Wenzel Spine’s panaSIa Sacroiliac Fusion Implant Gets FDA Clearance

Wenzel Spine has secured FDA 510(k) clearance for panaSIa, marking the first-ever expandable sacroiliac (SI) fusion implant approved in the US.

Designed for minimally invasive dorsal placement, the panaSIa system features an expandable architecture that allows surgeons to pierce both the ilium and sacrum, deploy bone graft post-expansion and maintain fixation — all without removing the instrumentation.

The launch follows over 17 years of the company’s expertise in expandable implant design, according to Wenzel, and represents the next generation of SI fusion solutions.

SI joint fusion is a surgical procedure designed to treat chronic pain in the SI joint, which connects the sacrum (the triangular bone at the bottom of the spine) to the ilium (part of the pelvis). This joint is essential for transferring weight and forces between the upper body and the legs, but can become a source of significant lower back or buttock pain due to dysfunction, inflammation or degeneration.

The goal of SI joint fusion is to stabilize the joint and eliminate abnormal motion by permanently joining the bones together using medical implants, bone grafts or a combination of both. The procedure is typically recommended for patients who have not found relief from non-surgical treatments such as physical therapy, medications or joint injections.

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“We are excited to bring this transformative innovation to market,” said William Wilson, CEO of Wenzel Spine, in a press release. “FDA clearance for the panaSIa SI Fusion System reflects our continued commitment to improving patient outcomes through advanced, expandable technologies that meet the evolving needs of both surgeons and their patients.”

In the press release, neurosurgeon Dr. Charley Gordon explained that by distracting the joint and minimizing micromotion, panaSIa delivers immediate stability, arthritic pain relief and prepares the joint for successful fusion.

Wenzel Spine said the system will be available first through a limited commercial release, with full-scale commercialization planned for Q4 2025.

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In 2023, Wenzel received FDA clearance to expand the clinical indications of its primaLOK SP minimally invasive spinal fusion system, enabling its use at multiple spinal levels, including for patients with lumbar spinal stenosis.

In early 2023, the company launched VariLift‑C, the US’s only zero‑profile, stand-alone expandable cervical interbody fusion device cleared by the FDA. This innovation enables surgeons to perform anterior cervical discectomy and fusion (ACDF) procedures without the need for supplemental hardware, such as plates or screws.

In 2023, the global SI fusion market was valued at approximately $294 million, with projections suggesting it could reach nearly $985 million by 2030 at a compound annual growth rate (CAGR) of around 19%.

The overall spinal fusion devices market, which includes lumbar, cervical, thoracic and SI fusion systems, was valued at $9.9 billion in 2023 and is projected to reach $16.6 billion by 2033, with minimally invasive technologies driving much of the innovation and revenue growth.