QPQClass IIImplant
Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-fixed
Orthopedic · 21 CFR 888.3630
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.
MDR events54All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances1All time
Recent MDR events
54 adverse event reports on file
- INSPACE IMPLANT - SMALLJul 9, 2026InjuryOrthospace Ltd.3016573902-2026-00007
- INSPACE US MEDIUMJul 7, 2026InjuryOrthospace Ltd.3016573902-2026-00006
- INSPACE US MEDIUMJun 23, 2026InjuryOrthospace Ltd.3016573902-2026-00005
- STRYKER INSPACE SUBACROMIAL BALLOONJun 22, 2026MalfunctionOrtho-space Ltd./stryker Corp.MW5189723
- INSPACE IMPLANT - LARGEJun 4, 2026MalfunctionOrthospace Ltd.3016573902-2026-00003
- INSPACE IMPLANT - MEDIUMJun 4, 2026MalfunctionOrthospace Ltd.3016573902-2026-00004
- INSPACE US LARGEJan 27, 2026MalfunctionOrthospace Ltd.3016573902-2026-00002
- INSPACE US LARGEJan 16, 2026InjuryOrthospace Ltd.3016573902-2026-00001
- INSPACE IMPLANT - LARGEDec 30, 2025InjuryOrthospace Ltd.3016573902-2025-00006
- INSPACE US MEDIUMNov 10, 2025MalfunctionStryker Endoscopy-san Jose3016573902-2025-00005
Event type breakdown
Injury44
Malfunction10
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
1 clearances for this product code