OIY · Class II · 21 CFR 888.3560

FDA Product Code OIY: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive

Indicated For: 1. Painful And Disabled Knee Joint Resulting From Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis Where One Or More Compartments Are Involved. 2. Correction Of Varus, Valgus, Or Posttraumatic Deformity. 3. Correction Or Revision Of Unsuccessful Osteotomy, Arthrodesis, Or Failure Of Previous Joint Replacement Procedure. For Cemented Use.

Leading manufacturers include Depuy Orthopedics, Inc..

11
Total
11
Cleared
144d
Avg days
2010
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 58d recently vs 153d historically

FDA 510(k) Cleared Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive Devices (Product Code OIY)

11 devices
1–11 of 11
Cleared Nov 01, 2024
DePuy ATTUNE™ Total Knee System
K242665
Depuy Orthopedics, Inc.
Orthopedic · 58d

About Product Code OIY - Regulatory Context

510(k) Submission Activity

11 total 510(k) submissions under product code OIY since 2010, with 11 receiving FDA clearance (average review time: 144 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under OIY have taken an average of 58 days to reach a decision - down from 153 days historically, suggesting improved FDA processing for this classification.

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