Medical device manufacturer

Depuy, Inc.

Depuy, Inc. holds 303 FDA 510(k) clearances across 90 product codes. Median elapsed review time is 80 days. openFDA lists no recall records naming the company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 303
Product codes: 90
Median review: 80 days
Recall records: 0

How does FDA spell Depuy, Inc.?

FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.

Which product codes does Depuy, Inc. file in?

90 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
Code	Device	Clearances	Median review	Latest
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	45	81 days	20 May 1998
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	31	87 days	22 July 2004
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	24	94 days	28 May 2004
HWC	Screw, Fixation, Bone	14	90 days	22 June 1998
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	12	82 days	24 January 1997
KWP	Appliance, Fixation, Spinal Interlaminal	11	74 days	3 December 1998
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	7	60 days	31 March 1993
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	6	24 days	26 September 1995
HSB	Rod, Fixation, Intramedullary And Accessories	6	29 days	14 November 2003
KWQ	Appliance, Fixation, Spinal Intervertebral Body	6	77 days	3 November 1997
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	5	121 days	14 October 1994
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	5	49 days	29 April 1993
JDW	Pin, Fixation, Threaded	5	68 days	14 July 1999
MBV	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer	5	23 days	1 September 1983
HRS	Plate, Fixation, Bone	4	74 days	11 January 2000
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	4	7 days	20 May 2002
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	4	176 days	25 May 1995
FYA	Gown, Surgical	3	169 days	21 October 1997
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	3	42 days	20 January 1983
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	3	87 days	9 October 1997
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	3	89 days	16 January 1992
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	3	166 days	28 April 1994
DXQ	Blood Pressure Cuff	2	71 days	30 July 1985
FMQ	Restraint, Protective	2	64 days	24 July 1997
HRX	Arthroscope	2	144 days	9 May 1995

Showing the 25 they file in most, of 90.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Depuy, Inc. had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Depuy, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K043058	PINNACLE CONSTRAINED ACETABULAR LINERS	KWZ	14 March 2005	129
K042664	LPS UPPER EXTREMITY	JDC	8 December 2004	71
K041085	LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY	JWH	22 July 2004	87
K033959	LPS	JWH	1 July 2004	192
K040544	DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062	LPH	28 May 2004	87
K021478	DELTA SHOULDER	PHX	18 November 2003	559
K033329	DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS	HSB	14 November 2003	29
K032151	DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS	JWH	26 September 2003	74
K020541	AGILITY ANKLE REVISION PROSTHESIS	HSN	20 May 2002	90
K011810	ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING	KRO	7 September 2001	88

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Watch what Depuy, Inc. files next

Get an email when this company clears a new device, or when anything is recalled in a product code you follow.

Start watching with DeviceSignal

Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.