# DEN200039: InSpace Subacromial Tissue Spacer System

- Pathway: De Novo (Direct)
- Applicant: Ortho-Space, Ltd.
- Decided: Jul 12, 2021 after 395 days
- Product code: QPQ (Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable,  Non-Fixed)
- Device class: 2
- Regulation: 21 CFR 888.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
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 a treatment with a shorter surgical time compared to partial rotator cuff repair.

Source page: https://510kreport.com/device/DEN200039
Methodology: https://510kreport.com/methodology