510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K091543Substantially Equivalent

Legion Porous Plus Ha Primary Femoral Components

Smith & Nephew, Inc., Memphis TN / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091543 is the FDA 510(k) clearance record for LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K091543.

Clearance record

Decision date
Received
(209 days to decision)
Product code
MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation
21 CFR 888.3565
Device class
Class II
Review panel
Orthopedic
Applicant
Smith & Nephew, Inc. 1450 E. Brooks Rd., Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBH

Trailing 12 months
9 clearances under product code MBH in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MBH, trailing twelve months
MonthClearances
December 20252
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20262
October 20260
November 20260