# K191779: Attune Revision LPS Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Depuy (Ireland)
- Decided: Oct 8, 2019 after 98 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K943462 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091453: LPS Universal Tibial Hinge Inserts, Model 198727012-198727331, DePuy Orthopaedics, Inc. (2009) Summary page 4.
- K101433: Depuy Attune Knee System, DePuy Orthopaedics, Inc. (2010) Summary page 4.
- K111433: Depuy Sttune (TM) PS Knee System, DePuy Orthopaedics, Inc. (2011) Summary page 4.
- K160700: ATTUNE Revision Knee System, Depuy (Ireland) (2016) Summary page 4.

## Recalls of this device
- Feb 15, 2023 · Class II · Z-1265-2023: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may re
- Feb 15, 2023 · Class II · Z-1263-2023: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may re
- Feb 15, 2023 · Class II · Z-1264-2023: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may re
- Feb 15, 2023 · Class II · Z-1266-2023: The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may re

## Indications for use
The ATTUNE Revision LPS Insert is intended for use in prosthetic constructs for replacement of distal and/or total femur and resurfacing of the proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: • malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement; • patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement; • revision cases for a failed previous prosthesis requiring extensive resection and replacement; • severe trauma requiring extensive resection and replacement. • post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required.

Source page: https://510kreport.com/device/K191779
Methodology: https://510kreport.com/methodology