DeviceClearance

Product code HTY— Orthopedic

K-WIRE

Classification name
Pin, Fixation, Smooth
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Total cleared
205
First cleared
Most recent

Market context for product code HTY

FDA has cleared 205 devices under product code HTY between 1977 and 2026, filed by 137 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 HTY

Adverse events under product code HTY

product code HTY
Injury
544
Total
544

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 HTY

1–100 of 205

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