Atlas FDA

Attune Revision LPS Inserts

FDA 510(k) clearance K191779 · decided 2019-10-08

Clearance details

K-number
K191779
Device name
Attune Revision LPS Inserts
Applicant
Depuy(Ireland)
Decision
Substantially Equivalent
Date received
2019-07-02
Decision date
2019-10-08
Days to decision
98 days
Clearance type
Traditional
Product code
KRO
Device class
2
Regulation number
888.3510
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Cork, IE
Third-party review
No
Expedited review
No

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ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System (K233980)Depuy Ireland UC2024-03-21
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Recalls involving this device

RecordFirmDate
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760 recall (Z-1263-2023)DePuy Orthopaedics, Inc.2023-03-17
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 1517602 recall (Z-1264-2023)DePuy Orthopaedics, Inc.2023-03-17
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 1517602 recall (Z-1265-2023)DePuy Orthopaedics, Inc.2023-03-17
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 15176031 recall (Z-1266-2023)DePuy Orthopaedics, Inc.2023-03-17