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FDA PRODUCT CODE · CLASS II

QHE — 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.

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3660
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES

Recent clearances

K260802Materialise NV · 510k2026-06-09
K261510Orthosoft Inc. (d/b/a) Zimmer CAS · 510k2026-06-04
K260104Orthosoft Inc. (d/b/a) Zimmer CAS · 510k2026-02-04
K251558Precision AI Pty, Ltd. · 510k2026-01-12
K2435093D-Side · 510k2025-05-12
K241470LinkBio Corp. · 510k2025-02-20
K243955Precision AI Pty, Ltd. · 510k2025-01-21
K242813Materialise NV · 510k2024-10-18

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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