Atlas FDA

QHE

26 FDA 510(k) clearances · Product code

123 daysmedian time to decision
236 days90th percentile
26clearances measured

FDA profile

Official device name
Shoulder Arthroplasty Implantation System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3660
Medical specialty
Orthopedic
FDA definition
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.
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RecordFirmDate
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K260802)Materialise NV2026-06-09
Signature™ ONE System (K261510)Orthosoft Inc. (d/b/a) Zimmer CAS2026-06-04
Signature™ ONE System (K260104)Orthosoft Inc. (d/b/a) Zimmer CAS2026-02-04
Precision AI Surgical Planning System (PAI-SPS) (K251558)Precision AI Pty, Ltd.2026-01-12
Archer PSI System (K243509)3D-Side2025-05-12
CORE Shoulder System (K241470)LinkBio Corp.2025-02-20
Precision AI Surgical Planning System (PAI-SPS) (K243955)Precision AI Pty, Ltd.2025-01-21
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K242813)Materialise NV2024-10-18
Arthrex Virtual Implant Positioning (VIP) System Software (K241097)Arthrex, Inc.2024-10-02
Precision AI Surgical Planning System (PAI-SPS) (K233992)Precision AI Pty, Ltd.2024-08-05
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K241143)Materialise NV2024-05-22
Signature™ ONE System (K232425)Orthosoft Inc. (D/B/A) Zimmer Cas)2023-12-12
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K233408)Materialise NV2023-11-09
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K231112)Materialise NV2023-09-12
Arthrex Virtual Implant Positioning (VIP) System (K230904)Arthrex, Inc.2023-06-22
Arthrex Virtual Implant Positioning (VIP) System (K222007)Arthrex, Inc.2023-03-08
Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner (K230315)Materialise NV2023-03-06
Smart SPACE Shoulder Planner and 3D Positioners (K222405)Lima Corporate S.P.A.2022-12-20
Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner (K220452)Materialise NV2022-08-17
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K212569)Materialise NV2022-01-12
Signature™ ONE System (K212560)Orthosoft Inc (D/B/A Zimmer Cas)2021-10-12
Smart SPACE Shoulder System (K202151)Techmah Medical, LLC2021-02-03
Smart SPACE Shoulder System (K202454)Techmah Medical, LLC2020-12-28
Signature ONE System (K200615)Orthosoft Inc (D/B/A Zimmer Cas)2020-06-05
Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner (K193560)Materialise NV2020-03-20
Signature ONE System (K192074)Orthosoft Inc (D/B/A Zimmer Cas)2019-08-30

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Every clearance here is in the API, with alerts when new ones post.