DeviceClearance

Product code FTM— General, Plastic Surgery

DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

Classification name
Mesh, Surgical
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
164
First cleared
Most recent

Market context for product code FTM

FDA has cleared 164 devices under product code FTM between 1982 and 2026, filed by 73 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 FTM

Adverse events under product code FTM

product code FTM
Death
17
Injury
2,174
Total
2,191

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 FTM

1–100 of 164

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