DEPUY LUSTER STEM— 510(k) K983136

Clearance details

Applicant

DePuy Orthopaedics, Inc.

Product code

Code JDI

Device class

Class 2

Regulation

21 CFR 888.3350

Advisory panel

Orthopedic

Date received

1998-09-08

Decision date

1998-11-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments2026-08-24
• K253434 — OSSTM Orthopedic Salvage System2026-07-01
• K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners2025-07-31
• K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems2024-10-21
• K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component2024-08-02

• K262130 — ATTUNE Revision Knee System2026-09-04
• K252887 — DePuy ATTUNE Knee System2026-05-22
• K231503 — CUPTIMIZE Advanced2023-08-22
• K213839 — DePuy Corail AMT Hip Prosthesis2022-01-06
• K210167 — DELTA XTEND Reverse Shoulder System2021-02-19

Death

65

Injury

12,943

Malfunction

1,681

Total

14,689

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1915-2012 — LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.Class II·Terminated·DePuy Orthopaedics, Inc.·20120516
• Z-1916-2012 — LUSTER HIP SZ 2 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.Class II·Terminated·DePuy Orthopaedics, Inc.·20120516
• Z-1917-2012 — LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.Class II·Terminated·DePuy Orthopaedics, Inc.·20120516
• Z-1918-2012 — LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.Class II·Terminated·DePuy Orthopaedics, Inc.·20120516
• Z-1919-2012 — LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.Class II·Terminated·DePuy Orthopaedics, Inc.·20120516
• Z-1920-2012 — LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.Class II·Terminated·DePuy Orthopaedics, Inc.·20120516
• Z-1921-2012 — LUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.Class II·Terminated·DePuy Orthopaedics, Inc.·20120516
• Z-1922-2012 — LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.Class II·Terminated·DePuy Orthopaedics, Inc.·20120516
• Z-1924-2012 — LUSTER HIP SZ 10 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.Class II·Terminated·DePuy Orthopaedics, Inc.·20120516

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983136.