Medical Device Review: Solana Surgical TenFUSE™ PIP

TenFUSE-x-ray
Solana Surgical TenFuse

It has recently become a staple (no pun intended) for medical device companies to develop and offer their own version of a hammertoe implant. New hammertoe products have been discussed in previous blog posts and product reviews, including the Trilliant Surgical Two-Step Hammertoe Implant and our most recent product review by Dr. Luke D. Cicchinelli on the Arthrex Trim-It Drill Pin™. This brings us to our March medical device review on yet another hammertoe implant, the Solana Surgical TenFUSE PIP. Diverging from the typical implant make-up, Solana has gone in a completely different direction than its competitors and devised a series of new implants based on resorbable bone. Per the product description: “The TenFUSE™ PIP is a sterile allograft that is partially demineralized to maintain inductive and conductive properties.”

Solana Surgical TenFUSE Packaging
TenFUSE PIP Product Packaging

This follows suit with the current market trend in that buried implants have taken favor over traditional external k-wire fixation. The obvious advantage of this new hammertoe implant is the “natural” incorporation of the graft into the surrounding bone. This allows the exclusive benefit of avoiding the potential for long-term hardware failure or other hardware related complications. In contrast to metallic implants, we hypothesize that the graft implant may not be able to withstand the same amount of stress initially and thus has the short-term potential of breaking. This is something that may be prevented with protective weight-bearing and good patient compliance.

Our first experience with implanting the TenFUSE was very favorable and our take home impression of the experience included the following: Fast, Stable and Natural. The step-wise process was rather quick once the digit was ready for implant insertion as there is minimal handling needed. The proximal phalanx is pre-drilled (using the included 2.0mm or 2.7mm drill bit) to the second of two laser etched lines; the middle phalanx is then pre-drilled to the first laser line only. The implant is now ready for placement.

Pre-drill The Phalanx for Graft Implementation
Pre-drill For Graft Implementation

SurgicalFixation Tip: When overdrilling the phalanges, clear all excess bone from the canal to prevent debri impaction and difficulty with graft insertion.

Similar to other hammertoe implants, the graft is secured with a hemostat and inserted into the proximal and middle phalanx by closing the arthrodesis site down with the distal toe. While inserting the graft, you will notice small groves/ridges within the graft itself that will, by design, snap into place as the graft is positioned deeper into the phalanx. The added benefit of using this graft is that if a gap remains between the osseous ends of the fusion site, a rongeur or bone cutting forceps can be used to shorten the graft to the appropriate length. Additionally, if the graft breaks from forceful surgeon handling, the insertion canal can be re-drilled and the graft can be taken down if needed; something uncharacteristic of most metallic hmmertoe implants.

Caution: The Graft is fragile and can be easily broken if not inserted correctly or under too much force. Minimize angled manipulation of the graft and you will be pleased with your results!

Solona Surgical TenFUse PIP
TenFUSE Graft Insertion

The Implant is available in straight & 10° angled configurations, while the octagonal shape and ridges help resist rotation. Additional features of the graft include tapering on the proximal end to promote ease of insertion and DEPTH STOP to help accurately position the implant. The graft is partially demineralized to maintain inductive and conductive properties.

Bottom Line: The new Solana Surgical TenFUSE PIP hammertoe implant is the latest medical device devised specifically for buried stabilization. Like all implants, there are benefits that are appealing to both the surgeon and patient. The ease of implantation and natural incorporation into the surrounding bone are the positives that separate this implant from its competitors. The TenFUSE PIP will offer you a new angle on hammertoe repair, especially for those who favor non-metallic implants, including your patients! SurgicalFixation Recommended!!!.

All Solana Surgical products are viewable here.

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The Unbiased Authority: There are no conflicts of interest or financial association / assistance between SurgicalFixation and Solana Surgical. 

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