DeviceClearance

Product code OOG— Orthopedic

Triathlon AS-1

Classification name
Knee Arthroplasty Implantation System
Device class
Class 2
Regulation
21 CFR 888.3560
Advisory panel
Orthopedic
Total cleared
2
First cleared
Most recent

FDA classification definition

“Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.”

— U.S. Food and Drug Administration, device classification record for product code OOG under 21 CFR 888.3560, via openFDA

Market context for product code OOG

FDA has cleared 2 devices under product code OOG between 2021 and 2023, 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 OOG

Adverse events under product code OOG

product code OOG
Injury
153
Total
153

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 OOG

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