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510(k) Data Aggregation
K Number
K171151Device Name
ACRON TLIF System
Manufacturer
Date Cleared
2018-04-27
(372 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
SpineMED Ges.m.b.H
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ACRON™ TLIF System is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. The ACRON™ TLIF System is to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Device Description
The ACRON™ TLIF System is an implant system for a unilateral posterior transforaminal approach (TLIF). It is specially designed for small incision (minimally invasive), resulting in a relatively atraumatic operation for the patient. Implants, used with supplemental fixation and autogenous bone graft, provide improved stability, height restoration and lordosis to optimize fusion. The system is comprised of implantable cages and stainless steel surgical instruments, both general and system specific.
The ACRON™ TLIF System cages are manufactured from radiolucent polymer PEEK-OPTIMA® Optima LT1 (Polyether-ether-ketone) conforming to ASTM standard F2026, to allow for clear assessment of bone fusion. Two radiopaque markers constructed from Tantalum conforming to ASTM standard F560 allow for radiographic visualization of the implant orientation and placement.
The implants have a convex shape and are offered in 4 sizes, in 2mm increments, ranging in height from 7mm to 13mm with lordotic angle of 8°, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Teeth on the superior and inferior surfaces help the implant to resist expulsion and migration. The geometry includes openings to allow for the packing of autogenous bone graft into the axial canal.
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