# K160700: ATTUNE Revision Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Depuy (Ireland)
- Decided: Jun 10, 2016 after 88 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K943462 (1994). 15 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111433: Depuy Sttune (TM) PS Knee System, DePuy Orthopaedics, Inc. (2011) Summary page 4.
- K952830: Darwin Knee System (TC3), Johnson & Johnson Professionals, Inc. (1996) Summary page 4.

## Most influential descendants
- K240683: Rx Knee System (2024), 2 descendants of its own
- K260063: GSPE Spacer (2026), 0 descendants of its own
- K262130: ATTUNE Revision Knee System (2026), 0 descendants of its own
- K261734: Klassic Infection Spacer System (2026), 0 descendants of its own
- K241000: ATTUNE™ Revision Knee System;  DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System; (2024), 0 descendants of its own

## Recalls of this device
- Jan 5, 2022 · Class II · Z-0631-2022: May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
- Jan 5, 2022 · Class II · Z-0632-2022: May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
- Jul 1, 2021 · Class II · Z-2348-2021: Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
- Apr 16, 2018 · Class II · Z-1703-2018: There may be burrs on the extraction hole threads.
- Apr 16, 2018 · Class II · Z-1704-2018: There may be burrs on the extraction hole threads.

## Indications for use
Candidates for total knee replacement include patients with: A severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis Moderate valgus, varus, or flexion deformities Avascular necrosis of the femoral condyle A previous unsuccessful knee replacement, osteotomy, or other knee procedure ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with: Absence or loss of both cruciate ligaments Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon Bone loss that requires supplemental fixation in the clinical judgment of the surgeon The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications. Any non porous-coated components are intended for cemented use only.

Source page: https://510kreport.com/device/K160700
Methodology: https://510kreport.com/methodology