# K983136: Depuy Luster Stem

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Nov 25, 1998 after 78 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K891454 (1989). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942370: Depuy Cemented Hip Prosthesis, Depuy, Inc. (1994) Summary page 1.
- K960658: Collarless Polished Taper Hip Prosthesis, Zimmer, Inc. (1996) Summary page 1.
- K974054: Distal Centralizer, Exeter II Hip System, Howmedica, Inc. (1997) Summary page 1.
- K980843: Exeter Intramedullary Bone Plug, Howmedica, Inc. (1998) Summary page 1.

## Recalls of this device
- May 16, 2012 · Class II · Z-1921-2012: DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on
- May 16, 2012 · Class II · Z-1920-2012: DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on
- May 16, 2012 · Class II · Z-1915-2012: DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on
- May 16, 2012 · Class II · Z-1917-2012: DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on
- May 16, 2012 · Class II · Z-1924-2012: DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on
- May 16, 2012 · Class II · Z-1922-2012: DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on
- May 16, 2012 · Class II · Z-1918-2012: DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on
- May 16, 2012 · Class II · Z-1919-2012: DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on
- May 16, 2012 · Class II · Z-1916-2012: DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on
- Feb 22, 2005 · Not classified · Z-1549-05: Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec.

## Indications for use
The DePuy Luster Stem is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty.

Source page: https://510kreport.com/device/K983136
Methodology: https://510kreport.com/methodology