(86 days)
The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at the fifth humbar - first sacral vertebral (L5-S1) joint utilizing autologous bone graft, having the device fixed or attached to the lumbar and sacral spine and intended to be removed after solid firsion is attained.
Benefit of spinal fusions utilizing any pedicle screw fixation has not been adequately established in patients with stable spines.
Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visoeral injury.
The ISOLA Soinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to The non-pedicle screw indications are ilium/sacrum. the spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery.
As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.
The two piece Twister connector design utilizes the attributes of the one piece slotted connectors. It consists of a slotted transverse member with splines which mate with the splines of the V Groove body. Together these two pieces create the slotted connector assembly. The spline connection or joint is the medium by which the screw/connector interface can be manipulated and secured. This two piece design allows for intraoperative sagittal alignment in 7° increments. The slotted portion of each design provides further surgical latitude for placement of the screw. The machine threaded portion of the screw is locked to the connector with a nut.
This document describes a 510(k) summary for the ISOLA System ISOLA Twister Connector (Titanium) and does not contain information about acceptance criteria or a study proving that a device meets such criteria. Specifically, it is lacking all the requested information for the acceptance criteria and performance study.
The document focuses on the description, material, indications, and substantial equivalence of the device. It includes a brief statement under "PERFORMANCE DATA" that "Static and fatigue testing shows the constructs of the ISOLA Twister Connector to perform consistently with previously cleared components." However, this is a general statement and does not provide acceptance criteria or the detailed study requested in the prompt.
Therefore, I cannot populate the table or provide any of the other requested details based on the provided text.
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K965046 ۱۰۶۵
MAR 1 4 1997
ISOLA SYSTEM ISOLA Twister Connector (Titanium) 510(k) SUMMARY
COMPANY: AcroMed Corporation 3303 Carnegie Avenue Cleveland, OH 44115 TRADENAME: ISOLA Twister Connector used with the ISOLA System Labeled for pedicle screw use: CLASSIFICATION: Spondylolisthesis spinal fixation device system; Unclassified, preamendments device system Labeled for previously cleared uses: Spinal interlaminal fixation orthosis; Class II DESCRIPTION: The two piece Twister connector design utilizes the attributes of the one piece slotted connectors. It consists of a slotted transverse member with splines which mate with the splines of the V Groove body. Together these two pieces create the slotted connector assembly. The spline connection or joint is the medium by which the screw/connector interface can be manipulated and secured. This two piece design allows for intraoperative sagittal alignment in 7° increments. The slotted portion of each design provides further surgical latitude for placement of the screw. The machine threaded portion of the screw is locked to the connector with a nut. MATERIAL: All implant components are manufactured of ASTM F 136 titanium alloy.
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INDICATIONS:
The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at the fifth humbar - first sacral vertebral (L5-S1) joint utilizing autologous bone graft, having the device fixed or attached to the lumbar and sacral spine and intended to be removed after solid firsion is attained.
Benefit of spinal fusions utilizing any pedicle screw fixation has not been adequately established in patients with stable spines.
Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visoeral injury.
The ISOLA Soinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to The non-pedicle screw indications are ilium/sacrum. the spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery.
As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.
PERFORMANCE DATA:
Static and fatigue testing shows the constructs of the ISOLA. Twister consistently with Connector to perform previously cleared components.
SUBSTANTIAL EQUIVALENCE:
The ISOLA Twister Connector manufactured from thanium alloy is equivalent to the ISOLA Twister Connector manufactured from implant grade stainless steel and other AcroMed Slotted Connectors in intended use and attachment.
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