← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3510
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K252898Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 510k2025-12-15
K252303United Orthopedic Corporation · 510k2025-08-22
K251665Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 510k2025-07-25
K242871Depuy Ireland UC · 510k2024-11-21

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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