OOG — Knee Arthroplasty Implantation System Class II

FDA Device Classification

Classification Details

Product Code: OOG
Device Class: Class II
Regulation Number: 888.3560
Submission Type
Review Panel: OR
Medical Specialty: Orthopedic
Implant: No

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.

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K230850	enhatch	United Orthopedic Knee Patient Specific Instrumentation	December 20, 2023
K203421	conformis	Triathlon AS-1	April 19, 2021