Atlas FDA

DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS

FDA 510(k) clearance K140881 · decided 2015-02-13

Clearance details

K-number
K140881
Device name
DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
Applicant
Depuy(Ireland)
Decision
Substantially Equivalent
Date received
2014-04-07
Decision date
2015-02-13
Days to decision
312 days
Clearance type
Traditional
Product code
MBH
Device class
2
Regulation number
888.3565
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Co. Cork, IE
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface recall (Z-2137-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface T recall (Z-2138-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface T recall (Z-2139-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articula recall (Z-2140-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface T recall (Z-2141-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surfac recall (Z-2142-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface recall (Z-2143-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps to recall (Z-2144-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface T recall (Z-2145-2015)DePuy Orthopaedics, Inc.2015-07-20
ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snap recall (Z-2146-2015)DePuy Orthopaedics, Inc.2015-07-20