Atlas FDA

SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL

FDA 510(k) clearance K052265 · decided 2005-12-27

Clearance details

K-number
K052265
Device name
SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL
Applicant
Smith & Nephew, Inc.
Decision
Substantially Equivalent
Date received
2005-08-19
Decision date
2005-12-27
Days to decision
130 days
Clearance type
Abbreviated
Product code
NPJ
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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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
RESTORIS Multicompartmental Knee System (K150307)Mako Surgical Corp.2015-03-10
RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM (K133039)Mako Surgical Corporation2013-12-10
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM (K093513)Conformis, Inc.2009-12-16
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM (K093056)Smith & Nephew, Inc.2009-12-15
RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM (K090763)Mako Surgical Corporation2009-06-17
DEPUY GCK FEMORAL AND TIBIAL COMPONENTS (K070849)DePuy Orthopaedics, Inc.2007-06-26
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) (K061648)DePuy Orthopaedics, Inc.2006-09-11
SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS (K061569)Smith & Nephew, Inc.2006-07-06
CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM (K053488)Conformis, Inc.2006-03-09
STRYKER COMPARTMENTAL KNEE SYSTEM (K052917)Howmedica Osteonics Corp.2005-12-27
SMITH & NEPHEW HYBRID KNEE FEMORAL (K042896)Smith & Nephew, Inc.2005-01-12

Recalls involving this device

RecordFirmDate
JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDICAL/TIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 7142 recall (Z-0924-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422 recall (Z-0925-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 46MM, M/L 27 MM, REF 714222 recall (Z-0926-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 49 MM, M/L 29 MM, REF 71422 recall (Z-0927-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422 recall (Z-0928-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 55 MM, M/L 32 MM, REF 71422 recall (Z-0929-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422 recall (Z-0930-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422 recall (Z-0931-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 49 MM, M/L 29 MM, REF 71422 recall (Z-0932-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422 recall (Z-0933-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 55 MM, M/L 32 MM, REF 71422 recall (Z-0934-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422241, recall (Z-0935-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422243, recall (Z-0936-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422244, recall (Z-0937-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422245, recall (Z-0938-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422246, recall (Z-0939-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422247, recall (Z-0940-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422248, recall (Z-0941-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422251 recall (Z-0942-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422252 recall (Z-0943-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422253 recall (Z-0944-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422254 recall (Z-0945-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422255 recall (Z-0946-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422256 recall (Z-0947-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422257 recall (Z-0948-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422258 recall (Z-0949-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422261 recall (Z-0950-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422262 recall (Z-0951-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422263 recall (Z-0952-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422264 recall (Z-0953-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422265 recall (Z-0954-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422266 recall (Z-0955-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422267 recall (Z-0956-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422268 recall (Z-0957-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933296 recall (Z-0958-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933297 recall (Z-0959-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933298 recall (Z-0960-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933299 recall (Z-0961-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933300 recall (Z-0962-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933301 recall (Z-0963-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933302 recall (Z-0964-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933303 recall (Z-0965-2010)Smith & Nephew Inc2010-03-03

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