DePuy Synthes: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “DePuy Synthes” (first 1979, latest 2024), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 89 days. Since 2017 the median was 95 days, against 91 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 56 |
| 2016 | 0 | — |
| 2017 | 2 | 170 |
| 2018 | 2 | 126 |
| 2019 | 2 | 80 |
| 2020 | 3 | 59 |
| 2021 | 1 | 55 |
| 2022 | 2 | 110 |
| 2023 | 1 | 27 |
| 2024 | 5 | 260 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name DePuy Synthes took a median 95 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 10 | 10 |
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| JDP | Condylar Plate Fixation Implant | 1 | 1 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
Review panels
- Orthopedic (20)
Most recent DePuy Synthes 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233696 | DePuy Synthes Retrograde Femoral Nail Advanced System | HSB | 2024-08-01 | 258 |
| K233256 | Robotic Integration Instruments | OLO | 2024-06-17 | 263 |
| K233255 | CROSSNAV Navigation Enabled Instruments | OLO | 2024-06-17 | 263 |
| K233254 | TELIGEN System Navigation Ready Instruments | OLO | 2024-06-14 | 260 |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System | HRS | 2024-03-21 | 127 |
| K231922 | DEPUY SYNTHES MAXFRAME AUTOSTRUT System | KTT | 2023-07-26 | 27 |
| K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular System | HRS | 2022-09-20 | 90 |
| K213563 | DePuy Synthes Radial Head Replacement System | KWI | 2022-03-18 | 129 |
| K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) | HRS | 2021-06-02 | 55 |
| K203414 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System | HRS | 2020-12-16 | 27 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named DePuy Synthes.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Depuy, Inc. (303 510(k)s)
- DePuy Orthopaedics, Inc. (210 510(k)s)
- Depuy Spine, Inc. (71 510(k)s)
- Depuy Mitek, A Johnson & Johnson Company (58 510(k)s)
- Depuy Ireland UC (50 510(k)s)
- Depuy Mitek (15 510(k)s)
- Depuy Ace Medical Co. (10 510(k)s)
- Depuy Motech Acromed (4 510(k)s)
- Depuy Spine, A Johnson & Johnson Company (4 510(k)s)
- Depuy Mitek, A Johnson and Johnson Company (3 510(k)s)
- Depuy Mitek, Inc., A Johnson and Johnson Company (3 510(k)s)
- Depuy Synthes Spine (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under DePuy Synthes?
FDA lists 20 510(k) clearances under the applicant name “DePuy Synthes” (first 1979, latest 2024), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by DePuy Synthes?
The median time from FDA receipt to decision across 510(k)s cleared under the name DePuy Synthes is 89 days. Since 2017: 95 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under DePuy Synthes?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 10); OLO (Orthopedic Stereotaxic Instrument, 3); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 2).
Next steps
- See all 20 DePuy Synthes clearances with predicates and recalls
- Run predicate analysis for product code HRS, DePuy Synthes's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.