OOG · Class II · 21 CFR 888.3560

FDA Product Code OOG: Knee Arthroplasty Implantation System

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.

Leading manufacturers include Conformis, Inc..

2
Total
2
Cleared
209d
Avg days
2021
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Knee Arthroplasty Implantation System Devices (Product Code OOG)

2 devices
1–2 of 2
Cleared Apr 19, 2021
Triathlon AS-1
K203421
Conformis, Inc.
Orthopedic · 150d

About Product Code OOG - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code OOG since 2021, with 2 receiving FDA clearance (average review time: 209 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

OOG devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →