OIY

12 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 888.3560

Medical specialty

Orthopedic

Flags

Implant

FDA 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.

Adverse events (MAUDE)

2021: 379 · 2022: 42 · 2023: 40 · 2024: 34 · 2025: 37 · 2026: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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