Holland, Michigan-based Shoulder Innovations, LLC has announced that the FDA granted the company a 510(k) clearance for its InSet Humeral Short Stem System for shoulder arthroplasty. The system was cleared on October 23, 2018, after an almost 10-month review by the agency.
FDA Clears Shoulder Innovations’ Humeral Short Stem System
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Indications Use/Indications
According to FDA documents, “The…system is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following:
- Significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
- Avascular necrosis of the humeral head.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty.”
“…components of the system are intended for single use only. The glenoid component is intended for cemented fixation only; the humeral stem may be implanted by press-fit or cement fixation.”
InSet System
The system consists of modular humeral stems and heads and articulates with the company’s glenoid component. “The humeral stems are collarless and manufactured from Titanium Alloy (Ti6-4) with fins to provide rotational stability.”
Collarless Stems
“The collarless stems,” says the company, “allow the humeral head to prevent stem subsidence and have a female Morse-type taper to interface with the modular humeral heads.”
“The proximal body and fins are coated with a rough, porous coating for un-cemented fixation or for use with bone cement.”
Humeral Heads
“The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.”
Peter Johnston, M.D. of Southern Maryland Orthopaedic and Sports Medicine said the system is a game-changer. He said the strengths of the InSet are its, “streamlined instrumentation, proprietary coating technology for implant fixation with bone preservation and ability to reproduce native humeral anatomy.”
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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