← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3350
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

K253434Biomet, Inc. · 510k2026-07-01
K252824Signature Orthopaedics Pty, Ltd. · 510k2026-03-12
K243571Zimmer Biomet · 510k2025-07-31
K240783Smith & Nephew, Inc. · 510k2024-10-21

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.

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 →