510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K934353Substantially Equivalent

Zirconium Alloy Uni-Polar Head

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

K934353 is the FDA 510(k) clearance record for ZIRCONIUM ALLOY UNI-POLAR HEAD, a class II device, cleared for Smith & Nephew Richards, Inc. on under FDA product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). FDA records list 87 510(k) clearances for Smith & Nephew Richards, Inc., from to . As of , FDA records show no recalls naming K934353.

Clearance record

Decision date
Received
(229 days to decision)
Product code
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Smith & Nephew Richards, Inc. 1450 E. Brooks Rd., Memphis TN
510(k) summary
Summary
Third party review
No

Clearances, product code KWL

Trailing 12 months
3 clearances under product code KWL in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWL, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260
November 20260