Modified Townley Unicondylar Knee

FDA 510(k) K871118 · Depuy, Inc.

Substantially Equivalent for Some Indications

510(k) numberK871118

Submission

Device name
Modified Townley Unicondylar Knee
Applicant
Depuy, Inc.
Warsaw, IN, US
Received
March 19, 1987
Decision date
April 6, 1987
Decision
Substantially Equivalent for Some Indications (SN)
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
K880826Microloc(Tm) Porous Coated Unicondylar Knee SystemKYK · Traditional Johnson & Johnson Professionals, Inc.03/14/1988SE
K851341Synatomic Variable Fit Tibial PlateauKYK · Traditional Depuy, Inc.07/15/1985SE

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K033959LPSJWH · Traditional 07/01/2004SE
K040544Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…LPH · Traditional 05/28/2004SE
K021478Delta ShoulderPHX · Traditional 11/18/2003SE
K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional 11/14/2003SE
K032151Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special 09/26/2003SE
K020541Agility Ankle Revision ProsthesisHSN · Traditional 05/20/2002SE
K011810Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial BearingKRO · Traditional 09/07/2001SE

Questions and answers

When was Modified Townley Unicondylar Knee cleared by the FDA?

Modified Townley Unicondylar Knee (K871118) received a 510(k) decision of Substantially Equivalent for Some Indications on April 6, 1987, 18 days after the submission was received.

What is the product code of K871118?

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.