Chrysalis Intelligence · Product Codes · QHE

QHE · Shoulder Arthroplasty Implantation System

Orthopedic · 25 clearances · 10 unique sponsors

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Device class
Class II
Regulation 888.3660
Total clearances
25
2020-03-20 → 2026-06-09
Last 12 months
4
Unique sponsors
10
Definition

What is Shoulder Arthroplasty Implantation System

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.
Classification details
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3660
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

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

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
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
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
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
Data source: openFDA · Generated 2026-10-07 10:52 · Last ingest 2026-10-07T14:52:06.530357 · Pipeline: Chrysalis Intelligence