← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained

Replacement of the humeral head for total anatomic shoulder arthroplasty

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3660
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K254154FX Shoulder Solutions, Inc. · 510k2026-05-01
K252129Smith & Nephew, Inc. · 510k2025-10-03
K243248Depuy Ireland UC · 510k2024-12-23
K241873Zimmer, Inc. · 510k2024-12-11
K240716Smith & Nephew, Inc. · 510k2024-11-20

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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