Medical device manufacturer
DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc. holds 209 FDA 510(k) clearances across 44 product codes. Median elapsed review time is 72 days. openFDA lists 740 recall records naming the company. FDA publishes it under 9 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 209
- Product codes
- 44
- Median review
- 72 days
- Recall records
- 740
How does FDA spell DePuy Orthopaedics, Inc.?
FDA publishes this company under 9 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| DEPUY ORTHOPAEDICS | device/registrationlisting | normalised |
| DEPUY ORTHOPAEDICS, INC. | device/registrationlisting | normalised |
| DePuy Orthopaedics, Inc. | device/enforcement | normalised |
| DePuy Orthopaedics, Inc. | device/recall | normalised |
| DePuy Orthopaedics, Inc. | device/510k | normalised |
| Depuy Orthopaedics | device/510k | normalised |
| Depuy Orthopaedics Inc. | device/recall | normalised |
| Depuy Orthopaedics Inc. | device/enforcement | normalised |
Showing 8 of 9.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does DePuy Orthopaedics, Inc. file in?
44 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 33 | 58 days | |
| HRS | Plate, Fixation, Bone | 18 | 72 days | |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 17 | 75 days | |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 15 | 118 days | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 12 | 42 days | |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 12 | 86 days | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 9 | 62 days | |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 9 | 28 days | |
| LOD | Bone Cement | 9 | 76 days | |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 7 | 75 days | |
| PHX | Shoulder Prosthesis, Reverse Configuration | 6 | 32 days | |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 5 | 30 days | |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | 5 | 99 days | |
| HAW | Neurological Stereotaxic Instrument | 4 | 52 days | |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 4 | 90 days | |
| FTM | Mesh, Surgical | 3 | 147 days | |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 3 | 80 days | |
| MBB | Bone Cement, Antibiotic | 3 | 27 days | |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 3 | 83 days | |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 2 | 85 days | |
| HWC | Screw, Fixation, Bone | 2 | 69 days | |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 2 | 29 days | |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 2 | 66 days | |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 | 22 days | |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 | 60 days |
Showing the 25 they file in most, of 44.
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
Has DePuy Orthopaedics, Inc. had a recall?
openFDA lists 740 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1456-2024Class IIOpen, ClassifiedMBH
Product incorrectly labelled.
Z-1263-2023Class IIOpen, ClassifiedKRO
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Z-1264-2023Class IIOpen, ClassifiedKRO
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Z-1265-2023Class IIOpen, ClassifiedKRO
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Z-1266-2023Class IIOpen, ClassifiedKRO
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Showing the 5 most recently initiated of 740.
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
What has DePuy Orthopaedics, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K252887 | DePuy ATTUNE Knee System | OIY | 254 | |
| K231503 | CUPTIMIZE Advanced | LLZ | 90 | |
| K213839 | DePuy Corail AMT Hip Prosthesis | LZO | 28 | |
| K210167 | DELTA XTEND Reverse Shoulder System | PHX | 29 | |
| K203167 | DePuy Corail AMT Hip Prosthesis | LZO | 27 | |
| K202472 | ACTIS Duofix Hip Prosthesis | LPH | 54 | |
| K201347 | DePuy ATTUNE Total Knee System | OIY | 28 | |
| K193540 | TRUMATCH Personalized Solutions | JWH | 179 | |
| K193398 | Summit DuoFix HA Coating | MEH | 60 | |
| K192946 | DePuy Corail AMT Hip Prosthesis | LZO | 39 |
Source: openFDA device/510k · retrieved
Where is DePuy Orthopaedics, Inc. registered?
FDA lists 3 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what DePuy Orthopaedics, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
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.