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510(k) K871118

MODIFIED TOWNLEY UNICONDYLAR KNEE by Depuy, Inc. — Product Code KYK

K871118 is an FDA 510(k) premarket notification submitted by Depuy, Inc. for the device "MODIFIED TOWNLEY UNICONDYLAR KNEE". The FDA issued a decision of SN on April 6, 1987. The device falls under product code KYK (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite), a Class II device regulated under 21 CFR 888.3500. Depuy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
April 6, 1987
Date Received
March 19, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
Device Class
Class II
Regulation Number
888.3500
Review Panel
OR
Submission Type

Other clearances by Depuy, Inc.

  • K043058 — PINNACLE CONSTRAINED ACETABULAR LINERS (March 14, 2005)
  • K042664 — LPS UPPER EXTREMITY (December 8, 2004)
  • K041085 — LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY (July 22, 2004)
  • K033959 — LPS (July 1, 2004)
  • K040544 — DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO (May 28, 2004)
  • K021478 — DELTA SHOULDER (November 18, 2003)
  • K033329 — DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (November 14, 2003)
  • K032151 — DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS (September 26, 2003)
  • K020541 — AGILITY ANKLE REVISION PROSTHESIS (May 20, 2002)
  • K011810 — ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING (September 7, 2001)

Other clearances for product code KYK

  • K880826 — MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM (March 14, 1988)
  • K851341 — SYNATOMIC VARIABLE FIT TIBIAL PLATEAU (July 15, 1985)

FDA data resources