Microloc(Tm) Porous Coated Unicondylar Knee System

FDA 510(k) K880826 · Johnson & Johnson Professionals, Inc.

Substantially Equivalent

510(k) numberK880826

Submission

Device name
Microloc(Tm) Porous Coated Unicondylar Knee System
Applicant
Johnson & Johnson Professionals, Inc.
Raynham, MA, US
Received
March 1, 1988
Decision date
March 14, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KYK – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3500
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KYK

510(k)DeviceApplicantDecision
K871118Modified Townley Unicondylar KneeKYK · Traditional Depuy, Inc.04/06/1987SN
K851341Synatomic Variable Fit Tibial PlateauKYK · Traditional Depuy, Inc.07/15/1985SE

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Questions and answers

When was Microloc(Tm) Porous Coated Unicondylar Knee System cleared by the FDA?

Microloc(Tm) Porous Coated Unicondylar Knee System (K880826) received a 510(k) decision of Substantially Equivalent on March 14, 1988, 13 days after the submission was received.

What is the product code of K880826?

The FDA product code is KYK – Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite, a Class II (moderate risk) device regulated under 21 CFR 888.3500.