← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3560
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
29
510(K)/PMA CLEARANCES
510k: 29
0
RECALL ENTRIES

Recent clearances

K261458DePuy Ireland UC · 510k2026-06-25
K261032NovoSource · 510k2026-04-27
K253793Materialise NV · 510k2026-01-06
K252974Encore Medical L.P. · 510k2025-12-19
K253197Depuy Ireland UC · 510k2025-11-19
K253314Maxx Orthopedics, Inc. · 510k2025-10-29
K253144Maxx Orthopedics, Inc. · 510k2025-10-22
K252725United Orthopedic Corporation · 510k2025-09-25

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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