← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
DEVICE CLASS
Class II
REGULATION
21 CFR 888.3390
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES
Recent clearances
K253357B-One Ortho, Corp. · 510k2026-04-13
K243634Maxx Orthopedics, Inc. · 510k2025-08-25
Related on SPEQ
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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