Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

Inclusion Criteria: * The subject must provide written informed consent. * Subject is \> eighteen (18) years of age (no upper limit). * Subject has an isolated high-grade (\>50% or \>6mm) (Ellman grade III) partial thickness tear of supraspinatus or supraspinatus with infraspinatus. * Subject has failed a minimum of 3 months of conservative management for treatment of partial thickness rotator cuff tear. * Subject willing and able to make all required study visits. * Subject able to follow instructions and deemed capable of completing all study questionnaires. Exclusion Criteria: * Subjects with insufficient tendon tissue quality for management and protection of the tendon injury using the isolated REGENETEN Bioinductive Implant system. * Subjects where the prescribed Physical Therapy guidelines stated in the protocol are not suitable for their rehabilitation. * Subjects with Samilson-Prieto osteoarthritis grade 2 and greater. * Subjects with current or prior infection of the ipsilateral shoulder. * Subjects with known hypersensitivity to bovine-derived materials. * Subjects with known inflammatory arthropathy, history of inflammatory arthropathy, chronic joint disease or chronic pain of upper extremities (shoulder(s), arm(s)). * Subjects with prior shoulder surgery on index shoulder, including subacromial decompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ) excision/distal clavicle excision (DCE). * Subjects with a planned surgery on the contra-late…