Atlas FDA

DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED

FDA 510(k) clearance K950010 · decided 1995-05-15

Clearance details

K-number
K950010
Device name
DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED
Applicant
Johnson & Johnson Professionals, Inc.
Decision
Substantially Equivalent for Some Indications
Date received
1995-01-03
Decision date
1995-05-15
Days to decision
132 days
Clearance type
Traditional
Product code
JWH
Device class
2
Regulation number
888.3560
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Raritan, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0 mm, recall (Z-0385-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 10.0 mm, recall (Z-0386-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 12.5 mm, recall (Z-0387-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 15.0 mm, recall (Z-0388-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 8.0 mm, recall (Z-0389-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 10.0 mm, recall (Z-0390-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 12.5 mm, recall (Z-0391-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 10.0 mm, recall (Z-0392-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 12.5 mm, recall (Z-0393-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee SystemStabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 15.0 mm, recall (Z-0394-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 89 mm M/L, 59 mm A/P, 10.0 mm, recall (Z-0395-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 71mm M/L, 47mm A/P, 15.0mm, recall (Z-0418-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 8.0mm, 4 recall (Z-0419-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, recall (Z-0420-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P recall (Z-0421-2008)Depuy Orthopaedics, Inc.2007-12-06
Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P recall (Z-0422-2008)Depuy Orthopaedics, Inc.2007-12-06