← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3520
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES

Recent clearances

K260796Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics · 510k2026-04-02
K251771Signature Orthopaedics Pty, Ltd. · 510k2025-12-16
K251834Zimmer Biomet · 510k2025-08-15
K251618Medacta International S.A. · 510k2025-07-24
K251453Arthrex, Inc. · 510k2025-07-01
K241260Globus Medical, Inc. · 510k2024-12-06
K242711Smith & Nephew, Inc. · 510k2024-10-30
K242746Overture Orthopaedics · 510k2024-10-07

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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