Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
The Femorotibial Semi-Constrained Cemented Metal/Composite Knee Prosthesis is an orthopedic implant used in total knee arthroplasty to replace both the femoral and tibial articular surfaces with a cemented semi-constrained design, providing some intrinsic stability while retaining partial dependence on soft tissue structures. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KYK, regulated under 21 CFR 888.3500, in the Orthopedic medical specialty. This device is an implant.
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Basic Information
- Product Code
- KYK
- Device Class
- FDA class 2
- Regulation Number
- 888.3500
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K880826 | MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM | Mar 14, 1988 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
| K871118 | MODIFIED TOWNLEY UNICONDYLAR KNEE | Apr 06, 1987 | Substantially Equivalent for Some Indications | Depuy, Inc. |
| K851341 | SYNATOMIC VARIABLE FIT TIBIAL PLATEAU | Jul 15, 1985 | Substantially Equivalent | Depuy, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.