# K040166: Depuy Sigma XLK Tibial Inserts

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Feb 23, 2004 after 28 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: 2 generations back to K943462 (1994). 5 ancestors in all.
324 later devices descend from it; 5 cite it directly.
0 of 330 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033272: Depuy Sigma Tibial Inserts, DePuy Orthopaedics, Inc. (2004). Cleared while this submission was under review Summary page 1.
- K943462: Darwin Knee System, Johnson & Johnson Professionals, Inc. (1994) Summary page 1.
- K950010: Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated, Johnson & Johnson Professionals, Inc. (1995) Summary page 1.
- K961685: P.F.C. Cruciate Retaining Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1996) Summary page 1.
- K971189: P.F.C. Sigma Knee System (Size 1.5), Johnson & Johnson Professionals, Inc. (1997) Summary page 1.

## Most influential descendants
- K052472: Depuy Global Shoulder Crosslink Glenoid (2005), 158 descendants of its own
- K101433: Depuy Attune Knee System (2010), 114 descendants of its own
- K092122: Global Shoulder Steptech Anchor Peg Glenoid (2009), 75 descendants of its own
- K061648: Depuy Graduated Compartmental Knee (GCK) (2006), 61 descendants of its own
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own

## Indications for use
The Sigma XLK Tibial Inserts 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.

Source page: https://510kreport.com/device/K040166
Methodology: https://510kreport.com/methodology