510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851341Substantially Equivalent

Synatomic Variable Fit Tibial Plateau

Depuy, Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851341 is the FDA 510(k) clearance record for SYNATOMIC VARIABLE FIT TIBIAL PLATEAU, a class II device, cleared for Depuy, Inc. on under FDA product code KYK (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite). FDA records list 220 510(k) clearances for Depuy, Inc., from to . As of , FDA records show no recalls naming K851341.

Clearance record

Decision date
Received
(103 days to decision)
Product code
KYK Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
Regulation
21 CFR 888.3500
Device class
Class II
Review panel
Orthopedic
Applicant
Depuy, Inc. P.O. Box 988, Warsaw IN
Third party review
No

Clearances, product code KYK

Trailing 12 months

FDA records hold no clearances under product code KYK in the trailing twelve months.

FDA records show no clearances under product code KYK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KYK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260