Shoulder Innovations Announces FDA Clearance of New InSet™ Stemless Humeral Implant

Shoulder Innovations Inc., (SI), a leading innovator in the development of shoulder replacement systems, announces the FDA Clearance of their latest component of the InSet™ Total Shoulder System, the InSet™ Stemless Humeral System.

The InSet™Stemless implant is the latest addition to the innovative and integrated InSet™ system, which already includes the successful InSet™ Glenoid, Humeral Short Stem and Reverse components.

The new Stemless device is a component of the first truly integrated shoulder system in the world, combining stemless and stemmed, in both anatomic and reverse configurations in the same platform.

[mks_pullquote align=”right” width=”400″ size=”24″ bg_color=”#1e73be” txt_color=”#ffffff”]Rob Ball, CEO of Shoulder Innovations said, “This most recent product clearance from the FDA is a key component to our multi-product strategy to provide the simplest and most elegant solutions on the market for shoulder surgery.  We have packaged the equivalent of six innovative products in this simple instrumentation set.  We refer to this is as The Power of One, and are proud to bring unmatched efficiency to the market.”[/mks_pullquote]

This platform makes use of the identical instruments and surgical techniques as the existing InSet™ Humeral Short stem, allowing flexibility for intraoperative decision-making with no cost in time or any additional instruments or bone preparation required.

Previously surgeons had to choose—stem or stemless—for each surgical case without the option to easily change from one to the other.  This concise configuration, the first of its kind, is also expected to help reduce O.R. time and reflect savings related to cleaning and sterilization processing costs.

The unique design for the humeral preparation allows for the least amount of bone removal while the implant’s curved fin design maximizes axial and rotational fixation surface area.

Rob Ball, CEO of Shoulder Innovations said, “This most recent product clearance from the FDA is a key component to our multi-product strategy to provide the simplest and most elegant solutions on the market for shoulder surgery.  We have packaged the equivalent of six innovative products in this simple instrumentation set.  We refer to this is as The Power of One, and are proud to bring unmatched efficiency to the market.”

Matt Ahearn, Chief Operations Officer for Shoulder Innovations said, “The addition of the Stemless system expands the clinical options available to our surgeon partners, with the same anatomic surgical technique and no incremental instrumentation. This is extremely exciting for Shoulder Innovations, as we have significant demand from clinicians who want to pair a Stemless implant with our InSet™ Glenoid technology.

David Blue, Chief Commercial Officer at Shoulder Innovations said, “The Stemless implant is another transformational addition to the InSet™ Shoulder System, where we continue to transcend shoulder science.”

The InSet™ Stemless device will be available at select U.S. sites in the coming weeks.

Hot this week

Medtronic Expands AiBLE Spine Surgery Ecosystem with New Technologies and Siemens Healthineers Partnership

New advancements in the AiBLE Spine Surgery ecosystem build upon the company's commitment to procedural innovation and execution

Axlab, Danish Medtech Pioneer, expands to US with Advanced Robotic Tissue Sectioning for Pathology Laboratories

Kris Rokke, National Sales Director for Axlab in the US. "My team and I are extremely excited and honored about this unique opportunity to also offer this advanced technology to labs across the US and thus contribute to the pathology labs of tomorrow."

Spartan Medical Broadens Single-Use Sterile Instrument Portfolio to Improve Outcomes, Increase Efficiency, and Generate Cost Savings

Spartan Medical products portfolio of single-use, sterile med tech includes micro and minor surgical convenience kits, kerrison rongeurs, spinal and general surgical retractors, dural repair kits, synthetic biologics, and a wide range of orthopedic pre-sterilized implants and devices.

Recor Medical Supports European Society of Cardiology’s Hypertension Guidelines

Record Medical notes the new guidelines, "2024 ESC Guidelines for the management of elevated blood pressure and hypertension," have been published online and recommend the consideration of renal denervation (RDN) as a safe and effective treatment option for patients who have uncontrolled resistant hypertension or those that have uncontrolled hypertension with a higher risk of cardiovascular disease, who express a preference to undergo RDN.

ConTIPI Medical Selects EVERSANA to Support U.S. Commercialization of Non-Surgical Medical Device ProVate for Women with Pelvic Organ Prolapse

EVERSANA is a leading provider of global commercial services to the life sciences industry, to support commercialization for the ProVate device in the United States to help women experiencing pelvic organ prolapse.