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) partialthickness tear of supraspinatus or supraspinatus with infraspinatus.

• Subject has failed a minimum of 3 months of conservative management for treatment ofpartial 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 studyquestionnaires.

Exclusion Criteria:

• Subjects with insufficient tendon tissue quality for management and protection ofthe tendon injury using the isolated REGENETEN Bioinductive Implant system.

• Subjects where the prescribed Physical Therapy guidelines stated in the protocol arenot 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 subacromialdecompression, biceps tenodesis/tenotomy, and acromioclavicular joint (ACJ)excision/distal clavicle excision (DCE).

• Subjects with a planned surgery on the contra-lateral shoulder within the studyperiod.

• Systemic steroid use (oral, IV) or local steroid injection within 3 months of thedate of surgery.

• Subjects with a full thickness rotator cuff tear.

• Subjects with a subscapularis tear requiring repair.

• Subjects requiring a concomitant labral fixation procedure, concomitant surgery forbone defects requiring bone implantation or for superior labral tear from anteriorto posterior (SLAP).

• Subjects requiring a concomitant os acromiale fixation procedure.

• Subjects with glenohumeral joint instability (multiple dislocations/subluxations).

• Subjects with condition(s) that contraindicate or complicate outcomes of IsolatedBioinductive Repair or completion and repair e.g., > Hamada 3 rotator cuffarthropathy on X-ray, Goutallier atrophy > Grade 3, proximal humeral fracture orscapular fracture, avascular necrosis of the humeral head.

• Subjects with neurologic conditions effecting either upper extremity.

• Subjects who are unable to tolerate magnetic resonance imaging (MRI), due topsychiatric or medical contraindications.

• Subjects who are pregnant or breast feeding.

• Subjects who are currently involved in any injury litigation relating to the indexshoulder.

• Subjects with current workers compensation claim.

• Subjects who are enrolled, or plan to enroll, in another clinical trial during thisstudy that would affect the outcomes of this study.

• Subjects with a history of poor compliance with medical treatment, physical therapy (PT)/rehabilitation, or clinical study participation.

• Subject who, in the opinion of the Investigator, has an emotional or neurologicalcondition that would pre-empt their ability or willingness to participate in thestudy including mental illness, mental retardation, and drug or alcohol abuse.

• Subjects who do not meet the indication or are contraindicated according to specificSmith+Nephew REGENETEN System's Instructions for Use (IFUs).

• Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.55.

• Subjects who have participated previously in this clinical trial and who have healedor been withdrawn

• Subjects with a medical or physical condition that, in the opinion of theInvestigator, would preclude safe subject participation in the study.