510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OIYClass II

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

21 CFR 888.3560 / Orthopedic
FDA source (opens on fda.gov)

OIY is the FDA product code for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive, a class II device type, regulated under 21 CFR 888.3560. FDA's definition for this code reads: "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...". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
OIY
Device name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
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.
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
6

Clearances, product code OIY

By decision year
12 clearances under product code OIY with a decision year between 2010 and 2026, 2010 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code OIY by decision year
YearClearances
20104
20112
20122
20131
20201
20241
20261

Applicants with the most clearances

Product code OIY
Applicants holding the most 510(k) clearances under product code OIY
ApplicantClearances
Depuy Orthopaedics Inc.5
Encore Medical, LP4
Biomet Manufacturing Corp1
Depuy Orthopedics, Inc.1
Renovis Surgical Technologies, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 118 companies shown, in name order