510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K946236Substantially Equivalent

Profix Conforming Plus Tibial Insert

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

K946236 is the FDA 510(k) clearance record for PROFIX CONFORMING PLUS TIBIAL INSERT, a class II device, cleared for Smith & Nephew Richards, Inc. on under FDA product code KWH (Prosthesis, Toe, Constrained, Polymer). FDA records list 87 510(k) clearances for Smith & Nephew Richards, Inc., from to . As of , FDA records show no recalls naming K946236.

Clearance record

Decision date
Received
(196 days to decision)
Product code
KWH Prosthesis, Toe, Constrained, Polymer
Regulation
21 CFR 888.3720
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 KWH

Trailing 12 months

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

FDA records show no clearances under product code KWH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWH, 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