DeviceClearance

Product code OIY— Orthopedic

A200 KNEE SYSTEM

Classification name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
Device class
Class 2
Regulation
21 CFR 888.3560
Advisory panel
Orthopedic
Total cleared
12
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OIY under 21 CFR 888.3560, via openFDA

Market context for product code OIY

FDA has cleared 12 devices under product code OIY between 2010 and 2026, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OIY

Adverse events under product code OIY

product code OIY
Injury
607
Total
607

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OIY

Data sourced from openFDA. This site is unofficial and independent of the FDA.