510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K081111Substantially Equivalent

Legion Hinge Knee System

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

K081111 is the FDA 510(k) clearance record for LEGION HINGE KNEE SYSTEM, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show 7 recalls naming K081111.

Clearance record

Decision date
Received
(96 days to decision)
Product code
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3510
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 KRO

Trailing 12 months
2 clearances under product code KRO in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KRO, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260