DeviceClearance

Product code MBF— Orthopedic

Identity Shoulder System

Classification name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Device class
Class 2
Regulation
21 CFR 888.3670
Advisory panel
Orthopedic
Total cleared
37
First cleared
Most recent

Market context for product code MBF

FDA has cleared 37 devices under product code MBF between 1985 and 2026, filed by 15 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 MBF

Adverse events under product code MBF

product code MBF
Injury
597
Total
597

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 MBF

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