Processed by MTF, designed and available through Synthes Spine Spinal Correction FRA Spacers. Angled and parallel spacers designed for a lateral approach.
Spinal Correction FRA Spacers Two varieties of spinal correction implants: Small Stature FRA Spacer and FRA Spacer with lateral slot. Features Angled and parallel spacers designed for a lateral approach Slots on superior and inferior surfaces facilitate insertion of the implant under distraction Pyramidal teeth on superior and inferior surfaces minimize migration and displacement A range of heights accommodate intervertebral disc spaces within the thoracolumbar spine Extensive donor screening Please refer to package insert for the full list of indications, contraindications, warnings and/or precautions. Synthes Spinal Correction FRA Spacers
Mechanical testing summary The design of the Small Stature FRA (SS FRA) Spacer and FRA Spacer is based on sound engineering principles, extensive research of the anatomy, and mechanical testing to subject the implant to relevant loading. In spinal correction procedures, the role of spacers is to provide anterior column support in conjunction with additional anterior or posterior instrumentation. Compressive strength Tests were conducted to ensure that the SS FRA Spacer and the FRA Spacer could withstand loads in the thoracic and lumbar spine. The ultimate compressive strength of the vertebral body is 8,000 N. 1 The design goal for the FRA Spacer was to achieve compressive strength of at least 8,000 N. Loads greater than this would result in failure of the vertebral body before failure of the implant. Test results show that the SS FRA Spacer and the FRA Spacer each have a compressive strength greater than 25,000 N (Figure 1). 2 Resistance to expulsion Pyramid-shaped teeth are machined on the superior and inferior surfaces of the implant to increase resistance to pushout. Testing was conducted to ensure that the SS FRA and FRA Spacers are capable of resisting expulsion at clinically relevant loads. The maximum shear force that a human disc can withstand is about 150 N. 3 The resistance of the implant to being expelled or pushed out from the disc space was determined by pushout testing. A clinically relevant axial load (450 N) 3 and side load was applied to the implant to determine pushout strength. Test results show that the SS FRA Spacer has a pushout strength of 565 N (Figure 2). Compressive Strength (N) 30,000 25,000 20,000 15,000 10,000 5,000 Figure 1 Load (N) 600 500 400 300 200 100 0 Figure 2 0 Compressive Testing SS FRA Spacer FRA Spacer Pushout Strength Testing SS FRA Spacers (with teeth) Human disc Vertebral Body 1 O. Perey, Fracture of the vertebral endplate in the lumbar spine. Acta. Orthop. Scand. 25 (Suppl.), 1957. 2 Testing performed at the Mechanical Testing Laboratory, Synthes Spine, West Chester, PA. Mechanical Testing #: M797-077. M700-264. Mechanical Testing results are not necessarily indicative of clinical performance. 3 A. A. White and M. M. Panjabi. Clinical Biomechanics of the Spine. Philadelphia. Lippincott, Williams and Wilkins. 1990. 7, 9. Synthes
Spinal Correction FRA Spacers FRA Spacer, small stature Parallel Angled, Lateral (4 ) Height Item Number Item Number 6 mm 011806 011906 7 mm 011807 011907 8 mm 011808 011908 9 mm 011809 011909 10 mm 011810 011910 11 mm 011811 011911 Overall dimensions Lateral approach with a small stature FRA Spacer being implanted at the T10 T11 junction AP depth 19 mm H 4º ML width 19 mm SS FRA parallel spacer SS FRA angled lateral spacer* * Tallest side denoted by etched line on product (not visible in image) Height measured from top of teeth, as shown Synthes Spinal Correction FRA Spacers
FRA Spacer (with lateral slot) Parallel Angled, Lateral (8 ) Height Item Number Item Number 9 mm 010409 010509 11 mm 010411 010511 13 mm 010413 010513 15 mm 010415 010515 17 mm 010417 010517 19 mm 010419 010519 21 mm 010421 010521 Overall dimensions Lateral approach with an FRA Spacer being implanted at the L2 L3 junction AP depth 23 mm 27 mm H 8º ML width 24 mm 32 mm FRA parallel spacer FRA angled lateral spacer* * Tallest side denoted by etched line on product (not visible in image) Height measured from top of teeth, as shown Synthes
Musculoskeletal Transplant Foundation (MTF) Synthes has partnered exclusively with the Musculoskeletal Transplant Foundation (MTF) for over 10 years to provide high quality tissue for patients. Although there are national standards for tissue banks, they only set a baseline for the industry. Beyond that, regulations leave a lot to interpretation, so standards vary significantly from tissue bank to tissue bank. MTF offers safe allografts processed from among the most carefully selected donors. MTF s standards are set by their Medical Board of Trustees more than 40 surgeons from world-renowned academic institutions. Directed by Surgeons MTF utilizes a Medical Board of Trustees comprised of more than forty surgeons from world-renowned academic institutions. MTF s board sets standards, which are among some of the most stringent in the industry. Selecting the Ideal Donor MTF s extensive network of participating organ procurement organizations ensures that MTF has access to a broad selection of qualified donors. MTF holds itself to stringent standards for donor selection and processing criteria. MTF defers more donors than they accept. MTF Donor Deferral Rate > 97% deferred < 3% accepted Preserving and Protecting Tissue Integrity MTF s approach ensures a high level of safety, without compromising biological and mechanical integrity. MTF has developed and validated several tissue cleaning technologies to provide safe and high quality allograft bone. Allograft bone processed by MTF may result in improved incorporation in humans when compared to allograft bone processed from other sources based on results of in vivo testing*. Since MTF s inception, MTF has maintained an exemplary safety record distributing almost 4.2 million allografts from nearly 80,000 donors. *Dunn M.G, 2008. Effect of Allograft Bone Processing on Structural Cortical Grafts: A Comparison of three proprietary processing Methods. Synthes Spinal Correction FRA Spacers
Available through Synthes Spine 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order call: (800) 522-9069 Fax: (877) 534-1560 www.synthes.com Processed by Musculoskeletal Transplant Foundation 125 May Street Edison, NJ 08837 Telephone: (732) 661-0202 Fax: (732) 661-2298 2000 Synthes, Inc. or its affiliates. All rights reserved. Synthes is a trademark of Synthes, Inc. or its affiliates. Printed in U.S.A. 2/11 J3377-E