Shoulder Arthroplasty Implantation System
Orthopedic · 21 CFR 888.3660
Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
Recent MDR events
8 adverse event reports on file
- ARTHREXVIP WEB PORTALJul 7, 2026MalfunctionArthrex, Inc.1220246-2026-03626
- CORE SHOULDER SYSTEMMar 6, 2026MalfunctionLinkbio Corp.3006721341-2026-00004
- BLUEPRINT SOFTWAREJan 15, 2025MalfunctionWright Medical Technology Inc3000931034-2025-00037
- BLUEPRINT SOFTWAREApr 8, 2024MalfunctionTornier S.a.s.3000931034-2024-00196
- BLUEPRINT SOFTWAREApr 8, 2024MalfunctionTornier S.a.s.3000931034-2024-00198
- BLUEPRINT SOFTWAREApr 8, 2024MalfunctionTornier S.a.s.3000931034-2024-00197
- BLUEPRINT SOFTWAREApr 8, 2024MalfunctionTornier S.a.s.3000931034-2024-00195
- BLUEPRINT SOFTWAREApr 8, 2024MalfunctionTornier S.a.s.3000931034-2024-00199
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Linkbio Corp.Open, ClassifiedApr 10, 2026
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
Z-1810-2026 · View FDA record ↗ - Tornier S.A.S.Open, ClassifiedUnknown
The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only:
Potential patient exposure to the graphite substrate.
Z-2291-2021 · View FDA record ↗
Registered firms
93 firms currently registered for this product code
Tracer Orthopedics
Oakland, NJ, US
Tornier Inc.
Columbia City, IN, US
Materialise N.v.
LEUVEN Vlaams Brabant, BE
Medacta International Sa
Rancate Ticino, CH
Arthrex, Inc.
Ave Maria, FL, US
Materialise Ukraine, Rep. Office
Kyiv Kyyiv, Misto, UA
Imascap
PLOUZANE Finistere, FR
Zimmer Cas
MONTREAL, QUEBEC, CA
Arthrex Gmbh
Munich Bavaria, DE
Precision Ai Pty Ltd
Brisbane Queensland, AU
Tornier S.a.s
Montbonnot Saint-Martin Isere, FR
I-medical Asia Company Limited
Kowloon Bay, HK
Materialise Usa, Llc.
Plymouth, MI, US
Arthrex, Inc.
Naples, FL, US
510(k) clearances
26 clearances for this product code
- Materialise NVJun 9, 2026
K260802 · Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- Orthosoft Inc. (d/b/a) Zimmer CASJun 4, 2026
K261510 · Signature ONE System
- Orthosoft Inc. (d/b/a) Zimmer CASFeb 4, 2026
K260104 · Signature ONE System
- Precision AI Pty, Ltd.Jan 12, 2026
K251558 · Precision AI Surgical Planning System (PAI-SPS)
- 3D-SideMay 12, 2025
K243509 · Archer PSI System
- LinkBio Corp.Feb 20, 2025
K241470 · CORE Shoulder System
- Precision AI Pty, Ltd.Jan 21, 2025
K243955 · Precision AI Surgical Planning System (PAI-SPS)
- Materialise NVOct 18, 2024
K242813 · Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner