# K063633: Depuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal Sleeves

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Mar 2, 2007 after 86 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K870730 (1987). 11 ancestors in all.
31 later devices descend from it; 3 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040281: LPS Metaphyseal Sleeve (Limb Preservation System), DePuy Orthopaedics, Inc. (2004) Summary page 1.
- K941769: Knee Prothesis, Joint Medical Products Corp. (1995) Summary page 1.

## Most influential descendants
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own
- K162422: Klassic Knee System (2016), 23 descendants of its own
- K180159: Klassic® Knee System (2018), 22 descendants of its own
- K190562: iTotal Identity Cruciate Retaining Knee Replacement System (2019), 15 descendants of its own
- K201023: iTotal® Identity Posterior Stabilized Knee Replacement System (2020), 14 descendants of its own

## Recalls of this device
- Jan 8, 2021 · Class II · Z-1103-2021: The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

## Indications for use
The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are intended for use with the PFC, Sigma PFC, Sigma TC3 Revision Knee, or S-ROM knee prostheses 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 intended 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, giant cell tumors, bone tumors) requiring extensive resection and replacement; patient conditions of noninflammatory degenerative joint 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; severe trauma 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 component are intended for cemented use only.

Source page: https://510kreport.com/device/K063633
Methodology: https://510kreport.com/methodology