DeviceClearance

Product code QPQ— Orthopedic

InSpace Subacromial Tissue Spacer System

Classification name
Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
Device class
Class 2
Regulation
21 CFR 888.3630
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QPQ under 21 CFR 888.3630, via openFDA

Market context for product code QPQ

FDA has cleared 1 device under product code QPQ, all in 2021, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QPQ

Recent clearances under product code QPQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.