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510(k) Data Aggregation
(395 days)
The InSpace™ Subacromial Tissue Spacer System is indicated for the treatment of patients with massive. irreparable full-thickness torn rotator cuff tendons due to trauma or degradation with mild to moderate gleno-humeral osteoarthritis in patients greater than or equal to 65 years of age whose clinical conditions would benefit from treatment with a shorter surgical time compared to partial rotator cuff repair.
The InSpace™ Subacromial Tissue Spacer System (Figure 1) is a prescription-use device that is comprised of a biodegradable implant provided pre-loaded on a deployer. The deployer is designed for deployment, inflation, sealing, and detachment of the implant in the subacromial space between the humeral head and the acromion. The system is single-use, supplied sterile, and ready for use in the operating room upon removal from the package. Once positioned in the subacromial space, the implant is filled with sterile saline (0.9%, not provided) to the pre-defined volume, sealed, and released from the deployer. Following implantation, it is designed to biodegrade over approximately one year.
The implant is supplied pre-folded within the cylindrical protective tube of the deployer to facilitate insertion into the subacromial space and achieves its final shape by subsequent unfolding via inflation with sterile saling, and detachment. It is supplied in three sizes to accommodate individual anatomical variations (Small, Medium, or Large). The InSpace implant is designed to reduce pain and restore function to the gleno-humeral joint by acting as a temporary spacer between the humeral head and acromion, enabling smooth gliding between the bones and reducing acromio-humeral contact pressure while depressing the humeral head to a more central anatomical position on the glenoid, similar to that of a shoulder with an intact rotator cuff.
This document describes the InSpace™ Subacromial Tissue Spacer System, a resorbable shoulder spacer intended for patients with massive, irreparable full-thickness torn rotator cuff tendons. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the InSpace™ Subacromial Tissue Spacer System are derived from the primary composite endpoint of the pivotal clinical trial and the special controls outlined.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Clinical Performance (Effectiveness) | Non-inferiority compared to partial repair in improving shoulder function (WORC ≥275 pts, ASES >6.4 pts) and reducing symptoms, with no subsequent secondary surgical interventions (SSSI) or Serious Adverse Device Effects (SADEs) at 24 months, specifically for patients ≥65 years of age. | Achieved (for ≥65 years): |
- For patients ≥65 years: Non-inferiority established (p=0.01) with 87.8% success rate (InSpace™) vs. 88.1% (Partial Repair), within 10% margin.
- WORC improvement (InSpace™): -1083.37 at Month 24, ASES improvement (InSpace™): 46.22 at Month 24. These represent improvements over baseline similar to or numerically greater than Partial Repair.
- Similar SSSI rates for both groups.
- No serious device-related adverse effects observed. | Non-inferiority was not statistically achieved for the overall population (p=0.06) or for patients
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