OIY · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3560
Classification
FDA Product Code
OIY
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 888.3560
Review panel
OR
Medical specialty
Orthopedic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.