DeviceClearance

Product code LZO— Orthopedic

DePuy Corail AMT Hip Prosthesis

Classification name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class
Class 2
Regulation
21 CFR 888.3353
Advisory panel
Orthopedic
Total cleared
533
First cleared
Most recent

Market context for product code LZO

FDA has cleared 533 devices under product code LZO between 1985 and 2026, filed by 108 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LZO

Adverse events under product code LZO

product code LZO
Death
17
Injury
12,942
Malfunction
1,756
Total
14,715

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LZO

1–100 of 533

Data sourced from openFDA. This site is unofficial and independent of the FDA.