Atlas FDA

SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE

FDA 510(k) clearance K042515 · decided 2005-03-14

Clearance details

K-number
K042515
Device name
SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2004-09-16
Decision date
2005-03-14
Days to decision
179 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
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 7 recall (Z-0001-2019)Smith & Nephew, Inc.2018-10-01
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112 recall (Z-0002-2019)Smith & Nephew, Inc.2018-10-01
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114 recall (Z-0003-2019)Smith & Nephew, Inc.2018-10-01

PMA approvals by this applicant

RecordFirmDate
Ascension MCP (P000057/S013)Smith & Nephew, Inc.2025-12-31
ASCENSION MCP (P000057/S014)Smith & Nephew, Inc.2025-08-05
R3™ Delta Ceramic Acetabular System (P150030/S049)Smith & Nephew, Inc.2025-04-17
R3 DELTA CERAMIC HIP SYSTEM (P150030/S048)Smith & Nephew, Inc.2025-03-03
R3 Delta Ceramic Hip System (P150030/S045)Smith & Nephew, Inc.2025-02-28
R3™ Delta Ceramic Acetabular System (P150030/S047)Smith & Nephew, Inc.2025-02-21
R3™ Delta Ceramic Acetabular System (P150030/S046)Smith & Nephew, Inc.2025-01-16
BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM (P040033/S039)Smith & Nephew, Inc.2025-01-10