← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3565
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
18
510(K)/PMA CLEARANCES
510k: 18
0
RECALL ENTRIES

Recent clearances

K251840Zimmer, Inc. · 510k2026-05-28
K253189Zimmer, Inc. · 510k2026-03-09
K253328Medacta International S.A. · 510k2026-02-26
K253637Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 510k2026-02-18
K253239Signature Orthopaedics Pty, Ltd. · 510k2025-12-23
K253161Ortho Development Corp. · 510k2025-12-19
K252777Maxx Orthopedics, Inc. · 510k2025-10-31
K252044Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 510k2025-10-24

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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