← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
DEVICE CLASS
Class II
REGULATION
21 CFR 888.3358
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
21
510(K)/PMA CLEARANCES
510k: 21
0
RECALL ENTRIES
Recent clearances
K261624Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 510k2026-07-10
K243192Nextstep Arthopedix, LLC · 510k2026-06-05
K251270Biomet, Inc. · 510k2026-05-19
K252623Zimmer, Inc. · 510k2026-02-04
K251043Medacta International S.A. · 510k2026-01-28
K252067Restor3D, Inc. · 510k2025-12-05
K252846Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 510k2025-11-20
K251833Encore Medical L.P. · 510k2025-11-12
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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