LZY
8 FDA 510(k) clearances · Product code
90 daysmedian time to decision
567 days90th percentile
8clearances measured
FDA profile
- Official device name
- Prosthesis, Hip, Hemi-, Femoral, Metal Ball
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Medical specialty
- Orthopedic
- Flags
- Implant
- Adverse events (MAUDE)
- 2021: 59 · 2022: 65 · 2023: 77 · 2024: 74 · 2025: 77 · 2026: 40
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TANDEM Hip System (K231448) | Smith & Nephew, Inc. | 2023-07-19 |
| ENDO HEAD (K111145) | Medacta International | 2011-08-16 |
| PRE-POWDERED NITRILE EXAMINATION GLOVES (K974442) | P.T. Latexindo Tobaperkasa | 1998-01-05 |
| BHR BIPOLAR FEMORAL HEAD COMPONENT (K915528) | Implantology Corp. | 1993-06-29 |
| IONGUARD TITANIUM MODULAR HEADS (K915548) | Biomet, Inc. | 1992-03-10 |
| MODULAR CATHCART FRACTURE SYSTEM (K903084) | Depuy, Inc. | 1990-10-03 |
| UNI-POLAR HEAD (K896580) | Richards Medical Co., Inc. | 1990-02-15 |
| FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR (K892059) | Protek, Inc. | 1989-07-19 |
Track LZY automatically
Every clearance here is in the API, with alerts when new ones post.