Bone Void Filler. Callos. The Next Generation in Calcium Phosphate Cement A COLSON ASSOCIATE

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1 Callos Bone Void Filler The Next Generation in Calcium Phosphate Cement A COLSON ASSOCIATE

2 Callos Calcium Phosphate Cement Callos is a high performance next generation calcium phosphate cement indicated for filling bony defects in cancellous bone. This material was designed to overcome the limitations of the first calcium phosphate cements. First generation cements had good compression strength, but were weak in tension, flexural strength and fracture toughness, which combined with poor handling properties, have limited their use in fracture fixation. Callos is available in two forms: Callos Impact moldable cement Callos Inject injectable cement Advantages Biocompatible Allows for natural bone remodeling, or healing, while still maintaining the strength of cancellous bone Callos Impact Easy to mix and deliver with supplied mixing system Fast, hard-setting; approximately 5 minutes at 37 C in wet environment Immediate higher compressive strength than cancellous bone Can be drilled and inserted with screws May be implanted before or after hardware allowing surgeons to maintain their standard surgical technique and allowing precise cement and hardware placement Can be mixed with autograft as autograft extender Callos Inject

3 Clinical Applications Simple voids in metaphyseal bone, (small tumors, cysts, defects) Traumatic fractures that result in bone voids in metaphyseal areas Fractures of the: Distal Radius (Colles) Proximal Humerous Pelvic Bone Proximal Femur (Intertroch, Femoral Neck) Distal Femur Tibial Plateau Tibial Pilon Calcaneus Osteotomies (Distal Radius, Tibial Plateau) All Oncological applications Revision Total Joints Iliac Crest back fill Autograft extender

4 Science Drillable Osteoconductive Scaffold Composition Bone remodeling is the healing process whereby old bone is naturally removed and replaced with new bone. Callos is similar in composition to the mineral phase of bone. A calcium phosphate starting powder is reacted with diluted silicate liquid, and undergoes a non-exothermic chemical reaction to form low crystalline hydroxyapatite, which hardens in vivo to create an Osteoconductive scaffold. Bony ingrowth occurs through the same cell mediated process as the patient s natural bone remodeling. Callos is optimal as a filler for metaphyseal defects due to its high immediate mechanical strength and ability to maintain that strength long term throughout the healing process. Patterns show X-ray diffraction showing Callos and bone have the same chemical and crystalline composition. Histology Histology analysis demonstrated that Callos is highly biocompatible and osteoconductive. Histological sections were examined following four weeks and six months in vivo and showed extensive bone apposition with no adverse tissue reaction. Normal bone remodeling by localized osteoclastic, cell mediated resorption coupled with new bone formation within the implanted area was a consistent finding in areas implanted with Callos. Figure 1 Femoral specimen implanted with bone cements after one month. Formation of several Haversian canals were observed in and around the implanted region. (Trichrome staining) Figure 2 Femoral Specimen implanted with Callos after six months at low (left) and high (right) magnification. Mature Haversian canals were seen in areas where Callos was originally implanted. (HE staining)

5 Biomechanical Analysis A clinically relevant understanding of long-term strength of defects treated with calcium phosphate bone void fillers (or any other bioactive material) are appropriately evaluated only in vivo. An in vivo biomechanical study was performed at four weeks and six months postimplantation to assess the in vivo strength of cancellous bone defects treated with Callos bone void filler during replacement by native cancellous bone. Callos is radiopaque and is visible under flouroscopy to allow proper placement of hardware and to ensure the cancellous defect has been completely filled. Callos can be drilled and inserted with a screw to optimize use of the combination of hardware Load (Newton) Callos 4 weeks and cement, essential in treating periarticular fractures. Callos Impact can accept hardware after a setting time of 6 minutes in vivo, and Callos Inject can accept 311 Callos 6 months 130 Bone (Control) An in vivo study shows Callos maintains strength above cancellous bone as it gets remodeled. hardware after setting a time of 10 minutes in vivo. Callos should be drilled only with fluted bits or screws. Remodeling Case Study Pre-op shows the calcaneus void after fracture Post-op image shows the amount of Callos implanted. Remodeling of Callos is evidenced by reduction in density of the implanted area. As material continually remodels, radiographic evidence of the implanted area returning to trabecular structure.

6 Indications and Case Trauma Tibial Plateau Fracture Pre-op CT shows low energy Tibial Plateau fracture Post-op X-ray shows the fixation by plating and Callos implantation Distal Radius Fracture Pre-op X-ray showing on extra-articular fracture. Lateral view shows Callos implantation in both dorsal and volarside of distal radius. Post-op image of implantation of Callos with K-wires. Calcaneus Fracture Post-op lateral image of calcaneus shows fixation with plate and Callos. 10cc Implant Post-op AP view shows the location of implanted Callos. 10cc Implant

7 Studies any body copy? Total Joint Revision Pre-op view shows extensive osteolysis in both compartments of tibial bone underneath the tibial tray. Intra-op view of filling the bony voids with Callos. Post-op view of Callos implant and new total knee joint has been inserted. Oncology Pre-op MRI view of atypical bone cyst. Post-op radiograph shows complete filling of the defect in calcaneus. Giant cell tumor of tibia. Radiographic view shows complete filling with Callos. Approximately 80cc of material was used.

8 Ordering Information CALLOS INJECT CALL-0003 Callos Inject (MX), 3cc Rotary Mixer configuration CALL-0005 Callos Inject (MX), 5cc Rotary Mixer configuration CALL-0010 Callos Inject (MX), 10cc Rotary Mixer configuration Inject Contents: Callos Mixer System (Mixer, Plunger, & Syringe), Cannula, Callos Inject Powder and Liquid Set CALLOS IMPACT CALL-0105 Callos Impact (MX), 5cc Rotary Mixer configuration CALL-0110 Callos Impact (MX), 10cc Rotary Mixer configuration Impact Contents: Callos Mixer System (Mixer, & Spatula), Callos Impact Powder and Liquid Set References 1. Improved Flexural Strength of a Novel Craniomaxillofacial Cement Lin, J; Yetkinler, D N; Delaney, D; Nguyen, H; Constantz, B R Orthopaedic Research Society Transactions Vol.30, Washington, D.C., Optimization of the Osteoinductiveness and Mechanical Properties of Calcium Phosphate Bone Cement using Demineralized Bone Matrix Banki, P; Karkar, V; Somayaji, S Orthopaedic Research Society Transactions Vol.29, San Francisco, California, In Vitro and In Vivo Evaluation of Two Calcium Phosphate Cements Yetkinler, D N; Delaney, D; Constantz, B R Orthopaedic Research Society Transactions Vol.29, San Francisco, California, Increased Fracture Toughness Improves Clinical Utility of a Novel Calcium Phosphate Cement Lin, J; Lee, WJ; Yetkinler, DN; Constantz, BK; Orthopaedic Research Society Transactions Vol. 31, Chicago, Illinois 5. Lateral Tibial Plateau Fracture Split Depression Fracture Repairs Augmented with Calcium Phosphate Cement Have Higher In Situ Fatigue Strength than those with Autograft. McDonald E, Chu T, Tufaga M, Marmor M, Singh R, Yetkinler D, Matityahu A, Buckley JM, McClellan RT. Journal of Orthop Trauma, 2011;25(2): Calcium Phosphate Cements Improve Bone Density When Used in Osteoporotic Sternums Muehrcke, DD; Shimp, Aponte-Lopez, WM Annuals of Thoracic Surgery, 2009; 88: Hydroxyapatite cement resistant to fragmentation following full cerebrospinal fluid bathing Muhonen MG, Lonyai A, Westhout FD. Journal of Craniofacial Surgery (1): Biomechanical Evaluation of a 1-Stage Revision Anterior Cruciate Ligament Reconstruction Technique Using a Structural Bone Void Filler for Femoral Fixation Vaughn Z, Schmidt J, Lindsey D, Dragoo J. Journal of Arthroscopic and Related Surgery, 2009;25: In vivo assessment of Callos/OsteoVation calcium phosphate cement containing autologous bone S. Jalota, D. C. Delaney and D.N. Yetkinler; Annual Meeting, Society for Biomaterials, April 21 25, 2010, Seattle, WA. A COLSON ASSOCIATE Skeletal Kinetics LLC Bubb Road Cupertino, CA USA LBL Rev AD

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