← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

HSN — Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3110
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES

Recent clearances

K253159Wright Medical Technology, Inc. (Stryker) · 510k2026-06-16
K252454Restor3D · 510k2025-09-03
K250037Wright Medical Technology, Inc. (Stryker) · 510k2025-06-20
K250641Paragon 28, Inc. · 510k2025-05-01
K240475Vilex, LLC · 510k2024-12-02
K241999Wright Medical Technology, Inc. (Stryker) · 510k2024-11-01
K242868Restor3D · 510k2024-10-18

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →