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When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the U.L.I.S. ™ and LUMIS™ systems are indicated for:

· degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

• · spondylolisthesis
• fracture
• · spinal stenosis
• · tumors
• · failed previous fusion (pseudoarthrosis)

The U.L.I.S. ™ and LUMIS™ systems are pedicie screw systems indicated for skeletally mature patients who:

• · have severe spondvlolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
• · receive fusions using autogenous bone graft only;
• have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
  • · have the device removed after the development of a solid fusion.

In addition, the U.L.I.S.™ and LUMIS™ systems are pedicle screw systems intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T10-S1):

• degenerative spondylolisthesis with objective evidence of neurologic

• impairment
  • fracture
  • spinal tumor
  • · failed previous fusion (pseudoarthrosis)

The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ Description System), and Lumbar Universal Minimally Invasive System (LUMIS™ System) instrumentations are composed of cannulated (LUMIS™) and non-cannulated (U.L.I.S.™) pedicle screws and fixation rods (SpineVision UNI-Thread™ rods or LUMIS™ percutaneous rods). Their components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient and are supplied nonsterile. These constructs are assembled using specific instruments. The components of the U.L.I.S.™ and LUMIS™ systems are made of Titanium Ti-6Al-4V ELI complying with ASTM F136 (ISO 5832-3). The components added within this submission include: New reference of LUMIS™ rods (Straight and pre-bent), 12 new instruments for LUMIS™ system, 4 new instruments for U.L.I.S.™ system. The devices provide correction and rigid cannulated. stabilization of the spine during development of solid bone fusion following corrective spine surgery for a number of indications (listed above).

The provided text describes a 510(k) submission for a medical device, the SpineVision U.L.I.S.™ and LUMIS™ Pedicle Screw Fixation Systems. This is a submission for an extension of range of products to a previously cleared device (K112607).

The key takeaway is that no new clinical or additional testing was performed, nor was a new study conducted to prove the device meets acceptance criteria. Instead, SpineVision S.A. claims substantial equivalence to their predicate device based on engineering analysis and design validation/verification.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth cannot be extracted as it is not present in the provided document. The 510(k) summary explicitly states:

• "No additional testing has been performed for the added components."
• "No clinical data has been presented."

The submission relies on the previously established performance of the predicate device (K112607) and asserts that the new components do not alter the fundamental safety and effectiveness.

Given this, I cannot fill out the requested table or paragraphs accurately, as the document explicitly states the absence of such new data.

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