DeviceClearance

Product code PML— Orthopedic

BonOs Inject Bone Cement; NEO Pedicle Screw System

Classification name
Bone Cement, Posterior Screw Augmentation
Device class
Class 2
Regulation
21 CFR 888.3027
Advisory panel
Orthopedic
Total cleared
19
First cleared
Most recent

FDA classification definition

“The device is intended to augment the fixation of screws in a posterior spinal system construct.”

— U.S. Food and Drug Administration, device classification record for product code PML under 21 CFR 888.3027, via openFDA

Market context for product code PML

FDA has cleared 19 devices under product code PML between 2016 and 2026, filed by 16 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

Top applicants under product code PML

Adverse events under product code PML

product code PML
Death
8
Total
8

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 PML

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