Atlas FDA

SMITH & NEPHEW, INC. REVISION KNEE SYSTEM

FDA 510(k) clearance K043440 · decided 2005-02-18

Clearance details

K-number
K043440
Device name
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2004-12-14
Decision date
2005-02-18
Days to decision
66 days
Clearance type
Abbreviated
Product code
JWH
Device class
2
Regulation number
888.3560
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 7142 recall (Z-0277-2025)Smith & Nephew Inc2024-10-30
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 7142 recall (Z-0278-2025)Smith & Nephew Inc2024-10-30
LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Mem recall (Z-1819-2009)Smith & Nephew Inc2009-08-23
LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Mem recall (Z-1820-2009)Smith & Nephew Inc2009-08-23

PMA approvals by this applicant

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