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The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograff or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation)
4. Spinal Stenosis.
5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor.
7. Pseudoarthrosis, and
8. Failed previous fusion

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This submission includes modified polyaxial screws, additional multiaxial-cross-connectors, offset connectors and additional components in sterile version. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system are shaped intraoperatively to correct or maintain proper spinal curvature.

This document is a 510(k) premarket notification for a medical device (ENNOVATE® Spinal System) and as such, it describes the equivalence of the device to existing predicate devices, rather than establishing acceptance criteria and proving the device meets them through a performance study against a defined ground truth.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert consensus, adjudication methods, MRMC studies, and standalone algorithm performance, is not present in this document.

The document focuses on demonstrating substantial equivalence through:

• Indications for Use: Listing the conditions the device is intended to treat, which are the same as the predicate devices.
• Technological Characteristics: Stating that the components, materials (titanium alloy, medical grade silicone, stainless steel, titanium alloy, PEEK), and configurations are similar to predicate and reference devices.
• Performance Data: Citing various ASTM standards (F1717-15, F2193-14, F1798-13, F543-13/17) for mechanical testing (dynamic/static compression, torsion, flexion bending, pull-out strength, driving torque). These tests confirm the physical properties and mechanical performance are comparable to the predicate, not that the device meets clinical acceptance criteria.

In summary, this document does not contain the information required to populate the requested table or answer the specific questions about clinical performance studies, AI algorithms, or human-in-the-loop improvements, because it is a 510(k) submission focused on substantial equivalence, not a clinical trial report proving a device meets specific clinical performance acceptance criteria.

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