510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K012778Substantially Equivalent

Vaporized Hydrogen Peroxide (Vhp) Sterilization of Uhmwpe Components in the Genesis Knee System, the Genesis II Knee Sys

Smith & Nephew, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012778 is the FDA 510(k) clearance record for VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K012778.

Clearance record

Decision date
Received
(207 days to decision)
Product code
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation
21 CFR 888.3560
Device class
Class II
Review panel
Orthopedic
Applicant
Smith & Nephew, Inc. 1450 Brooks Rd., Memphis TN
510(k) summary
Summary
Third party review
No

Clearances, product code JWH

Trailing 12 months
13 clearances under product code JWH in the twelve months to November 2026, September 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code JWH, trailing twelve months
MonthClearances
December 20251
January 20261
February 20260
March 20260
April 20261
May 20260
June 20261
July 20262
August 20261
September 20266
October 20260
November 20260