AccuFill ® Bone Substitute Material (BSM) for The Subchondroplasty ® (SCP ® ) Procedure A Truly Injectable CaP that Fills Subchondral Defects Without Cavity Creation AccuFill ® BSM Standard “Injectable” BSM Not for Distribution; for Internal Use Only.
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AccuFill Bone Substitute Material (BSM) for The ... · PDF fileAccuFill® Bone Substitute Material (BSM) for The Subchondroplasty® (SCP®) Procedure A Truly Injectable CaP that Fills
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AccuFill® Bone Substitute Material (BSM)for The Subchondroplasty® (SCP®) Procedure
A Truly Injectable CaP that Fills SubchondralDefects Without Cavity Creation
References1. HydroSet Literature - Stryker 2008 90-07900 LOT B1008; HydroSet Literature - Stryker 2006 LHS-B MS/GS 3C 08/06; HydroSet Literature - Stryker 2006 LHS-SS MS/GS 3C 08/06 http://
literature.ortho.stryker.com/files/LHS_SS.pdf2. Larson 2006 Injectable Phosphate Cements – A Review3. Van Lieshout et al. BMC Musculoskeletal Disorders 2011, 12:344. Colon, et al. “Assessment of the injection behavior of commercially available bone BSMs for Subchondroplasty® procedures”, The Knee 2015; 021125. PRO-DENSE® Bone Graft Substitute Mixing Instructions 135703-3; PRO-DENSE® Bone Graft Substitute 133486-10 IFU; ProDense Product guide _ Ortotech Access 2014-05-28; Wright
Medical Product Guide for Bone Graft Substitutes & Soft Tissue Repair SK908-1212; ProDense Website; Wright Medical; 2014
All trademarks protected as registered with their respective companies.
Not for Distribution; for Internal Use Only.
AccuFill® BSM Features and Benefi ts• Injectable Calcium Phosphate (CaP)• Flows readily; fi lls subchondral bone defects without cavity creation• Mimics properties of normal cancellous bone• Undergoes cell-mediated remodeling; resorbed and replaced as the bone heals
MANUFACTURED BY:ETEX675 Mass. Ave, 12th FloorCambridge, MA 02139www.etexcorp.com
CRITERIA FEATURE BENEFIT
Formulation Ca10-x(M)x(PO4)6-x(HPO4,CO3)x(OH)2-x
[(M)=metal ions (e.g. Mg++)]• Mimics chemical structure of natural bone• Facilitates remodeling
Working Time 15 minutes in the OR• Provides long working time before implantation• Maintains “paste” form throughout
Handling, Mixing Readily mixes in AccuMix® Syringe• User friendly• No loss of BSM during mix or transfer• Can be mixed with blood or saline
Injectability Injectable under low pressure;no phase separation
• Requires only digital pressure to inject
Flowability Flows uniformly; no phase separationinto cancellous bone
• No need for surgical void creation, preserves healthy bone• Allows for complete defect fi ll
Irrigatability Hydrophilic; soluble in synovial fl uid • Irrigates easily if extravasation into joint space occurs
Setting Time Endothermically sets in 10 minutes at 37°C• Sets hard after closure• No thermal necrosis
Porosity 65% total porosity (interconnected); 1-300 µm• High surface area facilitates remodeling and bony ingrowth• Facilitates fl uid transfer through the material
Crystalline Structure Amorphous, nanocrystalline; 6 µm average size
• Mimics natural cancellous bone• Supports normal bone metabolism and remodeling
Compressive Strength ~10 MPa • Properties comparable to cancellous bone*
Bioactivity Interdigitates in bone; osteoconductive• Sets hard and maintains shape• Provides continuous osteoconductive scaffold
Remodeling Cell-mediated remodeling • Remodels with new bone growth
Drillability Drillable during and after setting • Procedural fl exibility
*Keaveny, et al, “Bone Mechanics”, Standard Handbook of Biomedical Engineering and Design, McGraw-Hill, 2004, Chap. 8, p11-12.
Zimmer Knee Creations, Inc.841 Springdale DriveExton, PA 19341