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 Orthopaedics, Inc. and Depuy Orthopedics, Inc..

12
Total
12
Cleared
154d
Avg days
2010
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 156d avg (recent)

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

12 devices
1–12 of 12
Cleared May 22, 2026
DePuy ATTUNE™ Knee System
K252887
DePuy Orthopaedics, Inc.
Orthopedic · 254d
Cleared Nov 01, 2024
DePuy ATTUNE™ Total Knee System
K242665
Depuy Orthopedics, Inc.
Orthopedic · 58d
Cleared Jun 18, 2020
DePuy ATTUNE™ Total Knee System
K201347
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Aug 30, 2011
DEPUY STTUNE (TM) PS KNEE SYSTEM
K111433
DePuy Orthopaedics, Inc.
Orthopedic · 99d
Cleared Mar 15, 2011
DEPUY ATTUNE TOTAL KNEE SYSTEM
K103756
DePuy Orthopaedics, Inc.
Orthopedic · 82d
Cleared Dec 10, 2010
DEPUY ATTUNE KNEE SYSTEM
K101433
DePuy Orthopaedics, Inc.
Orthopedic · 203d

About Product Code OIY - Regulatory Context

510(k) Submission Activity

12 total 510(k) submissions under product code OIY since 2010, with 12 receiving FDA clearance (average review time: 154 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OIY Product Code

FDA review times for OIY submissions have been consistent, averaging 156 days recently vs 153 days historically.

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