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Shoulder Arthroplasty Implantation System
FDA product code QHE · Class 2 · Orthopedic
134
Registered devices
8
Adverse events
2
Recalls
26
510(k) clearances
Devices with this code
Arthrex® — ARTHREX, INC.Veritas Reverse Total Shoulder — Restor3d, Inc.Blueprint — TORNIERTMR+™ Shoulder Guide and Bone Model Right — Orthosoft IncShoulder Bone Model Only 3.2mm Pin — Orthosoft IncBlueprint — TORNIERArthrex® — ARTHREX, INC.Lima PSI — Materialise NVTruMatch Personalised Solutions Shoulder System — Materialise NVComprehensive® Total Shoulder Guide and Bone Model Left — Orthosoft IncCORE Shoulder System — Link Bio CorpTruMatch Personalised Solutions Shoulder System — Materialise NVSmart SPACE SHOULDER — LIMACORPORATE SPABlueprint — TORNIERSmart SPACE SHOULDER — LIMACORPORATE SPABlueprint — TORNIERArthrex® — ARTHREX, INC.Smart SPACE SHOULDER — LIMACORPORATE SPATruMatch Personalised Solutions Shoulder System — Materialise NVComprehensive® Reverse Shoulder Mini Guide and Bone Model Left — Orthosoft IncSignature ONE Software Package — Orthosoft IncArthrex® — ARTHREX, INC.TrueSight — Materialise NVVeritas Reverse Total Shoulder — Restor3d, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-12 | Linkbio Corp. | The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen. |
| 2021-06-25 | Tornier S.A.S. | Potential patient exposure to the graphite substrate. |
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