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The Innovasis PEEK IBF System (Px, Px HA and TxHA) is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine. Px® and Px HA® devices are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach. TxHA™ devices are placed via a transforaminal (TLIF) approach.

This device is intended to be used with internal spinal fixation systems such as the Imovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.

The Innovasis TxHA PEEK IBF Spinal System is a line extension of the Px Posterior Spinal IBF System, an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The Px IBF was submitted to FDA under K150500 in February 2015, and was cleared for sale in the USA on June 19, 2015. The Px HA design manufactured using Invibio® PEEK-Optima® HA Enhanced was cleared under K151785 on October 14, 2015. In this material, hydroxyapatite (HA), is integrated with Invibio's PEEK-OPTIMA Natural.

The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone through-growth, with anti-migration teeth to engage the vertebral endplates and prevent expulsion. The implants have a slightly convex profile and are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support PLIF/TLIF surgeries are provided with the implants in sterilization trays.

The Px implants are machined from medical grade Solvay Zeniva ZA-500 or Evonik VESTAKEEP i4R PEEK. The Px HA and TxHA implants are machined from Invibio® PEEK-OPTIMA® HA Enhanced* polyetheretherketone with hydroxyapatite. The radiographic markers meet ASTM F560 for unalloyed Tantalum. HA is a naturally occurring mineral in bone and is widely used in the orthopedic field.

The provided text is a 510(k) Premarket Notification from the FDA regarding an intervertebral body fusion device. It primarily discusses the device's substantial equivalence to previously cleared predicate devices based on non-clinical performance testing.

It does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of clinical performance or algorithm-based performance. The document focuses on regulatory approval based on mechanical and material equivalence to existing devices.

Therefore, I cannot provide the requested information from the given text.

If this were a document about an AI/ML medical device, the information I'd look for to answer your questions would typically be in sections detailing clinical studies, algorithm validation, or performance evaluation.

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