SYNFIX^®  EVOLUTION System

*except for symmetric 6° implant
1. Aebi M, Arlet V, Webb JK (2007): AOSPINE Manual (2vols), Stuttgart, New York: Thieme
2. Ardern DW, Wilby MJ, LaRue BG, Tizzard S, Morcom R.K., Hall DJ, Cain CMJ (2008) Clinical and radiological outcomes of the stand-alone anterior lumbar interbody fusion used to treat discogenic pain: Two year results of the SYNFIX-LR device. Poster presented at international society for the study of the lumbar spine LSSLS Department of Orthopaedics of Trauma, Royal Adelaide Hospital & St. Andrews Hospital, Adelaide, South Australia.
3. Cain CMJ, Schleicher P, Gerlach R, Pflugmacher R, Scholz M, Kandziora F (2005): A new stand-alone ALIF device: Biomechanical comparison with established fixation methods. Spine 30(23): 2631-6
4. Freeman A, Walker J, Fenn M, Bushelow M, Cain C. Tsantrizos A (2016): Biomechanical comparison of stand-alone anterior lumbar interbody fusion devices with secured fixation: Four-screw locking plate vs Three- screw variable angle vs. blade fixation. ISASS, Las Vegas, NV. 
5. Müller ME, Allgöwer M, Schneider R, Willenegger H (1995): Manual of Internal Fixation. 3rd, exp. a. completely rev. ed. 1991. Corr. 3rd printing. Berlin, Heidelberg, New York: Springer
6. Schleicher P, Gerlach R, Schär B, Cain CMJ, Achatz W, Pflugmacher R, Haas NP, Kandziora F (2008): Biomechanical comparison of two different concepts for stand-alone anterior lumbar interbody fusion Eur Spine 17:1757-1765
7. Siepe CJ, Stosch-Wiechert K, Heider F, Amnajtrakul P, Krenauer A, Hitzl W, Szeimies U, Stäbler A, Mayer HM (2015): Anterior stand-alone fusion revisited: a prospective clinical X-ray and CT investigation Eur Spine 24:838-851

Indication Statement

INDICATIONS
The SYNFIX Evolution Spacer System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had six months of non-operative treatment.

Additionally, the SYNFIX Evolution Spacer can be used in patients diagnosed with spinal deformities as an adjunct to fusion with DePuy Synthes Spine supplemental internal fixation products (e.g. pedicle screw system) for use in the lumbar spine in addition to integrated screws. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery.

These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

CONTRAINDICATIONS
• Use of the SYNFIX Evolution is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials (PEEK OPTIMA LT-1, Tantalum, Titanium, Aluminum and/or Niobium). 
• Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implant. 
• Conditions that may place excessive stresses on bone and implants, such as severe obesity or degenerative diseases, are relative contraindications. The decision whether to use these devices in patients with such conditions must be made by the physician taking into account the risks versus the benefits to the patient. 
• Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions. These patients may place undue stresses on the implant during bony healing and may be at a higher risk of implant failure. 
• Use of the SYNFIX Evolution is contraindicated when patient anatomy or pathology prevents insertion of all four locking screws.

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