramic coating applied to one or both opposed surfaces.

Abstract: Joint resurfacing and/or replacement devices, systems and methods that include thin film ternary ceramic coatings that are effective to provide reliable articulation and bearing surfaces and protection of both articular and modular junction surfaces from the potential for corrosion, wear, and fretting, and reduce the potential for release of metal ions from the joint systems. Isoelasticity is provided according to the particular joint resurfacing/replacement devices, systems and methods based on parameters that include material of construction, porosity and coating system. The thin film ternary ceramic coatings may be functionalized to enhance hydrophilicity and may be employed in any anatomical articulating joint region. Titanium alloy composite structures are provided that include an ultra-porous structured titanium alloy bone fixation surface and an opposed solid articular surface and a thin film ternary ceramic coating applied to one or both opposed surfaces.