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Shoulder Arthroplasty Implantation System
FDA product code QHE · Class 2 · Orthopedic
126
Registered devices
8
Adverse events
2
Recalls
26
510(k) clearances
Devices with this code
Signature ONE — Orthosoft IncAtlasPlan — Materialise NVComprehensive® Total Shoulder Guide and Bone Model Right — Orthosoft IncCORE Shoulder System — Link Bio CorpAtlasPlan — Materialise NVSmart SPACE SHOULDER — LIMACORPORATE SPASignature™ Comprehensive® — Orthosoft IncTMR+™ Shoulder Guide and Bone Model Left — Orthosoft IncSignature ONE — Orthosoft IncBlueprint — TORNIERSmart SPACE SHOULDER — LIMACORPORATE SPAArthrex® — ARTHREX, INC.Smart SPACE SHOULDER — LIMACORPORATE SPACORE Shoulder System — Link Bio CorpLima PSI — Materialise NVSmart SPACE SHOULDER — LIMACORPORATE SPAMatch Point System — Materialise NVArthrex® — ARTHREX, INC.Match Point System — Materialise NVArthrex® — ARTHREX, INC.Arthrex® — ARTHREX, INC.MyShoulder Planner — Medacta International SATruMatch Personalised Solutions Shoulder System — Materialise NVSmart SPACE SHOULDER — LIMACORPORATE SPA
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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