InSpace Subacromial Tissue Spacer System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- DEN200039 FDA 510(k)
- FDA Product Code
- QPQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3630 FDA 510(k)
- Regulation Number
- 888.3630 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The InSpace Subacromial Tissue Spacer System is a resorbable, inflatable shoulder spacer designed for use in patients with massive irreparable rotator cuff tears. Classified as a Shoulder Spacer under FDA nomenclature, it is intended to restore subacromial space and reduce impingement symptoms by providing temporary structural support.
This system is supplied as a single-use, non-fixed device and is regulated under FDA 510(k) clearance (K-number: DEN200039) and EU MDR. It is intended for orthopedic use, with specific FEI numbers (3016573902, 2936485, 3002807555) and registration numbers (3016573902, 3008729892, 2936485) under regulation 888.3630. Storage and handling must comply with sterile medical device protocols.
Frequently asked questions
What is the primary purpose of the InSpace Subacromial Tissue Spacer System in clinical practice?
The InSpace Subacromial Tissue Spacer System is designed to restore subacromial space and alleviate impingement symptoms in patients with massive irreparable rotator cuff tears. By providing temporary structural support, it helps maintain shoulder function while the tissue heals or adapts.
Is the InSpace Subacromial Tissue Spacer System reusable or intended for single-use?
The InSpace Subacromial Tissue Spacer System is explicitly labeled as a single-use device. This classification ensures patient safety and sterility, as it is not intended for reuse or reprocessing.
How should the InSpace Subacromial Tissue Spacer System be stored to maintain its integrity?
Since it is a sterile medical device, the InSpace Subacromial Tissue Spacer System must be stored and handled according to standard sterile medical device protocols. This includes keeping it in its original packaging until immediate use and avoiding contamination or exposure to conditions that could compromise sterility.
What regulatory pathways does the InSpace Subacromial Tissue Spacer System follow in the U.S. and EU?
In the U.S., the device has received FDA 510(k) clearance under K-number DEN200039, classified as a Shoulder Spacer for massive irreparable rotator cuff tears. In the EU, it complies with MDR (Medical Device Regulation). Both pathways ensure it meets stringent safety and performance standards before market authorization.
What materials is the InSpace Subacromial Tissue Spacer System made from, and how does this affect its use?
The device is described as resorbable, meaning it is designed to gradually break down and be absorbed by the body over time. This feature eliminates the need for a second surgery to remove the spacer, making it a temporary solution for restoring shoulder function while the underlying tissue adapts.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | DEN200039 | Class II | Active |
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Manufacturer
- Manufacturer
- Ortho-Space Ltd
- FDA Applicant
- Ortho-Space , Ltd.
Sources (2)
- FDA 510(k) DEN200039 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026