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. and Enhatch, 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
Cleared
Dec 20, 2023
United Orthopedic Knee Patient Specific Instrumentation
Enhatch, Inc.
Orthopedic
267d
Cleared
Apr 19, 2021
Triathlon AS-1
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.