Not Cleared Direct

DEN200039 - InSpace Subacromial Tissue Spacer System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200039 · Ortho-Space , Ltd. · Orthopedic device
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Jul 2021
Decision
395d
Days
Class 2
Risk

DEN200039 is an FDA 510(k) submission (not cleared) for the InSpace Subacromial Tissue Spacer System. Classified as Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-fixed (product code QPQ), Class II - Special Controls.

Submitted by Ortho-Space , Ltd. (Caesarea, IL). The FDA issued a Not Cleared (DENG) decision on July 12, 2021 after a review of 395 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3630 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 395 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Ortho-Space , Ltd. devices

Submission Details

510(k) Number DEN200039 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 12, 2020
Decision Date July 12, 2021
Days to Decision 395 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
273d slower than avg
Panel avg: 122d · This submission: 395d
Pathway characteristics

Device Classification

Product Code QPQ Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-fixed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3630
Definition A Resorbable Shoulder Spacer Is Intended To Act As A Temporary Spacer, Creating A Physical Barrier Between Tissues In The Shoulder, For The Treatment Of Massive Irreparable Rotator Cuff Tears.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.