OIY

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive

Product code: OIY
Device name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Device class: Class 2
21 CFR: 21 CFR 888.3560
Medical specialty: Orthopedic
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (last 3 years): 12

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-05-22.

Number	Decision date	Applicant	Device name	Summary
K252887	2026-05-22	DePuy Orthopaedics, Inc.	DePuy ATTUNE Knee System	PDF
K242665	2024-11-01	Depuy Orthopedics, Inc.	DePuy ATTUNE Total Knee System	FDA

1 summaries are archived here for direct download.

Official FDA classification page: OIY

Classification and pathway per current FDA publications. Data from openFDA (CC0).