510(k) Report

FDA applicant

Depuy, Inc.

Warsaw, IN307 decisions1976–200537 recalls

FDA records 307 decisions for Depuy, Inc. (Warsaw, IN) from 1976 to 2005: 303 510(k) clearances and 4 original PMA approvals. Most are in product codes JDI (Prosthesis, Hip, Semi-Constrained…) and JWH (Prosthesis, Knee, Patellofemorotibial…). Its devices cite 75 predicates, 25 of them its own earlier devices. 37 recalls are linked to its devices, 1 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Depuy, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Depuy, Inc. since 2007.

Recalls per year

1in 2022

2007: 22011: 52013: 13, 1 Class I2015: 22016: 12021: 82022: 1
2007high 13 (2013) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Depuy, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Depuy, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented45decisions
  • JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer31decisions
  • LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented24decisions
  • HWCScrew, Fixation, Bone14decisions
  • LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous…12decisions
  • KWPAppliance, Fixation, Spinal Interlaminal11decisions

Also: KWL (7), HRY (6), HSB (6), KWQ (6), MBV (5), HSX (5).

Whose devices does it build on?

Its devices cite 75 predicates; 25 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 403 times; 25 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K955348Titanium Moss Miami Spinal SystemDepuy, Inc. · 199634cite it
  • K983583Depuy Acromed Moss and Moss Miami Spinal SystemsDepuy, Inc. · 199826cite it
  • K021478Delta ShoulderDepuy, Inc. · 200319cite it
  • K960385Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 199617cite it
  • K933881Depuy Motech Moss-Miami Spinal SystemDepuy, Inc. · 199415cite it
  • K964024Depuy Motech Titanium Moss Miami Spinal SystemDepuy, Inc. · 199714cite it

What has FDA decided for it lately?

  • K043058Pinnacle Constrained Acetabular LinersDepuy, Inc. · 2005
  • K042664LPS Upper ExtremityDepuy, Inc. · 2004
  • K041085LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryDepuy, Inc. · 20041 Class I recall
  • K033959LPSDepuy, Inc. · 2004
  • K040544Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062 and 1599-21-044 to -062Depuy, Inc. · 2004
  • K021478Delta ShoulderDepuy, Inc. · 2003
  • K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
  • K032151Depuy Sigma Tibial Inserts and CO-CR Tibial TraysDepuy, Inc. · 200312 recalls

All 307 as Depuy, Inc. →

What has been recalled?

37 recalls linked to its devices; the latest:

  • K903084MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral…May 18, 2022Class II
  • P830055TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be…Aug 10, 2021Class II
  • P830055TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be…Aug 10, 2021Class II
  • P830055TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be…Aug 10, 2021Class II
  • P830055TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be…Aug 10, 2021Class II
  • P830055TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be…Aug 10, 2021Class II

Other applicant names beginning “Depuy”

FDA records each applicant name separately; these may or may not be the same firm.

DePuy Orthopaedics, Inc. 213Depuy Spine, Inc. 73Depuy Mitek, A Johnson & Johnson Company 59Depuy Ireland UC 50DePuy Synthes 20Depuy Mitek 15Depuy (Ireland) 13Depuy Ace Medical Co. 10Depuy Mitek, Inc., A Johnson and Johnson Company 6Depuy Motech Acromed 4Depuy France S.A.S. 4Depuy Spine, A Johnson & Johnson Company 4