QHE · Product Code · Chrysalis Intelligence

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Sponsor	Clearances	Last 12 mo	Most recent
Materialise NV	9	1	2026-06-09
Arthrex, Inc.	3	0	2024-10-02
Precision AI Pty, Ltd.	3	1	2026-01-12
Orthosoft Inc. (d/b/a) Zimmer CAS	2	2	2026-06-04
Orthosoft Inc (D/B/A Zimmer Cas)	2	0	2021-10-12
Techmah Medical, LLC	2	0	2021-02-03
Orthosoft Inc. (D/B/A) Zimmer Cas)	1	0	2023-12-12
Lima Corporate S.P.A.	1	0	2022-12-20
LinkBio Corp.	1	0	2025-02-20
3D-Side	1	0	2025-05-12

Code	Type	Description	Confidence	Rationale
23472	CPT	—	High	Arthroplasty, shoulder; standard code for shoulder joint replacement procedure
20985	CPT	—	Medium	Computer-assisted surgical navigational orthopedic procedure; if system provides intraoperative guidance
99070	CPT	—	Low	Supplies and materials provided by the physician; surgical instrument set

Date	K-number	Sponsor	Device
2026-06-09	K260802	Materialise NV	Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
2026-06-04	K261510	Orthosoft Inc. (d/b/a) Zimmer CAS	Signature ONE System
2026-02-04	K260104	Orthosoft Inc. (d/b/a) Zimmer CAS	Signature ONE System
2026-01-12	K251558	Precision AI Pty, Ltd.	Precision AI Surgical Planning System (PAI-SPS)
2025-05-12	K243509	3D-Side	Archer PSI System
2025-02-20	K241470	LinkBio Corp.	CORE Shoulder System
2025-01-21	K243955	Precision AI Pty, Ltd.	Precision AI Surgical Planning System (PAI-SPS)
2024-10-18	K242813	Materialise NV	Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
2024-10-02	K241097	Arthrex, Inc.	Arthrex Virtual Implant Positioning (VIP) System Software
2024-08-05	K233992	Precision AI Pty, Ltd.	Precision AI Surgical Planning System (PAI-SPS)
2024-05-22	K241143	Materialise NV	Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
2023-12-12	K232425	Orthosoft Inc. (D/B/A) Zimmer Cas)	Signature ONE System
2023-11-09	K233408	Materialise NV	Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
2023-09-12	K231112	Materialise NV	Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
2023-06-22	K230904	Arthrex, Inc.	Arthrex Virtual Implant Positioning (VIP) System
2023-03-08	K222007	Arthrex, Inc.	Arthrex Virtual Implant Positioning (VIP) System
2023-03-06	K230315	Materialise NV	Materialise Shoulder System Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
2022-12-20	K222405	Lima Corporate S.P.A.	Smart SPACE Shoulder Planner and 3D Positioners
2022-08-17	K220452	Materialise NV	Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner
2022-01-12	K212569	Materialise NV	Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
2021-10-12	K212560	Orthosoft Inc (D/B/A Zimmer Cas)	Signature ONE System
2021-02-03	K202151	Techmah Medical, LLC	Smart SPACE Shoulder System
2020-12-28	K202454	Techmah Medical, LLC	Smart SPACE Shoulder System
2020-06-05	K200615	Orthosoft Inc (D/B/A Zimmer Cas)	Signature ONE System
2020-03-20	K193560	Materialise NV	Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner

QHE · Unclassified

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