510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K012788Substantially Equivalent

Vaporized Hydrogen Peroxide (Vhp) Sterilization of Unmwpe Components in the Cofield Total Shoulder System, the Neer II

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

K012788 is the FDA 510(k) clearance record for VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K012788.

Clearance record

Decision date
Received
(207 days to decision)
Product code
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Regulation
21 CFR 888.3660
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 KWS

Trailing 12 months
2 clearances under product code KWS in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260