# K032151: Depuy Sigma Tibial Inserts and CO-CR Tibial Trays

- Pathway: 510(k) (Special)
- Applicant: Depuy, Inc.
- Decided: Sep 26, 2003 after 74 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: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943462 (1994). 1 ancestor in all.
118 later devices descend from it; 5 cite it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943462: Darwin Knee System, Johnson & Johnson Professionals, Inc. (1994) Summary page 1.

## Most influential descendants
- K101433: Depuy Attune Knee System (2010), 114 descendants of its own
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own
- K111433: Depuy Sttune (TM) PS Knee System (2011), 39 descendants of its own
- K140833: Itotal Posterior Stabilized (PS) Knee Replacement System (2014), 26 descendants of its own
- K142404: iTotal Posterior Stabilized (PS) Knee Replacement System (2014), 24 descendants of its own

## Recalls of this device
- Nov 18, 2013 · Class II · Z-0413-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0420-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0412-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0415-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0419-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0416-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0423-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0414-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0417-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0418-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0421-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat
- Nov 18, 2013 · Class II · Z-0422-2014: DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the pat

## Indications for use
The Sigma Co-Cr Tibial Trays 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 Sigma Co-Cr Tibial Trays are intended for cemented use only.

Source page: https://510kreport.com/device/K032151
Methodology: https://510kreport.com/methodology