DeviceClearance

Product code PBI— Orthopedic

G7 ACETABULAR SYSTEM

Classification name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
Device class
Class 2
Regulation
21 CFR 888.3310
Advisory panel
Orthopedic
Total cleared
2
First cleared
Most recent

FDA classification definition

“For use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.”

— U.S. Food and Drug Administration, device classification record for product code PBI under 21 CFR 888.3310, via openFDA

Market context for product code PBI

FDA has cleared 2 devices under product code PBI between 2012 and 2022, filed by 2 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 PBI

Adverse events under product code PBI

product code PBI
Injury
499
Malfunction
729
Total
1,228

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 PBI

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