FDA product code OIY: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
OIY is the FDA product code for prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive. It is a Class II device, regulated under 21 CFR 888.3560 and reviewed by the Orthopedic panel. FDA has cleared 12 510(k) submissions under OIY, 2 in the last five years, from 5 different applicants. The average 510(k) review took 154 days (median 83); 156 days on average over the last three years. FDA has posted 6 recalls for OIY devices, 2 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
| Device class | Class II |
| Regulation | 21 CFR 888.3560 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OIY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 28 |
| 2024 | 1 | 58 |
| 2026 | 1 | 254 |
Compare with all 510(k) review times · Search every OIY clearance
Top OIY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| DePuy Orthopaedics, Inc. | 5 | 2026-05-22 |
| Encore Medical L.P. | 4 | 2012-08-15 |
| Depuy Orthopedics, Inc. | 1 | 2024-11-01 |
| Renovis Surgical Technologies, LLC | 1 | 2013-02-14 |
| Biomet Manufacturing Corp | 1 | 2010-03-09 |
Most recent OIY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252887 | DePuy Orthopaedics, Inc. | DePuy ATTUNE Knee System | 2026-05-22 | 254 |
| K242665 | Depuy Orthopedics, Inc. | DePuy ATTUNE Total Knee System | 2024-11-01 | 58 |
| K201347 | DePuy Orthopaedics, Inc. | DePuy ATTUNE Total Knee System | 2020-06-18 | 28 |
| K120038 | Renovis Surgical Technologies, LLC | A200 KNEE SYSTEM | 2013-02-14 | 406 |
| K121727 | Encore Medical L.P. | MOVATION KNEE SYSTEM | 2012-08-15 | 64 |
Recalls for OIY devices
6 product recalls in 6 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2023-02-15.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code OIY?
OIY is the FDA product code for prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive. It is a Class II device, regulated under 21 CFR 888.3560 and reviewed by the Orthopedic panel.
What device class is OIY?
Class II, regulation 21 CFR 888.3560. Typical premarket route: 510(k).
How long does a 510(k) take for product code OIY?
Across 12 cleared submissions the average was 154 days from receipt to decision (median 83).
Which companies have the most OIY clearances?
DePuy Orthopaedics, Inc. (5); Encore Medical L.P. (4); Depuy Orthopedics, Inc. (1); Renovis Surgical Technologies, LLC (1); Biomet Manufacturing Corp (1).
Have OIY devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2023-02-15.
Next steps
- Run an FDA pathway report with predicate devices for product code OIY
- Run a recall and safety report across every OIY manufacturer
- Watch product code OIY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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