Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
The Patellofemorotibial Knee Prosthesis (Semi-Constrained, Cemented, Polymer+Additive/Metal/Polymer+Additive) is a total knee replacement implant system used for painful and disabled knee joints resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis involving one or more compartments, and also for correcting varus, valgus, or posttraumatic deformity, or revising failed prior procedures; it is intended for cemented fixation only. Classified as FDA Class 2 under regulation 21 CFR 888.3560 within the Orthopedic medical specialty, it requires a 510(k) premarket notification. The product code is OIY. It is flagged as an implant device.
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Basic Information
- Product Code
- OIY
- Device Class
- FDA class 2
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252887 | DePuy ATTUNE Knee System | May 22, 2026 | Substantially Equivalent | DePuy Orthopaedics, Inc. |
| K242665 | DePuy ATTUNE Total Knee System | Nov 01, 2024 | Substantially Equivalent | Depuy Orthopedics, Inc. |
| K201347 | DePuy ATTUNE Total Knee System | Jun 18, 2020 | Substantially Equivalent | DePuy Orthopaedics, Inc. |
| K120038 | A200 KNEE SYSTEM | Feb 14, 2013 | Substantially Equivalent | Renovis Surgical Technologies, LLC |
| K121727 | MOVATION KNEE SYSTEM | Aug 15, 2012 | Substantially Equivalent | Encore Medical L.P. |
| K113756 | HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA | Mar 14, 2012 | Substantially Equivalent | Encore Medical L.P. |
| K111433 | DEPUY STTUNE (TM) PS KNEE SYSTEM | Aug 30, 2011 | Substantially Equivalent | DePuy Orthopaedics, Inc. |
| K103756 | DEPUY ATTUNE TOTAL KNEE SYSTEM | Mar 15, 2011 | Substantially Equivalent | DePuy Orthopaedics, Inc. |
| K103223 | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS | Dec 21, 2010 | Substantially Equivalent | Encore Medical L.P. |
| K101433 | DEPUY ATTUNE KNEE SYSTEM | Dec 10, 2010 | Substantially Equivalent | DePuy Orthopaedics, Inc. |
| K091956 | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 | Sep 28, 2010 | Substantially Equivalent | Encore Medical L.P. |
| K100048 | E1 ANTIOXIDANT INFUSED TECHNOLOGY | Mar 09, 2010 | Substantially Equivalent | Biomet Manufacturing Corp |
FEI Numbers
This FDA classification entry is associated with 144 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 144 registration numbers. Click on an entry to view related FDA registrations.