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BioWorld - Sunday, January 18, 2026
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Home » FDA greenlights Stryker’s balloon implant for shoulder repairs
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FDA greenlights Stryker’s balloon implant for shoulder repairs

July 16, 2021
By Meg Bryant
Stryker Corp. has won the FDA’s nod for an implantable balloon spacer to aid in the healing of torn rotator cuffs. The de novo clearance of the Inspace subacromial tissue spacer system comes more than a decade after the biodegradable shoulder repair implant first debuted in European markets. The minimally invasive Inspace device is intended for arthroscopy treatment of massive irreparable rotator cuff tears (MIRCTs).
BioWorld MedTech Regulatory Orthopedics 510(k) FDA

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