# 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;

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ireland UC
- Decided: Jul 11, 2024 after 90 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K943462 (1994). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160700: ATTUNE Revision Knee System, Depuy (Ireland) (2016) Summary page 6.
- K063633: Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves, DePuy Orthopaedics, Inc. (2007) Summary page 10.
- K073529: Depuy Sigma PS Femoral Components, DePuy Orthopaedics, Inc. (2008) Summary page 13.
- K062654: Depuy Sigma Cruciate Retaining Porocoat Femoral Components, DePuy Orthopaedics, Inc. (2006) Summary page 13.
- K896048: S-Rom/Noiles Mark 3, Joint Medical Products Corp. (1990) Summary page 16.
- K936037: S-Rom Noiles Cruciate Retaining Knee, Joint Medical Products Corp. (1994) Summary page 16.
- K924940: Femoral & Tibial Augment Block, Joint Medical Products Corp. (1993) Summary page 16.
- K905810: Noiles (TM) Total Knee Prosthesis, Modification, Joint Medical Products Corp. (1991) Summary page 16.
- K870730: Noiles Total Knee Prosthesis, Joint Medical Products Corp. (1987) Summary page 16.
- K060515: Depuy PFC Sigma Knee Prosthesis, DePuy Orthopaedics, Inc. (2006) Summary page 19.
- K984158: P.F.C. Modular Plus Offset Tibial Tray, Depuy, Inc. (1999) Summary page 19.
- K971189: P.F.C. Sigma Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1997) Summary page 19.
- K971652: P.F.C. Sigma Inset Patella, Johnson & Johnson Professionals, Inc. (1997) Summary page 19.
- K963117: P.F.C. Cruciate Retaing Knee System, Johnson & Johnson Professionals, Inc. (1996) Summary page 19.
- K961685: P.F.C. Cruciate Retaining Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1996) Summary page 19.
- K950010: Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated, Johnson & Johnson Professionals, Inc. (1995) Summary page 20.
- K952830: Darwin Knee System (TC3), Johnson & Johnson Professionals, Inc. (1996) Summary page 20.
- K943462: Darwin Knee System, Johnson & Johnson Professionals, Inc. (1994) Summary page 20.
- K923807: P.F.C. Modular Total Knee System, Modular Plus, Johnson & Johnson International (1992) Summary page 20.
- K884796: P.F.C.(TM) Modular Knee System, Johnson & Johnson Professionals, Inc. (1989) Summary page 20.
- K882234: Johnson & Johnson Modular Total Knee Prosthesis, Johnson & Johnson Professionals, Inc. (1988) Summary page 20.
- K040166: Depuy Sigma XLK Tibial Inserts, DePuy Orthopaedics, Inc. (2004) Summary page 20.
- K033272: Depuy Sigma Tibial Inserts, DePuy Orthopaedics, Inc. (2004) Summary page 20.
- K032151: Depuy Sigma Tibial Inserts and CO-CR Tibial Trays, Depuy, Inc. (2003) Summary page 20.

## Indications for use
ATTUNE™ Revision Knee System 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. DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are intended for use with the PFC, PFC Sigma, Sigma TC3 Revision Knee, or S-ROM knee prosthesis in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. These devices are for cemented use only. The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are also intended for use with the DePuy LPS prosthesis for replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: Malignant tumors (e.g., osteosarcomas, chondrosarcomas, gian cell tumors, bone tumors) requiring extensive resection and replacement; patient conditions of noninflammatory degenerative join disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis, requiring extensive resection and replacement; revision for failed previous prosthesis cases requiring extensive resection and replacement. The LPS prosthesis is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required. The Universal Stem and the Universal Metaphyseal Sleeve components are intended for cemented use only. DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in the quality of their lives. THE SIGMA C/R POROCOAT® FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED OR CEMENTLESS USE AS THE FEMORAL COMPONENT OF A TOTAL KNEE REPLACEMENT SYSTEM. THE SIGMA PS FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED USE AS THE FEMORAL COMPONENTS OF A TOTAL KNEE REPLACEMENT SYSTEM. S-ROM™ NOILES™ Rotating Hinge Knee The S-ROM NOILES Rotating Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions: 1. Severe instability, gross deformity and/or bone loss. 2. Failure of a previous knee reconstruction procedure. 3. Trauma or tumor resection. 4. Absent or markedly insufficient collateral ligaments. DePuy P.F.C. ™ SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis The DePuy SIGMA™ and P.F.C. ™SIGMA™ Total Knee Prosthesis are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The DePuy SIGMA™ and P.F.C. ™SIGMA™ Total Knee Prosthesis are intended for cement use only.

Source page: https://510kreport.com/device/K241000
Methodology: https://510kreport.com/methodology