QPQ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Device class

Class II (moderate risk)

Regulation

21 CFR 888.3630

Medical specialty

Orthopedic

Flags

Implant

FDA 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.

Adverse events (MAUDE)

2023: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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