Innovative and unique resorbable sheath – Tibial Fixation Device

    Osteotwin™ Sheath is designed to increase soft tissue fixation in ACL reconstruction surgery. Using Osteotwin™ Sheath guarantees superior fixation strength and greater graft protection.*
    Osteotwin™ Sheath is made of 75% of PLDLLA and 25% of MBCP™ Technology.

    Osteotwin™ Resorbable Sheath Design

    Osteotwin Resorbable Sheath Design


    The thread of the resorbable sheath is specific to each screw diameter so as to systematically provide the maximum amount of contact between implant and bone.

    Osteotwin Affix Resorbable Sheath Design

    Indications

    • Resorbable sheath for ACL reconstruction

    Availability

    Diameter x Length in millimeters:
    7 x 8 mm
    9 x 10 mm

    Downloads

    • ISO 13485
    • Read the instruction for use
    • Osteotwin™ is supplied sterile and CE-marked as a Class III Medical Device according to Directive EEC/93/42

    CE 0123

    Daculsi, G., O. Laboux, et al. (2003). «Current state of the art of biphasic calcium phosphate bioceramics.» Journal of Materials Science: Materials in Medicine 14(3): 195-200. -More-
    Middleton, J. C. et al.; Biomaterials 21 (23), «Synthetic biodegradable polymers as orthopedic devices», 2000 2335-2346. -More-
    Suchenski, M., M. B. McCarthy, et al. (2010). «Material Properties and Composition of Soft-Tissue Fixation.» The Journal of Arthroscopic and Related Surgery 26(6): 821-831. -More-
    Uzel, A. P., E. Seris, et al. (2013). «Preclinical and clinical cases of new absorbable composite interference screws in osteoarticular surgery.» Key Engineering Materials 529-530: 325-330. -More-
    Kaeding, C., J. Farr, et al. (2005). «A Prospective Randomized Comparison of Bioabsorbable and Titanium Anterior Cruciate Ligament Interference Screws.» The Journal of Arthroscopic and Related Surgery 21(2): 147-151. -More-
    Hunt, J. A. and J. T. Callaghan (2008). «Polymer-hydroxyapatite composite versus polymer interference screws in anterior cruciate ligament reconstruction in a large animal model.» Knee Surgery, Sports Traumatology, Arthroscopy 16(7): 655-660. -More-
    Weiler, A., H. J. Windhagen, et al. (1998). «Biodegradable interference screw fixation exhibits pull-out force and stiffness similar to titanium screws.» The American journal of sports medicine 26(1): 119-126. -More-
    Weiler, A., R. F. Hoffmann, et al. (1998). «Hamstring tendon fixation using interference screws: a biomechanical study in calf tibial bone.» Arthroscopy: The Journal of Arthroscopic and Related Surgery 14(1): 29-37. -More-
    Black, J., (1988). «Does corrosion matter?» The Journal of Bone and Joint Surgery, 70-B(4): 517-520. -More-
    Bauer, J., Turgay, E., et al. (2010)., «Torsional stability of interference screws derived from bovine bone – a biomechanical study.» BMC Musculoskeletal Disorders 11: 82 -More-
    Uzel, P. A., G. Daculsi, et al, «Utilisation des coins de MBCP™ en traumatologie lors des fractures enfoncement (tibia proximal et distal, calcanéum) : double intérêt de comblement et d’étayage», 13ème Congrès de l’AOLF (2012) -More-
    R. Schouten, G. Hooper, The use of Bone substitute (Triosite) wedges in Medial Opening wedge high tibial osteotomies, 33 Patient clinical study, Journal of Bone & Joint Surgery, British Volume (2009) -More-
    Rouvillain, J.L., Lavalle, F., Pascal-Mousselard, H., Catonne, Y., Daculsi, G., Clinical, radiological and histological evaluation of biphasic calcium phosphate bioceramic wedges filling medial high tibial valgisation osteotomies., Knee (2009) -More-
    Rouvillain, J. L., Pascal-Mousselard, H., Lavalle, F, Garron E., Catonné Y., Daculsi G., MBCP Wedges performance during open medial tibial osteotomy, European conference on biomaterials (2006)
    Lavallé, F., H. Pascal-Mousselard, et al, Biphasic ceramic wedge and plate fixation with locked adjustable screws for open wedge tibial osteotomy, Revue de chirurgie orthopédique (2004) -More-
    * Data on files, Biomatlante

    The fixation provided by the sheath in combination with a screw is temporary until complete consolidation. The device cannot withstand weight-bearing or any other physical effort that does not comply with the postoperative procedure established for this type of surgery. The preoperative and intraoperative procedures, notably the knowledge of surgical techniques as well as the right selection and placement of the device constitute important elements for successful use of this device. Preoperative and intraoperative procedures should be carried out by a competent surgeon. Patients should be informed of the use of this device and the contraindications and potential adverse effects, if any. Internal fixation devices should never be reused, even if they appear to be intact. Any decision to remove the product should take into account the potential risk for the patient. In the event of a second procedure, the removal of the implant should be followed by an adequate postoperative treatment. Please use the insertion guides and the appropriate instruments to place the device in the tibial site. The product is radio-opaque and is considered to be radiotransparent in the sense that it does not affect MRI (Magnetic Resonance Imagery). The product has not been tested on pregnant women. The health risk has not been established.

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